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Volume 29 No. 3<br />

<strong>Autumn</strong> <strong>2019</strong><br />

<strong>Gastroenterology</strong> <strong>Today</strong><br />

Passionate about Endoscopy?<br />

We are clearing NHS trust waiting lists<br />

one weekend at a time, and<br />

we need your help<br />

18 Week Support <strong>Gastroenterology</strong>:<br />

Building Expert Teams<br />

In this issue<br />

An unusual case of oesophagitis<br />

Assessment of thyroid profile in<br />

patients with fissure in ANO


Life feels good<br />

when Crohn’s is<br />

under control 1,2<br />

Entocort ® CR is indicated for the induction<br />

of remission in adults with mild to moderate<br />

Crohn’s disease affecting the ileum and/or<br />

the ascending colon 3<br />

Oral modified-release budesonide preparations are formulated to target specific types of<br />

inflammatory bowel disease. To ensure your patient receives a budesonide indicated for Crohn’s<br />

disease, prescribe Entocort ® CR by brand.<br />

ENTOCORT CR 3mg Capsules (budesonide) - Prescribing<br />

Information<br />

Please consult the Summary of Product Characteristics (SmPC) for full<br />

prescribing Information<br />

Presentation: Hard gelatin capsules for oral administration with an<br />

opaque, light grey body and an opaque, pink cap marked CIR 3mg in<br />

black radial print. Contains 3mg budesonide. Indications: Induction of<br />

remission in patients with mild to moderate Crohn’s disease affecting the<br />

ileum and/or the ascending colon. Induction of remission in patients with<br />

active microscopic colitis. Maintenance of remission in patients with<br />

microscopic colitis. Dosage and administration: Active Crohn’s disease<br />

(Adults): 9mg once daily in the morning for up to eight weeks. Full effect<br />

achieved in 2-4 weeks. When treatment is to be discontinued, dose<br />

should normally be reduced in final 2-4 weeks. Active microscopic colitis<br />

(Adults): 9mg once daily in the morning. Maintenance of microscopic<br />

colitis (Adults): 6mg once daily in the morning, or the lowest effective<br />

dose. Paediatric population: Not recommended. Older people: No<br />

special dose adjustment recommended. Swallow whole with water. Do<br />

not chew. Contraindications: Hypersensitivity to the active substance or<br />

any of the excipients. Warnings and Precautions: Side effects typical of<br />

corticosteroids may occur. Visual disturbances may occur. If a patient<br />

presents with symptoms such as blurred vision or other visual<br />

disturbances they should be considered for referral to an<br />

ophthalmologist for evaluation of the possible causes. Systemic effects<br />

may include glaucoma and when prescribed at high doses for<br />

prolonged periods, Cushing’s syndrome, adrenal suppression, growth<br />

retardation, decreased bone mineral density and cataract. Caution in<br />

patients with infection, hypertension, diabetes mellitus, osteoporosis,<br />

peptic ulcer, glaucoma or cataracts or with a family history of diabetes<br />

or glaucoma. Particular care in patients with existing or previous history<br />

of severe affective disorders in them or their first degree relatives.<br />

Caution when transferring from glucocorticoid of high systemic effect to<br />

Entocort CR. Chicken pox and measles may have a more serious course<br />

in patients on oral steroids. They may also suppress the HPA axis and<br />

reduce the stress response. Reduced liver function may increase<br />

systemic exposure. When treatment is discontinued, reduce dose over<br />

last 2-4 weeks. Concomitant use of CYP3A inhibitors, such as<br />

ketoconazole and cobicistat-containing products, is expected to<br />

increase the risk of systemic side effects and should be avoided unless<br />

the benefits outweigh the risks. Excessive grapefruit juice may increase<br />

systemic exposure and should be avoided. Patients with fructose<br />

intolerance, glucose-galactose malabsorption or sucrose-isomaltase<br />

insufficiency should not take Entocort CR. Monitor height of children who<br />

use prolonged glucocorticoid therapy for risk of growth suppression.<br />

Interactions: Concomitant colestyramine may reduce Entocort CR<br />

uptake. Concomitant oestrogen and contraceptive steroids may<br />

increase effects. CYP3A4 inhibitors may increase systemic exposure.<br />

CYP3A4 inducers may reduce systemic exposure. May cause low<br />

values in ACTH stimulation test. Fertility, pregnancy and lactation:<br />

Only to be used during pregnancy when the potential benefits to the<br />

mother outweigh the risks for the foetus. May be used during breast<br />

feeding. Adverse reactions: Common: Cushingoid features,<br />

hypokalaemia, behavioural changes such as nervousness, insomnia,<br />

mood swings and depression, palpitations, dyspepsia, skin reactions<br />

(urticaria, exanthema), muscle cramps, menstrual disorders.<br />

Uncommon: anxiety, tremor, psychomotor hyperactivity. Rare:<br />

aggression, glaucoma, cataract, blurred vision, ecchymosis. Very rare:<br />

Anaphylactic reaction, growth retardation. Prescribers should consult<br />

the summary of product characteristics in relation to other adverse<br />

reactions. Marketing Authorisation Numbers, Package Quantities and<br />

basic NHS price: PL 36633/0006. Packs of 100 capsules: £84.15. Legal<br />

category: POM. Marketing Authorisation Holder: Tillotts Pharma UK<br />

Ltd, The Stables, Wellingore Hall, Wellingore, Lincoln, LN5 0HX. Date of<br />

preparation of PI: November 2018<br />

Adverse events should be reported. Reporting forms<br />

and information can be found at https://yellowcard.<br />

mhra.gov.uk. Adverse events should also be reported<br />

to Tillotts Pharma UK Ltd. Tel: 01522 813500.<br />

References: 1. Greenberg GR, et al. N Engl J Med 1994; 331: 836-841.<br />

2. Rezaie A, et al. Cochrane Database Syst Rev 2015; 6: CD000296.<br />

3. Entocort ® CR 3mg Capsules – Summary of Product Characteristics.<br />

November 2018.<br />

Date of preparation: January <strong>2019</strong>. PU-00237.


CONTENTS<br />

CONTENTS<br />

5 EDITORS COMMENT<br />

Matthew’s Perspective:<br />

6 CASE REPORT An unusual case of oesophagitis<br />

8 FEATURE Assessment of thyroid profile in patients with<br />

fissure in ano in the South Indian population<br />

15 NEWS<br />

28 BSG POSTERS<br />

30 COMPANY NEWS<br />

COVER STORY<br />

What approach has 18 Week Support taken with<br />

regards to building an expert insourcing team?<br />

What approach has 18 Week Support<br />

taken with regards to building an<br />

expert insourcing team?<br />

<strong>Gastroenterology</strong> <strong>Today</strong><br />

This issue edited by:<br />

Andy Poullis<br />

c/o Media Publishing Company<br />

Media House<br />

48 High Street<br />

SWANLEY, Kent BR8 8BQ<br />

Dr Matthew Banks is the Clinical Director for 18 Week Support <strong>Gastroenterology</strong>. He believes it starts with recruiting the<br />

best clinicians. ‘At 18 Week Support we set the bar very high. We only recruit clinicians whose JAG performance data is well<br />

above the national standards. In addition, we monitor each clinician’s KPIs while they work with 18 WS. While the JAG data<br />

is an excellent quality indicator, we now want to go a step beyond that and monitor the Non-Technical skills (NTS) of each<br />

clinician as well. We now know that NTS plays an important role in safe and effective team performance. Therefore, in our<br />

quest to develop excellent teams who deliver a world-class service, we must ADVERTISING focus on NTS’. & CIRCULATION:<br />

Media Publishing Company<br />

Tammy and Lisa’s Perspective:<br />

Media House, 48 High Street<br />

Tammy Kingstree is Lead Nurse for Endoscopy.<br />

SWANLEY, Kent, BR8 8BQ<br />

‘It is extremely important that there are good working relationships within the team. This starts with strong leadership from<br />

our senior nurse coordinators who are trained to manage the patient pathway, Tel: manage 01322 a team 660434 of staff Fax: they may 01322 not know 666539<br />

and to deal effectively with any issues which may arise on the day’. E: info@mediapublishingcompany.com<br />

www.MediaPublishingCompany.com<br />

Lisa Phillips is Lead Nurse for Endoscopy.<br />

‘The team objectives are clear. Excellent patient experience and good patient outcomes. Because the objectives are clear,<br />

team cohesion and focus are exceptionally good. It therefore shouldn’t matter PUBLISHING that we are in an unfamiliar DATES: endoscopy unit,<br />

the service should be seamless. If it isn’t, we do not stop until we get it right. February, June and October.<br />

If you have an excellent NHS record and want to help clear NHS waiting list backlogs, reduce RTT waiting times and provide<br />

high-quality patient care, get in touch by calling on 020 3892 6162 or email COPYRIGHT:<br />

Gastro.Recruitment@18weeksupport.com<br />

Media Publishing Company<br />

Media House<br />

48 High Street<br />

SWANLEY, Kent, BR8 8BQ<br />

PUBLISHERS STATEMENT:<br />

The views and opinions expressed in<br />

this issue are not necessarily those of<br />

the Publisher, the Editors or Media<br />

Publishing Company.<br />

Matthew’s Perspective:<br />

Dr Matthew Banks is the Clinical Director for 18 Week Support <strong>Gastroenterology</strong>.<br />

He believes it starts with recruiting the best clinicians. ‘At 18 Week Support we set<br />

the bar very high. We only recruit clinicians whose JAG performance data is well<br />

above the national standards. In addition, we monitor each clinician’s KPIs while<br />

they work with 18 WS. While the JAG data is an excellent quality indicator, we<br />

now want to go a step beyond that and monitor the Non-Technical skills (NTS) of<br />

each clinician as well. We now know that NTS plays an important role in safe and<br />

effective team performance. Therefore, in our quest to develop excellent teams who<br />

deliver a world-class service, we must focus on NTS’.<br />

Tammy and Lisa’s Perspective:<br />

Tammy Kingstree is Lead Nurse for Endoscopy.<br />

‘It is extremely important that there are good working relationships within the team.<br />

This starts with strong leadership from our senior nurse coordinators who are trained<br />

to manage the patient pathway, manage a team of staff they may not know and to<br />

deal effectively with any issues which may arise on the day’.<br />

Lisa Phillips is Lead Nurse for Endoscopy.<br />

‘The team objectives are clear. Excellent patient experience and good patient<br />

outcomes. Because the objectives are clear, team cohesion and focus are exceptionally<br />

good. It therefore shouldn’t matter that we are in an unfamiliar endoscopy unit, the<br />

service should be seamless. If it isn’t, we do not stop until we get it right.<br />

If you have an excellent NHS record and want to help clear NHS waiting list backlogs,<br />

reduce RTT waiting times and provide high-quality patient care, get in touch by<br />

calling on 020 3892 6162 or email Gastro.Recruitment@18weeksupport.com<br />

Next Issue Spring 2020<br />

Subscription Information – <strong>Autumn</strong> <strong>2019</strong><br />

<strong>Gastroenterology</strong> <strong>Today</strong> is a tri-annual<br />

publication currently sent free of charge to<br />

all senior qualified Gastroenterologists in<br />

the United Kingdom. It is also available<br />

by subscription to other interested individuals<br />

and institutions.<br />

UK:<br />

Other medical staff - £18.00 inc. postage<br />

Non-medical Individuals - £24.00 inc. postage<br />

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Rest of the World:<br />

Individuals - £48.00 inc. postage<br />

Institutions<br />

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We are also able to process your<br />

subscriptions via most major credit<br />

cards. Please ask for details.<br />

Cheques should be made<br />

payable to MEDIA PUBLISHING.<br />

Designed in the UK by me&you creative<br />

GASTROENTEROLOGY TODAY - AUTUMN <strong>2019</strong><br />

3


TVEG & GENIE Presents<br />

A STUDY DAY<br />

Sponsored by<br />

7th December <strong>2019</strong><br />

The specialised area of <strong>Gastroenterology</strong>/Endoscopy is an area where<br />

we pride ourselves with working alongside the British Society of<br />

<strong>Gastroenterology</strong> (BSG).<br />

The BSG aims to provide quality improvement to create the same level<br />

of care for patients and provide high standards therefore protocols<br />

and policies are updated on a regular basis.<br />

So even when working for a NHS Trust or a company like 18 Week<br />

Support, all Endoscopy units adhere to BSG, JAG (Joint Advisory<br />

Service) and GRS (Global Rating Score). With this in mind, staff in<br />

either a private sector or the NHS needs to be updated. The whole<br />

team from the Consultants to Clinical Nurse Endoscopists and the<br />

endoscopy nurses require these resources to keep updated, therefore<br />

the most efficient way is education.<br />

Education is at the forefront of Health especially with the changes<br />

in recent times, such as the Nursing and Midwifery Council<br />

revalidation process and the Darzi report and recommendations. It’s<br />

vital to support our workforce with up-to-date events to provide high<br />

quality education.<br />

The education group TVEG (Thames Valley Endoscopy Group) and<br />

GENIE (<strong>Gastroenterology</strong> Endoscopy Nurses in Essex) have been<br />

running for over 25yrs, merging together to cover a large area of<br />

Essex, London and the surrounding areas. We have provided annual<br />

study days for Endoscopy Nurses and of late Specialist and Nurse<br />

Endoscopists. So that we can capture all regions, in the past we<br />

have held studies in varying trusts. Education is vital to provide high<br />

quality services and have members of the team working with up to<br />

date knowledge and endeavor to make across all NHS trusts to the<br />

same standards. Therefore, it’s with great privilege this year to team<br />

up with 18 Week Support to give another outstanding study day.<br />

We have grown immensely over the years and with their continuing<br />

commitment, we hope to get NHS and the 18 Week Support staff to<br />

provide an even higher quality service to NHS trusts.<br />

Holding the study day on a Saturday opens it up for all to attend and<br />

everyone is grateful for the speakers giving up their time.<br />

The program for this event will be released in November, tickets will<br />

be sold via Eventbrite, feel free to attend. Lunch and Refreshments will<br />

be provided<br />

We will provide expert advice on latest updates, tips and tricks<br />

with hands on techniques and, as always popular, we will have live<br />

Endoscopy from Professor of <strong>Gastroenterology</strong> Prof Mathew Banks<br />

and Clinical Nurse Endoscopist Sr Sara Brogden.<br />

Could you please send any enquires to sara.brogden@nhs.net<br />

Delegates must all be working within Endoscopy/<strong>Gastroenterology</strong><br />

and the attendance will be capped at 125- 130 delegates.<br />

This study day is run as a charity. Please note, if you already work shifts<br />

with 18 Week Support and visit their stand or if you successfully apply<br />

to work with 18 Week Support on the day and complete a shift by the<br />

31st of March 2020 you will be able claim your attendance fee back.<br />

Yours sincerely,<br />

Sara E M Brogden<br />

(Chair of TVEG & GENIE)<br />

About you<br />

If you have an excellent NHS record and want to help clear NHS<br />

waiting list backlogs, reduce RTT waiting times and provide highquality<br />

patient care, get in touch by calling on 0203 966 9081<br />

or email us at recruitment@18weeksupport.com<br />

Our mission: giving up-to-date education, providing current criteria,<br />

quality and commitment to all. 18 Week support will help to provide<br />

this, showing that we can continue improving care and support to our<br />

health professional patients, and trusts and continue to work with the<br />

key points of BSG, JAG and GRS.<br />

This year the study day will be held on Saturday 7th December <strong>2019</strong><br />

at the 1st Floor Educational Centre University College Hospital, 250<br />

Euston Road, NW1 2PG<br />

www.18weeksupport.com<br />

London<br />

3rd Floor, 19-21 Great Tower Street<br />

London | EC3R 5AR | 020 3869 8790


EDITORS COMMENT<br />

EDITORS COMMENT<br />

“If unsure<br />

on the<br />

suitability of<br />

an article or<br />

case report<br />

then please<br />

feel free to<br />

contact the<br />

editorial<br />

office so<br />

we can give<br />

advice.”<br />

<strong>Gastroenterology</strong> <strong>Today</strong> going from strength to strength<br />

I am pleased to be able to bring a range of reports, features and news in this edition<br />

of GT. We have had an increase in submitted articles enabling us to bring a range of<br />

articles.<br />

Another case report from St George’s reminding us all that occasionally reflux symptoms<br />

have slightly more to them....<br />

An interesting report from India reminds us that, in the population studied, systemic disease<br />

still can manifest with local/bowel symptoms.<br />

Our news section highlights a number of dynamic initiatives in the world of<br />

gastroenterology.<br />

At GT we want to fully support all aspiring gastroenterologists and are also keen to support<br />

submissions. If unsure on the suitability of an article or case report then please feel free<br />

to contact the editorial office so we can give advice. We accept a wide variety of materials<br />

from personal view, mini-reviews, case reports, studies to news of important GI related<br />

events.<br />

We are pleased to announce that we will be moving back to 4 publications a year due to<br />

interest in the journal and the volume of work submitted.<br />

I think I have achieved the impossible - an editorial without reference to the NHS pension<br />

disaster or Brexit!!<br />

Andy Poullis<br />

St George’s Hospital, London<br />

GASTROENTEROLOGY TODAY - AUTUMN <strong>2019</strong><br />

5


CASE REPORT<br />

AN UNUSUAL CASE OF<br />

OESOPHAGITIS<br />

K Punjabi, V Vakeeswarasarma, A Poullis<br />

Department of <strong>Gastroenterology</strong>, St George’s Hospital<br />

GASTROENTEROLOGY TODAY - AUTUMN <strong>2019</strong><br />

6<br />

Abstract<br />

We report a case of a patient with multisystem systemic lupus<br />

erythematosus (SLE), requiring immunosuppressant therapy, who<br />

presented with symptoms of gastro-oesophageal reflux a year after<br />

starting Mycophenolate Mofetil (MMF). An initial gastroscopy showed<br />

severe oesophagitis with ulceration with oesophageal biopsies<br />

showing chronic inflammation. Treatment was initiated with high dose<br />

proton pump inhibitor therapy and the addition of a histamine receptor<br />

antagonist when no endoscopic improvement was identified. Repeat<br />

oesophageal biopsies suggested a possible infective element to the<br />

gastro-oesophageal reflux. Polymerase chain reaction (PCR) detected<br />

EBV DNA in serology (at 160 IU/ml) and on oesophageal biopsies.<br />

A diagnosis of EBV oesophagitis was made and treated with a one<br />

month course of Valcyclovir. On initiation with this treatment the reflux<br />

symptoms rapidly resolved. Following the diagnosis, the dose of<br />

MMF was reduced. Further repeat PCR on blood and biopsy samples<br />

have returned negative. Oesophageal manifestation of EBV are rarely<br />

reported and should be considered in patients with oesophageal<br />

ulceration at endoscopy not responding to anti-reflux medications.<br />

Diagnosis is most sensitive with polymerase chain reaction testing<br />

rather than cellular pathological examination or serological markers to<br />

allow for prompt management.<br />

Case History<br />

A 43 year old woman was initially referred to gastroenterology clinic<br />

for symptoms of indigestion and burning reflux one year after initiating<br />

Mycophenolate Mofetil (MMF). She was under various speciality teams<br />

for SLE with multisystem involvement, including Sjogren’s syndrome,<br />

interstitial lung disease, nephrotic syndrome, and neurologic SLE.<br />

Initially she was managed on azathioprine but changed to MMF after<br />

renal biopsy confirmed SLE membranous nephritis, which was titrated<br />

to 1.5g twice a day and a background low dose prednisolone was<br />

continued. Her initial gastroscopy showed severe oesophagitis with<br />

ulceration and biopsies showed chronic inflammation so was started<br />

on high dose omeprazole at 40mg twice a day, which only partially<br />

improved the reflux symptoms. A repeat gastroscopy showed severe<br />

oseophagitis, so her therapy was changed to esomprazole 40mg<br />

once a day and ranitidine 150mg once a day. Biopsies at follow up<br />

suggested it was more than simple severe gastro-oesophageal reflux<br />

and suggestive of an infective aetiology.<br />

A serological viral screen identified a reactive HSV-1 IgG, suggesting<br />

a recent HSV infection, but a negative HIV, EBV IgM and CMV. Viral<br />

polymerase chain reaction (PCR) identified 160 IU/ml of EBV DNA.<br />

PCR for EBV DNA carried out on oesophageal biopsies confirmed the<br />

diagnosis of EBV oesophagitis a year after initial presentation and the<br />

patient was initiated on valcyclovir 1g three times a day for one month.<br />

On this treatment the reflux symptoms gradually resolved.<br />

At endoscopic follow up there was significant improvement to the<br />

oesophageal inflammation and biopsies returned negative for EBV DNA.<br />

At clinical follow up she remains well.<br />

Discussion<br />

Infective oesophagitis in a healthy individual is a relatively rare condition.<br />

However, the prevalence rises in certain high-risk populations, such<br />

as those with a compromised immune system. Infection could also<br />

be secondary to other causes, such as diabetes mellitus, malignancy,<br />

gastro-oesophageal reflux disease (GORD) or chronic corticosteroid<br />

use (1).<br />

Causes of infective oesophagitis can be sub-divided into bacterial, viral<br />

and fungal. Risk factors can range from immunosuppressive conditions<br />

or chemotherapies, neutropenia, antimicrobial therapy and HIV infection<br />

(2,3). Infectious agents can get in contact with the oesophageal mucosa<br />

either by direct contact, through lymphatics and vascular systems, or by<br />

direct extension from adjacent mediastinal structures (2).<br />

The most common cause is the fungal infection Candida albicans.<br />

Candida is a dimorphic yeast and usually invades tissue by the<br />

formation of hyphae in the distal third of the oesophagus, leaving behind<br />

superficial yellow-white plaques. This infection is likely to be found in<br />

patients with acquired immunodeficiency syndrome (3) and steroid use.<br />

Bacterial oesophagitis is less common than fungal and is usually found<br />

in sites of oesophageal mucosal disruption, likely secondary to acid<br />

reflux (4). As mentioned, this incidence increases when a person is<br />

immunocompromised. Normal oesophageal flora consists of grampositive<br />

bacteria, commonly Streptococci viridans. However, this can<br />

change to gram-negative due to reflux, leading to more complications<br />

(5). In immunocompromised patients, bacterial infection can be<br />

polymicrobial, and in some cases of HIV patients, mycobacterial.<br />

Cytomegalovirus (CMV) is one of the commonest viral causes for<br />

infective oesophagitis, usually occurring in patients post solid organ<br />

transplant (1). These patients are often given prophylactic treatment,<br />

however despite this, there is still a proportion that develop delayed<br />

onset CMV infection. Herpes Simplex Virus infection type 1 (HSV-<br />

1) is typically the cause over HSV-2 for oesophageal infection. On<br />

endoscopy, diagnostic raised edge ulcers are seen, forming a punched


CASE REPORT<br />

out or volcano-like appearance. PCR on biopsy samples can confirm<br />

the diagnosis (6).<br />

In this case, EBV was the cause of the oesophagitis. EBV is thought to<br />

activate immune-mediated mechanisms which ultimately leads to tissue<br />

damage (7). During investigation, it is important not to solely rely on a<br />

standard peripheral blood exam and routine histopathology, as this may<br />

lead to an incorrect diagnosis (8). Diagnosis can be confirmed with PCR<br />

on biopsy specimens. On endoscopy, there is ulceration, which differs<br />

from HSV as the ulcers seen are usually deeper, more linear and located<br />

in the mid-oesophagus. The main management is with acyclovir therapy,<br />

which should lead to resolution of the oesophagus confirmed with a<br />

repeat endoscopy (9).<br />

Oesophagitis due to EBV infection should be considered in patients<br />

with recurrent symptoms and endoscopic appearance of oesophageal<br />

ulceration. Our case identifies the significance of PCR testing of biopsy<br />

samples to allow for prompt diagnosis and appropriate management.<br />

References<br />

1. O’Rourke A. Infective oesophagitis. Current Opinion in<br />

Otolaryngology & Head and Neck Surgery. 2015;23(6):459-463.<br />

2. De Prez C. Oesophagites infectieuses. Acta Endoscopica.<br />

2002;32(2):119-123.<br />

3. Asayama N, Nagata N, Shimbo T, Nishimura S, Igari T, Akiyama J et<br />

al. Relationship between clinical factors and severity of esophageal<br />

candidiasis according to Kodsi’s classification. Diseases of the<br />

Esophagus. 2013;27(3):214-219.<br />

4. Radhi J, Schweiger F. Bacterial oesophagitis in an<br />

immunocompromised patient. Postgraduate Medical Journal.<br />

1994;70(821):233-234.<br />

5. Yang L, Francois F, Pei Z. Molecular Pathways: Pathogenesis and<br />

Clinical Implications of Microbiome Alteration in Esophagitis and<br />

Barrett Esophagus. Clinical Cancer Research. 2012;18(8):2138-<br />

2144.<br />

6. Lee B. A rare cause of dysphagia: Herpes simplex esophagitis.<br />

World Journal of <strong>Gastroenterology</strong>. 2007;13(19):2756.<br />

7. Pape M, Mandraveli K, Sidiropoulos I, Koliouskas D, Alexiou-Daniel<br />

S, Frantzidou F. Unusual Epstein-Barr esophageal infection in an<br />

immunocompetent patient: a case report. Journal of Medical Case<br />

Reports. 2009;3(1):7314.<br />

8. Annaházi A, Terhes G, Deák J, Tiszlavicz L, Rosztóczy A,<br />

Wittmann T et al. Fulminant Epstein–Barr virus esophagitis in an<br />

immunocompetent patient. Endoscopy. 2011;43(S 02):E348-E349.<br />

9. Baehr P, McDonald G. Esophageal infections: Risk factors,<br />

presentation, diagnosis, and treatment. <strong>Gastroenterology</strong>.<br />

1994;106(2):509-532.<br />

POSTER SUBMISSIONS<br />

If you have submitted a poster to this years BSG<br />

or ENDOLIVE events and would like it published in<br />

<strong>Gastroenterology</strong> <strong>Today</strong> please forward a PDF of your<br />

poster to the email address listed below.<br />

Material submitted will be seen by those working within all<br />

UK gastroenterology departments and endoscopy units.<br />

All submissions should be forwarded to info@mediapublishingcompany.com<br />

If you have any queries please contact the publisher Terry Gardner via:<br />

info@mediapublishingcompany.com<br />

GASTROENTEROLOGY TODAY - AUTUMN <strong>2019</strong><br />

7


FEATURE<br />

ASSESSMENT OF THYROID PROFILE<br />

IN PATIENTS WITH FISSURE IN ANO<br />

IN THE SOUTH INDIAN POPULATION<br />

Saveetha Institute of Medical and Technical Science, Chennai, India<br />

Madhumitha Prabhakaran, Bharath N, Arcot Rekha<br />

Abstract<br />

Objectives<br />

Keywords: Hypothyroidism, Fissure in ano, Anal fissure,<br />

constipation, thyroid profile, lower gastrointestinal complaints<br />

Background: A precipitating history of constipation is found in<br />

approximately 20% of patients with anal fissures. Hard feces result<br />

in local trauma to the rectal mucosa which in turn secondarily<br />

activates internal anal sphincter hypertonia. As the maximum<br />

resting anal pressure (MRAP) is usually greater than 90 mm Hg<br />

in patients with fissures such hypertonia will compress these end<br />

arteries and cause ischemia of the posterior commissure and<br />

eventually anal fissures. Constipation is one of the classic signs<br />

of hypothyroidism. The most probable pathological reason is the<br />

intestinal edema due to mucopolysaccharide accumulation in<br />

gastrointestinal tissue.<br />

Method: This is a prospective, observational study. We first<br />

identified the male and female patients presenting to the outpatient<br />

department with various lower abdominal complaints. Informed<br />

consent for inclusion in the study was obtained. A thyroid assay<br />

was ordered for all the anal fissure patients who were admitted for<br />

surgical procedures.<br />

1. To determine the incidence of patients with lower gastrointestinal<br />

symptoms attending the surgical outpatient department.<br />

2. To find the incidence of fissure in ano among patients with lower<br />

gastrointestinal symptoms attending the surgical outpatient<br />

department.<br />

3. To analyze the pattern of thyroid profile in patients with fissure in ano<br />

Background<br />

An anal fissure is defined as split in the mucosa extending from the anal<br />

verge to the dentate line. The fissures usually present with pain and<br />

rectal bleeding.<br />

A precipitating history of constipation is found in approximately 20%<br />

of patients with fissure in ano. Hard feces result in local trauma to<br />

the rectal mucosa which in turn secondarily activates internal anal<br />

sphincter hypertonia. Subsequent sphincter spasm leads to further<br />

constipation and a vicious cycle is created. Treatment modalities such<br />

as anal dilatation and internal sphincterotomy aim to break this cycle by<br />

disrupting the internal anal sphincter. [1]<br />

GASTROENTEROLOGY TODAY - AUTUMN <strong>2019</strong><br />

Result: 38.2% of patients with lower gastrointestinal complaints<br />

and 3.6% of the total number of patients presenting to the<br />

surgical OPD were attributed to an anal fissure. The incidence<br />

of hypothyroidism in patients with an anal fissure is 32%. Since<br />

the incidence of hypothyroidism in our study is higher than<br />

the prevalence of hypothyroidism in the general population as<br />

documented by multiple studies in the past, we can conclude that<br />

there is a significant association between hypothyroidism and<br />

development of anal fissures.<br />

Conclusion: By analyzing the thyroid profile in patients with anal<br />

fissures, we found an association between the two entities. This<br />

information can be used to predict and prevent anal fissures in<br />

hypothyroid patients.<br />

Aim<br />

To study the thyroid profile of patients presenting to the surgery<br />

OPD with constipation and a diagnosis of fissure in ano.<br />

The posterior midline of the anus is supplied by end arteries which<br />

pass through the internal anal sphincter before reaching the posterior<br />

commissure. The mean arteriolar blood pressure of the end arteries is<br />

85 mm Hg. As a result, it is thought that the blood flow to this area is<br />

potentially deficient. [2] Fissure in ano patients have maximum resting<br />

anal pressure (MRAP) greater than 90 mm Hg usually. This state of<br />

hypertonia will compress the end arteries, leading to ischemia of the<br />

posterior commissure and finally anal fissures. [3]<br />

Some might say that hypertonia arises secondary to pain. But the<br />

inability to provide relief from the hypertonia by using painkillers<br />

disproves this theory. [4]<br />

Constipation is one of the many classic signs of hypothyroidism.<br />

The pathophysiological changes observed in the digestive tracts<br />

of hypothyroid patients have not been definitely determined, but<br />

according to recent studies, a deficiency of thyroid hormone<br />

weakens the contractions of the muscles that line the digestive<br />

tract. The most probable pathological reason is the accumulation of<br />

mucopolysaccharides, especially hyaluronic acid in the gastrointestinal<br />

8


CHART 2: Diagnosis of female patients presenting with<br />

lower gastrointestinal complaints<br />

FEATURE<br />

tissue leading to intestinal edema. This reduction in the motor activity<br />

delays the intestinal transit time of feces which allows more water<br />

absorption and eventually causes constipation. [5]<br />

This evidence supports the hypothesis that an important etiological<br />

factor of anal fissures is hypothyroidism causing constipation.<br />

Methods<br />

We first identified the male and female patients presenting to the<br />

outpatient department with various lower abdominal complaints like<br />

lower gastrointestinal bleeding, painful defecation, constipation, or<br />

mass descending per rectum. These patients were then diagnosed with<br />

constipation, hemorrhoids, malignancy, fistula, abscess, or fissure in<br />

ano. The fissure in ano patients were further classified as per their age<br />

distribution.<br />

Informed consent for inclusion in the study was obtained. A thyroid<br />

assay was ordered for all the fissure in ano patients who were admitted<br />

for surgical procedures. Patients with TSH values higher than the<br />

reference range or T3/T4 values lower than the reference range were<br />

labeled as hypothyroid.<br />

The prevalence of hypothyroidism is identified in the public population<br />

using previously done studies and compared with the prevalence of<br />

hypothyroidism in our patients with fissure in ano.<br />

TABLE 1: Diagnosis of male patients presenting with lower<br />

gastrointestinal complaints<br />

Constipation 34<br />

Hemorrhoids 43<br />

Malignancy 3<br />

Fistula 11<br />

Abscess 18<br />

Fissure in ano 80<br />

TOTAL 189<br />

Diagnosis of male patients presenting with lower<br />

gastrointestinal complaints<br />

TABLE 2: Age distribution of male patients diagnosed with<br />

fissure in ano<br />

60 years<br />

9%<br />

6%<br />

2<br />

Abscess<br />

Fissure in ano<br />

TOTAL 80<br />

2%<br />

A total of 1497 female patients presented to the surgical OPD during the<br />

study period, of which 127 had lower gastrointestinal complaints.<br />

Result<br />

A total of 3332 patients presented to the Surgical OPD during the study<br />

period, of which 316 presented with lower gastrointestinal complaints.<br />

The incidence of lower gastrointestinal complaints in our surgical OPD<br />

was 9.4%. Of the 316 patients with lower gastrointestinal complaints,<br />

121 were diagnosed with fissure in ano. 38.2% of patients with lower<br />

gastrointestinal complaints and 3.6% of the total number of patients<br />

presenting to the surgical OPD were attributed to fissure in ano.<br />

A total of 1835 male patients presented to the surgical OPD during the<br />

study period, of which 189 had lower gastrointestinal complaints.<br />

Diagnosis of male patients presenting with lower<br />

gastrointestinal complaints<br />

42%<br />

9%<br />

18%<br />

6%<br />

2%<br />

23%<br />

Constipation<br />

Hemorrhoids<br />

Malignancy<br />

Fistula<br />

Abscess<br />

Fissure in ano<br />

CHART 2: Diagnosis of female patients presenting with<br />

lower gastrointestinal complaints<br />

9%<br />

32%<br />

1%<br />

2%<br />

TABLE 3: Diagnosis of female patients presenting with lower<br />

gastrointestinal complaints<br />

23%<br />

Constipation 42<br />

Hemorrhoids 29<br />

Malignancy 2<br />

Fistula 1<br />

Abscess 12<br />

Fissure in ano 41<br />

TOTAL 127<br />

33%<br />

Constipation<br />

Hemorrhoids<br />

Malignancy<br />

Fistula<br />

Abscess<br />

Fissure in ano<br />

GASTROENTEROLOGY TODAY - AUTUMN <strong>2019</strong><br />

9


FEATURE<br />

TABLE 4: Age distribution of female patients diagnosed with<br />

fissure in ano<br />

60 years 1<br />

TOTAL 41<br />

A total of 50 patients with fissure in ano were admitted for surgical<br />

procedures and their thyroid assay was subsequently done. 16<br />

patients had hypothyroidism characterized by increased free TSH<br />

values and low free T3 and free T4 according to the reference<br />

range. The incidence of hypothyroidism in patients with fissure in<br />

ano is 32%.<br />

Discussion<br />

Conclusion<br />

Lower gastrointestinal symptoms form a significant proportion of people<br />

attending the surgical outpatient department out of which one third are<br />

diagnosed with fissure in ano.<br />

The patients present with various types and degrees of symptoms and<br />

complications all of which are distressing.<br />

This positive association can be used to encourage screening of<br />

patients diagnosed with fissure in ano for thyroid derangements. Also<br />

patients diagnosed with hypothyroidism can be advised to manage their<br />

constipation to prevent anal fissures.<br />

Conflict of Interest: None<br />

References<br />

1. McCallion K, Gardiner KR. Progress in the understanding and<br />

treatment of chronic anal fissure. Postgraduate medical journal.<br />

2001 Dec 1;77(914):753-8.<br />

Fissures were more common in the age group of 20 to 40<br />

years with an incidence of 67.5% in males and 82.9% of<br />

females attending the surgical outpatient department with lower<br />

gastrointestinal complaints.<br />

According to a study done by Unnikrishnan et al in eight cities<br />

in India, the overall prevalence of hypothyroidism was 10.95%.<br />

A significantly higher proportion of females with 15.86% as<br />

compared to males with 5.02% were diagnosed. [6] In the present<br />

study, the incidence of hypothyroidism is significantly higher.<br />

In a population-based study done in Cochin on 971 adult<br />

subjects, the prevalence of hypothyroidism was 3.9%. The<br />

prevalence of subclinical hypothyroidism was high in this study<br />

as well with 9.4%. In women, the prevalence was higher(11.4%),<br />

when compared with men (6.2%). [7] Our study has an incidence<br />

of 32% which is higher.<br />

2. Klosterhalfen B, Vogel P, Rixen H, Mittermayer C. Topography of<br />

the inferior rectal artery: a possible cause of chronic, primary anal<br />

fissure. Diseases of the Colon & Rectum. 1989 Jan 1;32(1):43-52.<br />

3. Prohm P, Bönner C. Is manometry essential for surgery of<br />

chronic fissure-in-ano?. Diseases of the colon & rectum. 1995 Jul<br />

1;38(7):735-8.<br />

4. Minguez M, Tomas-Ridocci M, Garcia A, Benages A. Pressure of the<br />

anal canal in patients with hemorrhoids or with anal fissure. Effect<br />

of the topical application of an anesthetic gel. Revista espanola de<br />

enfermedades digestivas: organo oficial de la Sociedad Espanola<br />

de Patologia Digestiva. 1992 Feb;81(2):103-7.<br />

5. Yaylali O, Kirac S, Yilmaz M, Akin F, Yuksel D, Demirkan N,<br />

Akdag B. Does hypothyroidism affect gastrointestinal motility?.<br />

<strong>Gastroenterology</strong> research and practice. 2009;2009.<br />

GASTROENTEROLOGY TODAY - AUTUMN <strong>2019</strong><br />

The prevalence of hypothyroidism in India is 11%, 2% in the<br />

UK and 4·6% in the USA. Coastal cities like Mumbai, Goa, and<br />

Chennai, have a higher prevalence (11·7%) than cities located<br />

inland (9·5%). [8] The present study has a higher incidence of<br />

hypothyroidism.<br />

In a study done by Velayutham et al, 11% of young females in<br />

the south Indian population had elevated TSH levels. [9] In the<br />

present study, the incidence is 32%.<br />

Since the incidence of hypothyroidism in our study is higher than<br />

the prevalence of hypothyroidism in the general population as<br />

documented by multiple studies in the past, we can conclude that<br />

there is a significant association between hypothyroidism and<br />

development of fissure in ano.<br />

6. Unnikrishnan AG, Kalra S, Sahay RK, Bantwal G, John M, Tewari<br />

N. Prevalence of hypothyroidism in adults: An epidemiological<br />

study in eight cities of India. Indian journal of endocrinology and<br />

metabolism. 2013 Jul;17(4):647.<br />

7. Unnikrishnan AG, Menon UV. Thyroid disorders in India: An<br />

epidemiological perspective. Indian journal of endocrinology and<br />

metabolism. 2011 Jul;15(Suppl2):S78.<br />

8. Bagcchi, Sanjeet. “Hypothyroidism in India: more to be done.” The<br />

Lancet Diabetes & Endocrinology 2.10 (2014): 778.<br />

9. Velayutham K, Selvan SS, Unnikrishnan AG. Prevalence of<br />

thyroid dysfunction among young females in a South Indian<br />

population. Indian journal of endocrinology and metabolism. 2015<br />

Nov;19(6):781.<br />

10


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POSTERS<br />

Endoscope reprocessing:<br />

we’re only human<br />

We’re only human was an American movie directed by James Flood and<br />

released in 1935. Even then, there was great interest in shifting from human<br />

work to automated assembly lines. But what does this have to do with the<br />

reprocessing of flexible endoscopes? In my opinion, it is related to today’s<br />

reprocessing problems of these complex medical devices. For decades we<br />

have known that flexible endoscopes – even when cleaned and disinfected -<br />

can be a source of debris, biofilm and thus micro-organisms, leading to serious<br />

infection problems. Just take a look at the headlines about contaminated,<br />

so called ‘superbug’, endoscopes. However, manual reprocessing is still<br />

underestimated and reprocessing staff are only human.<br />

GASTROENTEROLOGY TODAY - AUTUMN <strong>2019</strong><br />

12<br />

The importance of endoscopy<br />

Since the introduction of the first flexible endoscope in<br />

1956 by Basil Hirschowitz and Larry Curtis, the number of<br />

procedures using these devices has increased enormously.<br />

Only in the United States approximately 75 million procedures<br />

were performed in 2017 [idataresearch.com, 28 may 2018].<br />

And it is expected that this number will increase in the next<br />

decades. A procedure with a flexible endoscope has many<br />

advantages compared to traditional procedures and they are<br />

very safe. Of course, like any other procedure, there are also<br />

potential complications like perforation, bleeding, pancreatitis<br />

(as a result of ERCP) or infection. Focusing on the last one,<br />

these infections can originate from the patients own bacterial<br />

flora, or from exogenous flora, transmitted by a previously<br />

used endoscope.<br />

Complex, reusable devices<br />

Flexible endoscopes are complex, reusable medical devices.<br />

During a procedure they can become highly contaminated<br />

with organic materials and bacteria. Studies have showed a<br />

high bacterial contamination inside the channels of sometimes<br />

more than 10^9 CFU per channel (one billion colony forming<br />

units) [Rutala WA, Weber DJ. Reprocessing endoscopes:<br />

United States perspective. J Hosp Infect. Apr 2004;56 Suppl<br />

2: S27-31. Kaczmarek RG et al. Am J Med 1992;92:257-261].<br />

Flexible endoscopes need to be thoroughly reprocessed<br />

between each patient, to guarantee a safe subsequent use.<br />

Simultaneously with the technical development, extensive use<br />

of endoscopes and identified outbreaks due to contaminated<br />

endoscopes, techniques for cleaning and disinfection were<br />

improved. One of the most important innovations in endoscopy<br />

was the introduction of high-level disinfection of endoscopes<br />

[Sivak MV. Gastrointestinal endoscopy: past and future.<br />

GUT. 2006, Aug; 55(8), 1061-1064).<br />

The role of automated endoscope-disinfectors<br />

With the introduction and increased usage of automated<br />

high-level endoscope-disinfectors, practitioners developed<br />

an utopic belief that the problem of contaminated endoscopes<br />

would belong to the past. Now that the reprocessing process<br />

was automated, controlled, and could be retrieved and<br />

validated. Practitioners thought that manual cleaning was not<br />

necessary anymore with these endoscope-disinfectors - which<br />

also contained a cleaning and increased rinsing stage, with<br />

reduced human failures in reprocessing. However, reality was<br />

different: even with the use of these disinfectors, outbreaks<br />

due to contaminated endoscopes kept occurring. Endoscopes<br />

were still not clean enough after reprocessing [Kovaleva, 2013].<br />

This is not a surprise.<br />

Underestimated manual cleaning<br />

With only flushing water with detergent to disinfectant through<br />

the channels, automated endoscope-disinfectors were not<br />

able to remove any debris, biofilm and thus micro-organisms.<br />

Although some endoscope-disinfectors claim a 90% reduction<br />

of debris in the first step inside cleaning [Alfa et al, 2006], the<br />

manual cleaning before automated cleaning and disinfection is<br />

still the most important step [Beilenhoff, ESGE-ESGENA 2018].<br />

Manual brushing and flushing of the endoscope, using the<br />

right procedures and techniques, removes > 90% of all debris,<br />

biofilm and micro-organisms [Chu NS, McAlister D, Antonoplos<br />

PA. 1998. Natural bioburden levels detected on flexible<br />

gastrointestinal endoscopes after clinical use and manual<br />

cleaning. Gastrointest. Endosc. 48:137–142]. The last 10%<br />

can be removed by the automated endoscope-disinfector.<br />

However, in daily practice, the manual cleaning stage is<br />

downgraded to just a simple flush and brush, despite all<br />

reported outbreaks and the detailed IFUs for manual cleaning.<br />

The question is: why?<br />

Time pressure in reprocessing units<br />

Since the number of endoscopic procedures is increasing<br />

enormously, there is a great pressure on the availability<br />

of reprocessed endoscopes. With the high turnover of<br />

endoscopes, time has become the key factor in many<br />

endoscopy wards and reprocessing units. After use,


POSTERS<br />

endoscopes should be available as fast as possible. There is<br />

a continuous pressure to reduce reprocessing times. Every<br />

minute counts. Also in the manual cleaning stage, and even<br />

in the drying stage. Ofstead et al showed that in 45% of<br />

cases key steps in reprocessing are skipped. In less than 50%,<br />

manual cleaning and drying - the two most critical steps - are<br />

performed according to instructions [Ofstead et al. Endoscope<br />

reprocessing methods. A prospective study of human factors<br />

and automation. Gastrointestinal Nursing. 2010; Vol 33. No 4,<br />

pp 304-311]. In reality, only a few minutes are invested in<br />

flushing, brushing, inspection and the leak test, without<br />

following all steps of the reprocessing manual.<br />

Also, it is known that when working under high pressure<br />

mistakes can increase. Of course, we are only human.<br />

75% of the reprocessing staff reported on a time pressure<br />

and non-compliance with guidelines related to reprocessing<br />

as a result [Beilenhoff U et al. Reprocessing in GI Endoscopy:<br />

ESGE-ESGENA Position Statement. Endoscopy 2018; 50].<br />

For decades we have known that time pressure sometimes<br />

leads to reported outbreaks of infection. But what has been<br />

done to reduce the risk? Okay, there were some critical reports,<br />

guidelines were improved and recently an automated, video<br />

controlled, cleaning unit (UltraZonic ® ) was introduced to<br />

increase effectiveness and standardization. Hereby eliminating<br />

human failures as a nice side effect. However, the required<br />

reprocessing is still a point of discussion – especially<br />

amongst managers.<br />

Fingers pointed in the wrong direction<br />

We are all pointing at the manufacturers. They have developed<br />

complex, difficult to clean endoscopes and their reprocessing<br />

manuals are hard to understand and on average more than a<br />

hundred pages long, including over 150 steps. In my opinion<br />

we are turning the world upside down. Of course, flexible<br />

endoscopes are complex devices, and design flaws can lead<br />

to problems, even of infectious origin. However, outbreaks<br />

related to flexible endoscopes are only in 8% related to the<br />

design of flexible endoscopes [Kovaleva, 2012]. It is possible<br />

to clean, disinfect and dry endoscopes adequately following<br />

the manufacturer’s instructions for use (IFUs) at all times.<br />

[Muscarella et al. World J Gastrointestinal Endosc. 2014.<br />

October 16; 6(10): 457-474 ISSN 1948-5190]. But we need<br />

to be willing to invest time, dedicated and qualified personal,<br />

and the right equipment and resources.<br />

Training the human capital<br />

We need to invest in training our personnel continuously.<br />

It is well known that intensified training of endoscopists<br />

(physicians) and nurse endoscopists is a successful way to<br />

improve diagnosis and treatment, which might result in better<br />

patient outcome [UEG, June 2014]. A recent survey shows a<br />

positive effect in training reprocessing staff and regular audits<br />

to ensure compliance to reprocessing guidelines [Beilenhoff U<br />

et al. Reprocessing in GI Endoscopy: ESGE-ESGENA Position<br />

Statement. Endoscopy 2018; 50].<br />

But it is easier said than done: it is remarkable and even<br />

perplexing that we still do not invest enough in continuous<br />

training of the people reprocessing those complex instruments<br />

on a daily basis. Not only to eliminate human failures, but to<br />

improve quality and safety in endoscope reprocessing as well.<br />

Resulting in less risks of exogenous infections due to an<br />

improperly cleaned and disinfected endoscope.<br />

Shift from quantity to quality<br />

I call upon the field, to shift from reprocessing quantity to<br />

quality. Despite all innovations, such as disposable ERCP<br />

tips (Pentax), new drying and storage systems like the<br />

PlasmaTYPHOON, or even upcoming disposable endoscopes,<br />

the human factor will always stay important. Quoting Alibabafounder<br />

Jack Ma ‘Computers have only chips. Humans have<br />

a heart. And it’s the heart in which wisdom is originated’.<br />

It is never too late to invest in human capital, especially when<br />

reprocessing complex medical devices like flexible endoscopes.<br />

Paul J Caesar<br />

(Tjongerschans Hospital, Heerenveen,<br />

the Netherlands) Expert in infection control,<br />

sterile medical devices and reprocessing<br />

flexible endoscopes<br />

GASTROENTEROLOGY TODAY - AUTUMN <strong>2019</strong><br />

13


NEWS<br />

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GASTROENTEROLOGY TODAY - AUTUMN <strong>2019</strong><br />

14<br />

PRESCRIBING INFORMATION: Feraccru 30mg hard<br />

capsules (ferric maltol)<br />

Please refer to the full Summary of Product Characteristics<br />

(SmPC) before prescribing.<br />

Presentation: Red hard capsules. Each capsule contains<br />

30 mg iron (as ferric maltol). Indication: Feraccru is<br />

indicated in adults for the treatment of iron deficiency.<br />

Dosage and Administration: Adults: Feraccru should be<br />

taken orally. The whole capsule should be taken on an<br />

empty stomach (with half a glass of water). The<br />

recommended dose is one capsule twice daily, in the<br />

morning and evening. The absorption of iron is reduced<br />

when Feraccru is taken with food. Treatment duration will<br />

depend on the severity of iron deficiency but generally at<br />

least 12 weeks treatment is required. The treatment should<br />

be continued as long as necessary to replenish the body<br />

iron stores according to blood tests. Elderly: No dose<br />

adjustment is necessary. Children: The safety and efficacy<br />

of Feraccru in children (17 years and under) has not yet<br />

been established. No data are available. Patients with<br />

hepatic or renal impairment: No clinical data is available<br />

in this patient population. Contraindications:<br />

Hypersensitivity to the active substance or to any of the<br />

excipients; Haemochromatosis and other iron overload<br />

syndromes; Patients receiving repeated blood<br />

transfusions. Warnings and precautions: Feraccru should<br />

not be used in patients with inflammatory bowel disease<br />

(IBD) flare or in IBD patients with haemoglobin (Hb) levels<br />


NEWS<br />

‘<br />

The taboo subject of<br />

constipation: undermining<br />

patient’s quality of life and<br />

putting a preventable strain<br />

on NHS<br />

The Bowel Interest Group launches <strong>2019</strong><br />

‘Cost of Constipation’ report<br />

26th July <strong>2019</strong> - Independent<br />

multidisciplinary organisation The Bowel<br />

Interest Group has released its ‘Cost of<br />

Constipation’ report revealing the impact<br />

that the taboo subject of constipation has on<br />

the UK. This latest report not only explores<br />

the significant cost of constipation to the<br />

NHS but highlights the damaging impact on<br />

patient lives.<br />

The report shows that poor bowel health and<br />

chronic constipation, which are debilitating<br />

for hundreds and thousands of people in<br />

the UK, cost the NHS a preventable £71<br />

million in unplanned hospital admissions for<br />

constipation in 2017/18. This cost is likely to<br />

be much higher when GP visits, home visits<br />

and over the counter laxatives are taken into<br />

account. Specifically, the report shows that:<br />

• In 2017/18, 71,430 people with<br />

constipation were admitted to hospital in<br />

England. This is equivalent to 196 per day.<br />

• Close to three quarters of these were<br />

unplanned emergency admissions,<br />

equivalent to 144 per day.<br />

• £91 million was spent on prescription<br />

laxatives in 2017/18.<br />

• The cost of treating constipation in<br />

2017/18 is equivalent to funding 7043<br />

newly-qualified nurses for a year.<br />

• On average, 6.3 people visit a GP about<br />

constipation each week.<br />

The Cost of Constipation report also lays<br />

bare the embarrassment and distress<br />

caused by the condition, revealing that<br />

one in five people are embarrassed to talk<br />

about constipation with their GP, and some<br />

people find themselves unable to leave the<br />

house for social activities. In addition to the<br />

physical problems constipation can cause<br />

such as haemorrhoids, chronic pain and<br />

urinary tract infections, the report highlights<br />

the high incidence of anxiety disorders and<br />

depression in people with constipation.<br />

Dr Benjamin Disney, Consultant<br />

Gastroenterologist, University Hospitals<br />

Coventry and Warwickshire NHS Trust,<br />

comments: “Many people see constipation<br />

as a simple, straightforward, easily treated<br />

condition that does not greatly affect people.<br />

However, from the Cost of Constipation<br />

report and my clinical experience, this is<br />

often not the case, with the condition being<br />

under-reported and often poorly managed,<br />

leading to a significant cost to the NHS and<br />

having a negative impact on patients’ overall<br />

health and quality of life. The Bowel Interest<br />

Group aims to tackle and raise awareness of<br />

the important issue of constipation.”<br />

Patients, clinicians and other interested<br />

parties may download the full report<br />

free of charge by visiting: https://<br />

bowelinterestgroup.co.uk/cost-ofconstipation-report-<strong>2019</strong>-public.<br />

The Complete FIT Solution<br />

Numerous publications now demonstrate the high NPV<br />

performance of faecal immunochemical testing (FIT) with<br />

symptomatic patients for cancer, HRA and IBD.<br />

Alpha Laboratories has partnered with many of the FIT pioneers to<br />

further expand the knowledge of the use of FIT for symptomatic<br />

patients. For example, THE NICE FIT STUDY (www.nicefitstudy.com)<br />

has now generated over 11,500 data sets, doubling the data reviewed<br />

by NICE across 10 studies. With many new publications in print, or<br />

pending publication, confirming the recommendations of NICE DG30,<br />

the application of this test is helping to optimise patient pathways in<br />

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Everything you need to know about FIT:<br />

W: faecal-immunochemical-test.co.uk | E: digestivedx@alphalabs.co.uk<br />

GASTROENTEROLOGY TODAY - AUTUMN <strong>2019</strong><br />

The FIT Solution_Oct_19.indd 1 19/09/<strong>2019</strong> 12:04:56<br />

15


NEWS<br />

Northern Ireland patients<br />

first to use exercise in<br />

overcoming treatment for<br />

deadliest common cancer<br />

Northern Ireland pancreatic cancer<br />

patients will be the first in the UK to trial<br />

an innovative new exercise programme to<br />

aid their recovery from the traumatic 12-<br />

hour operation needed to save their lives,<br />

after researchers from Queen’s University<br />

Belfast were awarded a grant of more than<br />

£100,000 from Pancreatic Cancer UK.<br />

The grant from Pancreatic Cancer UK’s<br />

Research Innovation Fund is the charity’s first<br />

ever investment in a research project based<br />

in Northern Ireland. The charity believes that,<br />

if it is successful, the project has significant<br />

potential to improve the quality of life for<br />

patients who have surgery, an area of research<br />

that has previously been under-developed<br />

because of the urgent need to find new<br />

treatments and improve diagnosis. Pancreatic<br />

cancer has the lowest survival of all common<br />

cancers, with less than seven per cent of<br />

people with the disease in Northern Ireland<br />

living for five years.<br />

Surgery is the only cure for pancreatic cancer<br />

but it can have a traumatic impact on patients.<br />

The procedure involves removing all or part of<br />

the pancreas and making major changes to<br />

the digestive system, meaning patients can<br />

experience serious side effects - including<br />

pain, fatigue and anxiety - in addition to the<br />

effects of chemotherapy. The burden of these<br />

symptoms can damage a patient’s recovery as<br />

well their long-term health and wellbeing.<br />

Researchers will work extensively with local<br />

pancreatic cancer patients who have had<br />

surgery to design bespoke exercise programs<br />

tailored toward managing each individual’s<br />

symptoms. Exercise has previously been<br />

shown to benefit patients with other cancers<br />

such as breast and prostate, but the two-year<br />

study by Queen’s University will be the first<br />

time it has been trialled with those treated for<br />

pancreatic cancer. Patients will be supported<br />

in undertaking resistance and aerobic exercise<br />

at their own pace, alongside post-operative<br />

chemotherapy. It is hoped that a successful<br />

trial in Belfast will see the project expand to<br />

other sites in the UK benefiting more patients.<br />

Dromore, County Down resident Tom<br />

Hawthorne knows all about the impact of the<br />

operation. He was diagnosed with pancreatic<br />

cancer in August 2017 and quickly scheduled<br />

for surgery. He credits cycling with helping<br />

him to overcome the side effects. Tom, 61,<br />

said: “I was told that it was going to be a pretty<br />

tough operation but at that stage I did not fully<br />

grasp what that actually meant. For me, the<br />

operation was totally devastating - it was really<br />

tough, physically and psychologically.<br />

“From my first day out of intensive care I<br />

was determined to give it my best shot after<br />

speaking to my surgeon. From blowing that<br />

little pipe to keep the ball up, to family helping<br />

me around the corridors and friends helping<br />

me to the park, it all helped me so much. Then<br />

eventually getting back on my bike. All this for<br />

me made me so much stronger in every way<br />

and had a massive impact on my recovery.<br />

Not everyone can do it but it’s well worth doing<br />

your best. You will feel the benefit.”<br />

Dr Chris MacDonald, Head of Research<br />

at Pancreatic Cancer UK, said: “Research<br />

into pancreatic cancer has been grossly<br />

underfunded for decades, stifling innovation<br />

and delaying the breakthroughs we so badly<br />

need to see. The potential positive impact of<br />

this project devised by the team at Queen’s<br />

University Belfast is hugely exciting and I am<br />

delighted it is our first-ever funded research in<br />

Northern Ireland.<br />

“While it can be lifesaving, the combination<br />

of such extensive surgery followed by<br />

chemotherapy can take a heavy toll. It may<br />

sound counterintuitive, but exercise could<br />

be key to mitigating many of the symptoms<br />

that affect a patient’s quality of life. We are<br />

determined to explore innovative ideas such<br />

as this one to ensure patients can make the<br />

fullest possible recovery.”<br />

The research at Queen’s University Belfast is<br />

one of six promising new projects to receive a<br />

grant from Pancreatic Cancer UK’s Research<br />

Innovation Fund in <strong>2019</strong>. Grants are intended<br />

to help combat the cycle of underfunding which<br />

has hampered desperately needed progress on<br />

diagnosis, treatment and survival for pancreatic<br />

cancer. By funding cutting-edge projects,<br />

Pancreatic Cancer UK helps researchers take<br />

their work to the next stage of development and<br />

closer to much-needed breakthroughs. Since<br />

its creation Pancreatic Cancer UK’s Research<br />

Innovation Fund has awarded more £2 million to<br />

research projects, which have gone on to attract<br />

more than £14 million of additional funding.<br />

GASTROENTEROLOGY TODAY - AUTUMN <strong>2019</strong><br />

Dr Gillian Prue, Lead Researcher from the<br />

School of Nursing and Midwifery at Queen’s<br />

University Belfast, said: This is a fantastic<br />

opportunity for people with pancreatic cancer<br />

in NI and we are very grateful to Pancreatic<br />

Cancer UK for their support. We hope that by<br />

undertaking a supervised exercise programme<br />

during chemotherapy patients may avoid<br />

an almost inevitable decline in function.<br />

Increasing activity levels may help patients<br />

tolerate chemotherapy treatment and reduce<br />

treatment side effects. This is the first time<br />

a study such as this has been undertaken<br />

in the UK, so we will be working very closely<br />

with our patients to ensure the programme is<br />

achievable and meets their needs.”<br />

16


The only licensed treatment for the<br />

reduction in recurrence of overt<br />

hepatic encephalopathy (OHE) 1<br />

NEWS<br />

At home they<br />

are still at risk;<br />

…TARGAXAN ®<br />

rifaximin-α<br />

reduces the risk<br />

of recurrence<br />

of overt hepatic<br />

encephalopathy. 2<br />

Long-term secondary prophylaxis in hepatic<br />

encephalopathy (HE) 3<br />

UK&IE Prescribing Information: Targaxan 550mg (rifaximin-α)<br />

REFER TO FULL SUMMARY OF PRODUCT CHARACTERISTICS (SmPC)<br />

BEFORE PRESCRIBING<br />

Presentation: Film-coated tablet containing rifaximin 550 mg.<br />

Uses: Targaxan is indicated for the reduction in recurrence of episodes<br />

of overt hepatic encephalopathy in patients ≥ 18 years of age.<br />

Dosage and administration: Adults 18 years of age and over: 550 mg<br />

twice daily, with a glass of water, with or without food for up to 6 months.<br />

Treatment beyond 6 months should be based on risk benefit balance<br />

including those associated with the progression of the patients hepatic<br />

dysfunction. No dosage changes are necessary in the elderly or those<br />

with hepatic insufficiency. Use with caution in patients with renal<br />

impairment.<br />

Contraindications: Contraindicated in hypersensitivity to rifaximin,<br />

rifamycin-derivatives or to any of the excipients and in cases of<br />

intestinal obstruction.<br />

Warnings and precautions for use: The potential association of<br />

rifaximin treatment with Clostridium difficile associated diarrhoea and<br />

pseudomembranous colitis cannot be ruled out. The administration<br />

of rifaximin with other rifamycins is not recommended. Rifaximin<br />

may cause a reddish discolouration of the urine. Use with caution<br />

in patients with severe (Child-Pugh C) hepatic impairment and in<br />

patients with MELD (Model for End-Stage Liver Disease) score > 25.<br />

In hepatic impaired patients, rifaximin may decrease the exposure of<br />

concomitantly administered CYP3A4 substrates (e.g. warfarin,<br />

antiepileptics, antiarrhythmics, oral contraceptives). Both decreases and<br />

increases in international normalized ratio (in some cases with bleeding<br />

events) have been reported in patients maintained on warfarin and<br />

prescribed rifaximin. If co-administration is necessary, the international<br />

normalized ratio should be carefully monitored with the addition or<br />

withdrawal of treatment with rifaximin. Adjustments in the dose of<br />

oral anticoagulants may be necessary to maintain the desired level of<br />

anticoagulation. Ciclosporin may increase the rifaximin Cmax<br />

Pregnancy and lactation: Rifaximin is not recommended during<br />

pregnancy. The benefits of rifaximin treatment should be assessed<br />

against the need to continue breastfeeding.<br />

Side effects: Common effects reported in clinical trials are dizziness,<br />

headache, depression, dyspnoea, upper abdominal pain, abdominal<br />

distension, diarrhoea, nausea, vomiting, ascites, rashes, pruritus, muscle<br />

spasms, arthralgia and peripheral oedema. Other effects that have<br />

been reported include: Clostridial infections, urinary tract infections,<br />

candidiasis, pneumonia cellulitis, upper respiratory tract infection and<br />

rhinitis. Blood disorders (e.g. anaemia, thrombocytopenia). Anaphylactic<br />

reactions, angioedemas, hypersensitivity. Anorexia, hyperkalaemia and<br />

dehydration. Confusion, sleep disorders, balance disorders, convulsions,<br />

hypoesthesia, memory impairment and attention disorders.<br />

Hypotension, hypertension and fainting. Hot flushes. Breathing difficulty,<br />

pleural effusion, COPD. Gastrointestinal disorders and skin reactions.<br />

Liver function test abnormalities. Dysuria, pollakiuria and proteinuria.<br />

Oedema. Pyrexia. INR abnormalities. Prescribers should consult the<br />

SmPC in relation to all adverse reactions.<br />

UNITED KINGDOM<br />

Legal category: POM<br />

Cost: Basic NHS price £259.23 for 56 tablets<br />

Marketing Authorisation holder: Norgine Pharmaceuticals Limited,<br />

Norgine House, Widewater Place, Moorhall Road, Harefield, Uxbridge,<br />

UB9 6NS, UK<br />

Marketing Authorisation number: PL 20011/0020<br />

IRELAND<br />

Legal category: Prescription only<br />

Cost: €262.41 for 56 tablets<br />

Marketing Authorisation holder: Norgine B.V. Hogehilweg 7, 1101 CA<br />

Amsterdam ZO, Netherlands<br />

Marketing Authorisation number: PA 1336/009/001<br />

For further information contact:<br />

Norgine Pharmaceuticals Limited, Norgine House, Moorhall Road,<br />

Harefield, Middlesex UB9 6NS<br />

Telephone: 01895 826 606<br />

E-mail: Medinfo@norgine.com<br />

Ref: UK/XIF5/0119/0477<br />

Date of preparation: January <strong>2019</strong><br />

United Kingdom<br />

Adverse events should be reported. Reporting forms and<br />

information can be found at www.mhra.gov.uk/yellowcard.<br />

Adverse events should also be reported to Medical<br />

Information at Norgine Pharmaceuticals Ltd on:<br />

Tel. +44 (0)1895 826 606<br />

Email Medinfo@norgine.com<br />

Ireland<br />

Healthcare professionals are asked to report any<br />

suspected adverse reactions via HPRA Pharmacovigilance,<br />

Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;<br />

Fax: +353 1 6762517. Website: www.hpra.ie;<br />

E-mail: medsafety@hpra.ie. Adverse events should<br />

also be reported to Medical Information at<br />

Norgine Pharmaceuticals Ltd on: Tel. +44 (0)1895 826 606<br />

Email Medinfo@norgine.com<br />

References:<br />

1. National Institute for Health and Care Excellence.<br />

Rifaximin for preventing episodes of overt hepatic encephalopathy:<br />

appraisal guidance TA337 for rifaximin.<br />

Available from: http://www.nice.org.uk/guidance/ta337<br />

2. TARGAXAN ® 550 Summary of Product Characteristics.<br />

Available for the UK from: https://www.medicines.org.uk/emc<br />

Available for Ireland from: www.medicines.ie<br />

3. Mullen KD, et al. Clin Gastroenterol Hepatol<br />

2014;12(8):1390-97.<br />

Product under licence from Alfasigma S.p.A. TARGAXAN is a<br />

registered trademark of the Alfasigma group of companies, licensed<br />

to the Norgine group of companies. NORGINE and the sail logo are<br />

registered trademarks of the Norgine group of companies.<br />

UK/XIF5/0219/0487<br />

Date of preparation: February <strong>2019</strong>.<br />

GASTROENTEROLOGY TODAY - AUTUMN <strong>2019</strong><br />

17


NEWS<br />

Rising stars of<br />

<strong>Gastroenterology</strong> &<br />

Hepatology honoured at the<br />

<strong>2019</strong> Dr Falk Pharma/Guts<br />

UK Awards<br />

An investigation into why and how normal<br />

colon cells mutate into cancer, how best to<br />

reduce the harm caused by blood borne liver<br />

viruses in prisons and the potential benefits of<br />

faecal microbial transplantation (FMT) in the<br />

treatment of chronic liver disease. These are<br />

just a few of the highly significant research and<br />

clinical projects explored by the ten worthy<br />

winners of the <strong>2019</strong> Dr Falk Pharma UK/Guts<br />

UK Charity Awards. The winners, who included<br />

medical students, junior doctors, nurses and<br />

dietitians were presented with their awards<br />

during a dinner on Tuesday June 18th at the<br />

British Society of <strong>Gastroenterology</strong> (BSG)<br />

Annual Meeting in Glasgow.<br />

Now in their 13th year, the Dr Falk Pharma UK/<br />

Guts UK Charity Awards have become widely<br />

recognised within the gastroenterology and<br />

hepatology community for the support and<br />

endorsement they offer junior doctors starting<br />

out on their careers. Through nurse and<br />

dietitian prizes, the awards also acknowledge<br />

and reward the innovation and dedication that<br />

these HCPs bring to their patients.<br />

Professor Chris Hawkey, President of Guts UK<br />

Charity, who co-presented the ceremony says:<br />

‘These awards have supported numerous<br />

medical students, junior doctors, nurses<br />

and dietitians at crucial early stages in their<br />

careers. These are the most talented health<br />

professionals and leaders of tomorrow and<br />

support at this early stage helps to signal their<br />

potential to them and their peers and foster<br />

self-belief as the bright stars of tomorrow. The<br />

awards continue to be highly competitive and<br />

help to attract the brightest and the best to the<br />

field of UK gastroenterology.<br />

‘Guts UK is delighted to continue its collaboration<br />

with Dr Falk Pharma UK, and the Trustees of<br />

Guts UK greatly value Dr Falk’s clear vision and<br />

ongoing support of this valuable initiative.’<br />

Ms Jaclyn Tan was awarded the Medical Student<br />

Prize for her project focussing on the diagnosis<br />

and management of patients with spontaneous<br />

bacterial peritonitis (SBP), a frequent and severe<br />

complication with a high mortality rate in patients<br />

with cirrhosis and ascites.<br />

‘It is a great honour to be awarded the Dr<br />

Falk/Guts UK Medical Student Prize,’ said Ms<br />

Tan, who will return to take up her 4th year of<br />

medicine at the University College Medical<br />

School in September.<br />

‘This has fuelled my drive to undertake<br />

further work within the discipline, as I strive<br />

to contribute to the scientific community and<br />

apply research findings in the clinical setting to<br />

improve patient care’<br />

Advanced Dietitian in Paediatric<br />

<strong>Gastroenterology</strong>, Ms Isobel Connolly won<br />

the Dietitian Award for her work establishing<br />

a dietetic-led clinic for paediatric patients<br />

with Coeliac Disease. Her Manager, Principle<br />

Paediatric Dietician Nicole Dos Santos explained:<br />

‘This service has improved patient care<br />

significantly by increasing patient access<br />

to follow up and decreasing the number of<br />

appointments patients require, improving<br />

patient attendance and streamlining dietetic<br />

review with blood monitoring.’<br />

Dr Riadh Jazrawi, Medical Director of Dr Falk<br />

Pharma UK and co-presenter of the Awards<br />

commented:<br />

‘This year, as always, we take huge pleasure<br />

in being able to reward and support the talent,<br />

work ethic and passion displayed by these<br />

young medical students and doctors.<br />

‘We sincerely hope that, in doing so, we can<br />

support and encourage them into become<br />

the next generation of hepatologists and<br />

gastroenterologists.<br />

‘We are also delighted to honour the<br />

commitment displayed by our nurse and<br />

dietitian award winners, who often in their own<br />

time, instigate innovative projects that lead to<br />

great benefits for patients.’<br />

GASTROENTEROLOGY TODAY - AUTUMN <strong>2019</strong><br />

18


NEWS<br />

GASTROENTEROLOGY TODAY - AUTUMN <strong>2019</strong><br />

19


NEWS<br />

ARE YOU DOING YOUR BEST<br />

FOR PBC PATIENTS?<br />

Inadequate or intolerant response to UDCA is defined as<br />

ALP >1.67 x ULN (>200 IU/L) and/or bilirubin 2 x ULN 1<br />

PBC expertise is closer<br />

than you think...<br />

Consider referral to 1 of 26<br />

PBC hubs in England or a Liver<br />

Centre comprised of specialist<br />

multidisciplinary teams for<br />

individualised patient treatment<br />

and second-line therapy.<br />

6<br />

3 4<br />

2<br />

1<br />

26<br />

11<br />

32<br />

15<br />

9<br />

7<br />

24<br />

23<br />

16<br />

12<br />

13<br />

25<br />

21 8<br />

14<br />

Find your nearest PBC referral<br />

hub at www.uk-pbc.com/<br />

newtherapiesinpbc/<br />

Find your nearest Liver Centre<br />

at www.britishlivertrust.org.uk/<br />

liver-information/useful-links/<br />

liver-and-transplant-units/<br />

Liver Centres<br />

PBC Hubs<br />

30<br />

33 31<br />

5<br />

20<br />

28<br />

17<br />

29<br />

18<br />

27 19<br />

22<br />

10<br />

1. Aberdeen Royal Infirmary<br />

2. Ninewells Hospital, Dundee<br />

3. Glasgow Royal Infirmary<br />

4. Edinburgh Royal Infirmary<br />

5. University Hospital Wales,<br />

Cardiff<br />

6. Royal Victoria Hospital,<br />

Belfast<br />

7. Aintree Univ Hosp NHS FT<br />

8. Barts Health NHS Trust<br />

9. Bradford Teaching<br />

10. Cambridge Univ Hosp<br />

NHS FT<br />

11. East Lancashire Hosps<br />

NHS Trust<br />

12. Hull & East Yorkshire<br />

NHS Trust<br />

13. King’s College Hosp<br />

NHS FT<br />

14. Imperial College<br />

Healthcare Trust<br />

15. Leeds Teaching Hosp<br />

NHS Trust<br />

16. Manchester University<br />

NHS FT<br />

17. Nottingham Univ Hosp<br />

NHS Trust<br />

18. Oxford Univ Hosps NHS FT<br />

19. Portsmouth Hosps<br />

NHS Trust<br />

20. Royal Devon & Exeter FT<br />

21. Royal Free London NHS FT<br />

22. Royal Surrey County Hosp<br />

NHS FT<br />

23. Royal L’pool/Broadgreen<br />

Univ Trust<br />

24. Sheffield Teaching<br />

Hosp FT<br />

25. St George’s Univ Hosps<br />

NHS FT<br />

26. The Newcastle upon Tyne<br />

Hosps FT<br />

27. Univ Hosp Southampton<br />

NHS FT<br />

28. Univ Hosps Birmingham<br />

NHS FT<br />

29. Univ Hosps Leicester<br />

NHS Trust<br />

30. Univ Hosps Plymouth<br />

NHS Trust<br />

31. University Hosp Bristol<br />

NHS FT<br />

32. York Teaching Hospital<br />

NHS FT<br />

33. Royal Gwent Hospital,<br />

Newport<br />

Find out more information in the BSG guidelines at www.bsg.org.uk/clinical/bsg-guidelines.html<br />

GASTROENTEROLOGY TODAY - AUTUMN <strong>2019</strong><br />

Abbreviated Prescribing Information<br />

OCALIVA ® (obeticholic acid)<br />

(Please refer to the Full Summary of Product Characteristics (SmPC) before prescribing)<br />

Presentation: OCALIVA supplied as film-coated tablets containing<br />

5 mg and 10 mg obeticholic acid. Indication: For the treatment of<br />

primary biliary cholangitis (also known as primary biliary cirrhosis)<br />

in combination with ursodeoxycholic acid (UDCA) in adults with<br />

an inadequate response to UDCA or as monotherapy in adults<br />

unable to tolerate UDCA. Dosage and administration: Oral<br />

administration. Hepatic status must be known before initiating<br />

treatment. In patients with normal or mildly impaired (Child Pugh<br />

Class A) hepatic function, the starting dose is 5 mg once daily.<br />

Based on an assessment of tolerability after 6 months, the dose<br />

should be increased to 10 mg once daily if adequate reduction of<br />

alkaline phosphatase (ALP) and/or total bilirubin have not been<br />

achieved. No dose adjustment of concomitant UDCA is required<br />

in patients receiving obeticholic acid. For cases of severe pruritus,<br />

dose management includes reduction, temporal interruption or<br />

discontinuation for persistent intolerable pruritus; use of bile acid<br />

binding agents or antihistamines (see SmPC). Moderate to Severe<br />

Hepatic Impairment: In patients with Child-Pugh B or C hepatic<br />

impairment, a reduced starting dose of 5mg once weekly is required.<br />

After 3 months, depending on response and tolerability, the starting<br />

dose may be titrated to 5 mg twice weekly and subsequently to<br />

10 mg twice weekly (at least 3 days between doses) if adequate<br />

reductions in ALP and/or total bilirubin have not been achieved.<br />

No dose adjustment required in Child Pugh Class A function. Mild<br />

or moderate renal impairment: No dose adjustments are required.<br />

Paediatric population: No data. Elderly: No dose adjustment<br />

required; limited data exists. Contraindications: Hypersensitivity to<br />

the active substance or any excipients. Complete biliary obstruction.<br />

Special warnings and precautions for use: After initiation, patients<br />

should be monitored for progression of PBC with frequent clinical<br />

and laboratory assessment of those at increased risk of hepatic<br />

decompensation. Dose frequency should be reduced in patients<br />

who progress from Child Pugh A to Child Pugh B or C Class disease.<br />

Serious liver injury and death have been reported in patients with<br />

moderate/severe impairment who did not receive appropriate dose<br />

reduction. Liver-related adverse events have been observed within<br />

the first month of treatment and have included elevations in alanine<br />

amino transferase (ALT), aspartate aminotransferase (AST) and<br />

hepatic decompensation. Interactions: Following co-administration<br />

of warfarin and obeticholic acid, International Normalised Ratio<br />

(INR) should be monitored and the dose of warfarin adjusted, if<br />

needed, to maintain the target INR range. Therapeutic monitoring of<br />

CYP1A2 substrates with narrow therapeutic index (e.g. theophylline<br />

and tizanidine) is recommended. Obeticholic acid should be taken<br />

at least 4-6 hours before or after taking a bile acid binding resin,<br />

or at as great an interval as possible. Fertility, pregnancy and<br />

lactation: Avoid use in pregnancy. Either discontinue breastfeeding<br />

or discontinue/abstain from obeticholic acid therapy<br />

taking into account the benefit of breast-feeding for the child<br />

and the benefit of therapy for the woman. No clinical data on<br />

fertility effects. Undesirable effects: Very common (≥1/10) adverse<br />

reactions were pruritus, fatigue, and abdominal pain and discomfort.<br />

The most common adverse reaction leading to discontinuation was<br />

pruritus. The majority of pruritus occurred within the first month of<br />

treatment and tended to resolve over time with continued dosing.<br />

Other commonly (≥ 1/100 to < 1/10) reported adverse reactions are,<br />

thyroid function abnormality, dizziness, palpitations, oropharyngeal<br />

pain, constipation, eczema, rash, arthralgia, peripheral oedema,<br />

and pyrexia. Please refer to the SmPC for a full list of undesirable<br />

effects. Overdose: Liver-related adverse reactions were reported<br />

with higher than recommended doses of obeticholic acid. Patients<br />

should be carefully observed, and supportive care administered,<br />

as appropriate. Legal category: POM Marketing authorisation<br />

numbers: EU/1/16/1139/001 & 002 Marketing authorisation holder:<br />

Intercept Pharma International Ltd, 31–36 Ormond Quay Upper,<br />

Dublin 7, Ireland Package Quantities and Basic NHS cost: OCALIVA<br />

5 mg and 10 mg £2,384.04 per bottle of 30 tablets. Date of revision:<br />

10th June <strong>2019</strong><br />

Adverse events should be reported. Reporting forms and<br />

information can be found at www.mhra.gov.uk/yellowcard.<br />

Adverse events should also be reported to<br />

Intercept Pharma Ltd on +44 (0)330 100 3694<br />

or email: drugsafety@interceptpharma.com<br />

20<br />

ALP, alkaline phosphatase; PBC, primary biliary cholangitis; UDCA, ursodeoxycholic acid; ULN, upper limit of normal.<br />

1. EASL guidelines. J Hepatol. 2017;67:145–172.<br />

UK-PP-PB-0464 September <strong>2019</strong>


NEWS<br />

Okayama University<br />

research: Early gastric<br />

cancer endoscopic<br />

diagnosis system using<br />

artificial intelligence<br />

(Okayama, 15 July) Researchers at<br />

Okayama University have developed<br />

an early gastric cancer endoscopic<br />

diagnosis system using artificial<br />

intelligence (AI). The details were<br />

presented at the Congress of the Japan<br />

Gastroenterological Endoscopy Society<br />

(JGES), May 31 – June 2, <strong>2019</strong>, Tokyo.<br />

According to data released in 2017 by<br />

Japan’s Ministry of Health, Labor, gastric<br />

cancer ranks third in cancer deaths in<br />

Japan: second in men and fourth in women.<br />

Treatment of early-stage gastric cancer<br />

includes endoscopic surgery (ESD),<br />

which can save the stomach, and surgical<br />

procedures that require gastrectomy.<br />

However, although advances in endoscopic<br />

treatment technology has led to the early<br />

detection of gastric cancer, decisions on<br />

whether to use endoscopy treatment or<br />

surgery mainly depend on how deep the<br />

cancer has invaded the stomach wall.<br />

Furthermore, these decisions are made by<br />

careful examination of endoscopic images<br />

by experienced physicians. At present,<br />

there are many cases where endoscopic<br />

treatment is performed first where surgery<br />

would have been more appropriate and vice<br />

versa.<br />

(Convolutional Neural Network) published<br />

by Google on numerical analysis software<br />

MATLAB.<br />

Next, the researchers used the ResNet,<br />

which is a 152-layer convolutional<br />

neural network, to conduct intramucosal<br />

endoscopic resection among patients<br />

treated for early gastric cancer at Okayama<br />

University Hospital.<br />

Using endoscopic images of 100<br />

cancers (M group) and 50 submucosal<br />

invasion cancers (SM-ESD group) and 50<br />

submucosal invasion cancers (SM-OPE<br />

group) who had undergone surgery from<br />

the beginning, the researchers built the AI<br />

system and verified its diagnostic accuracy.<br />

The diagnostic accuracy of intramucosal<br />

cancer by artificial intelligence diagnostic<br />

system was sensitivity 82.7%, specificity<br />

63.0%, positive predictive value 69.1%,<br />

negative predictive rate 78.4% in image<br />

unit, and sensitivity 82.0% in case unit.<br />

The specificity was 71.0%, the positive<br />

predictive value was 73.9%, and the<br />

negative predictive value was 79.8%.<br />

In addition, the correct diagnosis rate for<br />

deep-seated diagnosis of early gastric<br />

cancer as a combination of intramucosal<br />

cancer and submucosal invasion cancer<br />

was 72.8% in image units and 76.5% in<br />

case units.<br />

Implications of the research<br />

At present, gastroenterological endoscope<br />

medical diagnosis and treatment is based<br />

on experienced practicing physicians<br />

examining images.<br />

As a result, the diagnostic ability of<br />

individual doctors varies, and with increases<br />

in the number of medical services in the<br />

future, there is concern about the possibility<br />

of oversight of cancer and increases in<br />

misdiagnosis. If automatic diagnosis of<br />

digestive tract endoscope images by AI is<br />

realized, then ‘automated diagnosis logic’<br />

will be added to endoscope technology for<br />

real time diagnosis.<br />

Automatic diagnosis will be possible and<br />

it will greatly improve the current status of<br />

relying on the diagnostic ability of individual<br />

endoscopy physicians.<br />

With this background, Professor Yoshiro<br />

Kawahara of the Graduate School of<br />

Medical and Dental Sciences, Okayama<br />

University, and colleagues have developed<br />

artificial intelligence (AI)-based endoscope<br />

for early detection of gastric cancer. These<br />

research results were presented at the 97th<br />

Congress of the Japan Gastroenterological<br />

Endoscopy Society (JGES), May 31 – June<br />

2, <strong>2019</strong>, Tokyo.<br />

First the prototype of the system to obtain<br />

the depth of early gastric cancer was<br />

constructed with GoogLeNet to match<br />

purpose (metastatic learning) by using<br />

the image recognition ability of CNN<br />

GASTROENTEROLOGY TODAY - AUTUMN <strong>2019</strong><br />

21


NEWS<br />

GASTROENTEROLOGY TODAY - AUTUMN <strong>2019</strong><br />

How intestinal bacteria can<br />

cause depression<br />

A research group from Graz is investigating<br />

the complex interaction between the<br />

intestine and the brain. In a project funded<br />

by the Austrian Science Fund FWF, the team<br />

has gained new insights into how intestinal<br />

bacteria, the immune system and obesity<br />

can lead to mental illnesses.<br />

headed by the neuropharmacologist and<br />

neurogastroenterologist Peter Holzer from<br />

Graz was able to identify a number of concrete<br />

factors that can trigger psychological changes<br />

in mice in a recently completed basic-research<br />

project funded by the Austrian Science Fund<br />

It has been known for quite some time that published studies,” says principal investigator<br />

the proverbial “gut feeling” has a real medical Peter Holzer. “In addition to the direct neural<br />

basis. The intestine has its own nervous pathways between intestine and brain, which<br />

system, also known as the “abdominal brain” we have known about for a long time, there are<br />

owing to its size and complexity, and it is many intestinal hormones that carry messages<br />

closely connected to the brain. Processes in to the brain, as well as a huge immune system<br />

the intestine cause changes in the brain and, that releases messenger substances when<br />

conversely, psychological factors influence stimulated. In recent years, the gut microbiota<br />

the intestine. How far this interaction goes and has become an additional factor. This consists<br />

how exactly it works, however, has not yet been of a huge number of monocellular organisms<br />

fully understood. There are indications that the<br />

that also release substances and are believed<br />

intestine may be involved in the development<br />

to play an important role in the body’s<br />

of Gastro<strong>Today</strong>_Jan_<strong>2019</strong>_v4 psychiatric diseases. A research 26/01/<strong>2019</strong> group 09:39 information Page 1 system.” According to Holzer,<br />

many people are<br />

FWF.<br />

Intestine affects the brain<br />

“The connection between the intestinal nervous<br />

system and the brain has been known for a<br />

long time, but the situation has become more<br />

complex if you consider the most recently<br />

familiar with a<br />

strong connection<br />

between brain<br />

and gut. “But we<br />

are not usually<br />

aware of such<br />

an amount of<br />

information<br />

reaching the brain<br />

from the gut. This<br />

information is fed<br />

into brain areas<br />

that are important<br />

for our mood and<br />

emotions.”<br />

Feeling ill<br />

because of<br />

bacteria in the<br />

intestine<br />

Holzer and<br />

his team have<br />

spent five years<br />

investigating<br />

various signalling<br />

pathways<br />

which intestinal<br />

processes can<br />

use to influence<br />

the brain.<br />

One objective<br />

of the project was to clarify how certain<br />

bacteria in the gut alert the immune system<br />

and thus trigger a feeling of illness. “The<br />

immune system learns early on to tolerate<br />

the microorganisms in the gut. That starts<br />

in infancy,” explains Holzer. “When some<br />

substances produced by bacteria penetrate<br />

the intestinal wall, this certainly creates an<br />

immune reaction and, associated with it, a<br />

sense of being ill.” Specifically, he investigated<br />

the so-called “endotoxin lipopolysaccharide”<br />

(LPS), which is released by certain intestinal<br />

bacteria and stimulates the immune system,<br />

giving us a sense of being ill.<br />

“If you suffer an infection with bacteria you will<br />

feel tired, have muscle pain, lose your appetite<br />

and become withdrawn. This is a sensible<br />

reaction of the body, helping it to cope quickly<br />

with the infection,” says the researcher.<br />

“There is evidence, however, that this reaction<br />

could be triggered in humans by intestinal<br />

bacteria, even when there is no infection at<br />

all.” Holzer’s team were able to show that other<br />

substances produced by bacteria, so-called<br />

“peptidoglycans”, enhance the effect of LPS.<br />

“We believe that lipopolysaccharide is only<br />

one of several factors contributing to the<br />

development of mental illness.”<br />

High-fat diet as a risk factor for depression<br />

Holzer sees this physical reaction of “feeling<br />

ill” in the larger context of intestinal influences<br />

on the human psyche, and in particular as a<br />

possible trigger for psychiatric diseases. “We<br />

know from psychiatry and nutritional science<br />

that being overweight increases the risk of<br />

depression and depressive mood disorders.<br />

Moreover, it has also been known for about 15<br />

years that there is a great difference between<br />

the gut microbiota of healthy and severely<br />

overweight people,” Holzer notes. One result<br />

of the project provides concrete information<br />

on how processes in the intestine can trigger<br />

depressive behaviour.<br />

The team subjected mice to a high-fat diet<br />

and analysed their behaviour. In addition to<br />

the chemical changes in the brain that are<br />

associated with depression, they also detected<br />

concomitant behavioural changes. According<br />

to Holzer, it is difficult but not impossible to<br />

detect this in mice. “Depressive people lose<br />

their joy in certain things. This anhedonic, or<br />

listless, behaviour was something we were<br />

able to identify in the mice that were given a<br />

high-fat diet.” Their method was to offer the<br />

mice regular water and sugar water as an<br />

22


NEWS<br />

alternative. Whereas healthy mice prefer sugar<br />

water, the mice in Holzer’s experimental setup<br />

went for it much less often. In the next step,<br />

their gut microbiota was severely depleted<br />

by the administration of antibiotics to find out<br />

whether intestinal microbes contributed to<br />

depressive behaviour after a high-fat diet. The<br />

results are due to be published soon.<br />

Fat hormone as a trigger<br />

Holzer’s team has also identified a possible<br />

signalling pathway to explain how depressive<br />

behaviour can be triggered by a high-fat diet.<br />

The hormone “leptin”, which is released by<br />

fat cells, seems to play a role here. Mice that<br />

are unable to produce this hormone gain the<br />

same amount of weight as other mice when<br />

they eat high-fat foods, but tend not to show<br />

the behaviour associated with depression.<br />

“The role of leptin has not yet been clearly<br />

settled in the literature. We were able to show<br />

at least that leptin is important in this context.”<br />

Holzer suspects that the release of leptin is<br />

linked to short-chain fatty acids produced by<br />

microorganisms in the intestine from fibre-rich<br />

food. The microbiota of the intestine therefore<br />

also seems to play an important role in the<br />

context of depression induced by obesity.<br />

Personal details<br />

Peter Holzer is Professor of Experimental<br />

Neurogastroenterology at the Medical<br />

University of Graz and Head of the Research<br />

Unit for Translational Neurogastroenterology.<br />

For three decades his research has<br />

focussed on the communication between the<br />

gastrointestinal tract and the brain.<br />

Publications<br />

Hassan AM, Mancano G, Kashofer K, Fröhlich<br />

EE, Matak A, Mayerhofer R, Reichmann F,<br />

Olivares M, Neyrinck AM, Delzenne NM, Claus<br />

SP, Holzer P.: High-fat diet induces depressionlike<br />

behaviour in mice associated with changes<br />

in microbiome, neuropeptide Y, and brain<br />

metabolome, in: Nutritional Neuroscience 2018<br />

Fröhlich EE, Farzi A, Mayerhofer R, Reichmann<br />

F, Jacan A, Wagner B, Zinser E, Bordag N,<br />

Magnes C, Fröhlich E, Kashofer K, Gorkiewicz<br />

G, Holzer P.: Cognitive impairment by<br />

antibiotic-induced gut dysbiosis: analysis of<br />

gut microbiota-brain communication, in: Brain,<br />

Behaviour and Immunity 56, 2016<br />

Farzi A, Reichmann F, Meinitzer A, Mayerhofer<br />

R, Jain P, Hassan AM, Fröhlich EE, Wagner<br />

K, Painsipp E, Rinner B, Holzer P.: Synergistic<br />

effects of NOD1 or NOD2 and TLR4 activation<br />

on mouse sickness behavior in relation to<br />

immune and brain activity markers, in: Brain,<br />

Behaviour and Immunity 44, 2015<br />

Inflammatory Bowel Disease<br />

- first Annual Report on<br />

the Use of Biologics in<br />

IBD, published by the IBD<br />

Registry<br />

The IBD Registry, one of the largest clinical<br />

registries in Europe for Inflammatory Bowel<br />

Diseases, has launched its first Annual<br />

Report on the Use of Biologic Therapies in<br />

England & Wales.<br />

The Registry, a not-for-profit company, is<br />

responsible for running the National Audit<br />

of Biological Therapies in IBD, targeted at a<br />

group of diseases which affect around half a<br />

million people in the UK.<br />

The purpose of the report is to consolidate in<br />

one place annual changes and trends across<br />

a basket of key performance indicators used<br />

in the Biological Therapies Audit in IBD and is<br />

based on a dataset from 73 participating IBD<br />

treatment centres in<br />

England Wales.<br />

The report includes<br />

the cumulative results<br />

up to January <strong>2019</strong><br />

from April 2016 when<br />

the Registry assumed<br />

the role of supporting<br />

the National Audit<br />

of Biological<br />

Therapies from the<br />

Royal College of<br />

Physicians.<br />

It is expected the<br />

year-on-year changes<br />

will be primarily<br />

of interest to IBD<br />

clinicians but also<br />

possibly to some<br />

patients, industry,<br />

healthcare managers<br />

and others involved in<br />

IBD services.<br />

Dr Stuart Bloom,<br />

Registry Medical<br />

Director, said, “This<br />

is our first annual<br />

report on biologic therapies, and we hope<br />

that it gives a sense of how clinical and data<br />

management in IBD has been changing for<br />

the better, both more widely and over many<br />

years. For example, vital information used<br />

by clinicians to treat patients is increasingly<br />

captured for the Registry’s database at the<br />

point of care rather than retrospectively, with<br />

the associated benefits of greater accuracy of<br />

information on a patient’s disease experience.<br />

“The report also makes references to a larger<br />

clinical dataset captured by the Registry which<br />

aims to provide a picture of the care received<br />

by people with IBD over time. We hope the<br />

results and commentary prove of interest to<br />

clinicians and others involved in managing<br />

IBD, as well as to the 500,000 people living<br />

with these diseases.<br />

“Finally, the IBD Registry would like to thank<br />

all those who have contributed to making this<br />

report a reality, above all our partner IBD clinical<br />

teams around the country who provided the<br />

information on which the report is based.”<br />

The report will be available on the IBD Registry<br />

website as a PDF at www.ibdregistry.org.uk<br />

Join our ‘Sock It to Sepsis’ campaign to<br />

raise funds for vital research into sepsis.<br />

Bring family & friends together and hold a stripy<br />

or red and white themed event. Register today<br />

for a Free fundraising pack.<br />

Email: info@sepsisresearch.org.uk<br />

Call: 07379 989 191<br />

Together we can Sock it to Sepsis.<br />

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www.sepsisresearch.org.uk<br />

Sepsis Research (FEAT) SCIO is a registered charity<br />

SC049399 and relies on the generosity of legacies and<br />

donations to help fund research and awareness of sepsis<br />

GASTROENTEROLOGY TODAY - AUTUMN <strong>2019</strong><br />

23


From Norgine, the company that brought you<br />

MOVIPREP<br />

NEWS<br />

® (Macrogol 3350, sodium sulphate, ascorbic acid, sodium ascorbate and electrolytes)<br />

The first 1 litre PEG bowel preparation 1-3<br />

Improve the efficacy<br />

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p=0.014)<br />

Safety profile comparable to<br />

MOVIPREP® 1,4-6<br />

Powder for Oral Solution<br />

PEG 3350, Sodium Ascorbate, Sodium<br />

Sulfate, Ascorbic Acid, Sodium Chloride,<br />

and Potassium Chloride<br />

UK AND IE PRESCRIBING INFORMATION: Plenvu powder for oral solution<br />

(Macrogol 3350 + Sodium ascorbate + Ascorbic acid + Sodium sulfate<br />

anhydrous + Potassium chloride + Sodium chloride)<br />

Please refer to the full Summary of Product Characteristics (SmPC)<br />

before prescribing.<br />

Presentation: Plenvu powder for oral solution is administered in two doses.<br />

Dose one is made up of 1 sachet containing: macrogol 3350 100g, sodium sulfate<br />

anhydrous 9g, sodium chloride 2g, potassium chloride 1g. Dose 2 is made up of<br />

2 sachets (A and B). Sachet A contains: macrogol 3350 40g, sodium chloride 3.2g,<br />

potassium chloride 1.2g. Sachet B contains: sodium ascorbate 48.11g, ascorbic<br />

acid 7.54g.<br />

Indication: For bowel cleansing in adults, prior to any procedure requiring a clean<br />

bowel.<br />

Dosage and administration: For oral use. Adults and elderly: A course of<br />

treatment consists of two separate non-identical 500ml doses of Plenvu. At least<br />

500ml of additional clear fluid must be taken with each dose. Treatment can be<br />

taken according to a two-day or one-day dosing schedule. Two-day dosing schedule:<br />

First dose taken the evening before the procedure. Second dose in the early morning<br />

of the day of the procedure. Morning only dosing schedule: Both doses taken the<br />

morning of the procedure. The two doses should be separated by a minimum of<br />

1 hour. Day before dosing schedule: Both doses taken the evening before the<br />

procedure. The two doses should be separated by a minimum of 1 hour. No solid<br />

food should be taken from the start of the course of treatment until after the clinical<br />

procedure. Consumption of all fluids should be stopped at least 2 hours prior to a<br />

procedure under general anaesthesia or 1 hour prior to a procedure without general<br />

anaesthesia. Children: Not recommended for use in children below 18 years of age.<br />

Patients with renal or hepatic impairment: No special dosage adjustment is<br />

deemed necessary in patients with mild to moderate renal or hepatic impairment.<br />

GASTROENTEROLOGY TODAY - AUTUMN <strong>2019</strong><br />

Patients should be advised to allow adequate time after bowel movements have<br />

subsided to travel to the clinical unit.<br />

Contraindications: Hypersensitivity to the active substances or to any of the<br />

excipients, gastrointestinal obstruction or perforation, ileus, disorders of gastric<br />

emptying (gastroparesis, gastric retention), phenylketonuria, glucose-6-phosphate<br />

dehydrogenase deficiency, toxic megacolon.<br />

Warnings and precautions: The fluid content of reconstituted Plenvu does not<br />

replace regular fluid intake. Adequate fluid intake must be maintained. As with<br />

other macrogol containing products, allergic reactions including rash, urticaria,<br />

pruritus, angioedema and anaphylaxis are a possibility. Caution should be used<br />

with administration to frail or debilitated patients, in patients with impaired gag<br />

reflex, with the possibility of regurgitation or aspiration, or with diminished levels<br />

of consciousness, severe renal impairment, cardiac failure (grade III or IV of NYHA),<br />

those at risk of arrhythmia, dehydration or severe acute inflammatory bowel disease.<br />

24<br />

In debilitated fragile patients, patients with poor health, those with clinically significant<br />

renal impairment, arrhythmia and those at risk of electrolyte imbalance, the physician<br />

should consider performing a baseline and post-treatment electrolyte, renal function<br />

test and ECG as appropriate.<br />

Any suspected dehydration should be corrected for before use of Plenvu.<br />

There have been rare reports of serious arrhythmias including atrial fibrillation<br />

associated with the use of ionic osmotic laxatives for bowel preparation, predominantly<br />

in patients with underlying cardiac risk factors and electrolyte disturbance.<br />

If patients develop any symptoms indicating arrhythmia or shifts of fluid/electrolytes<br />

during or after treatment, plasma electrolytes should be measured, ECG monitored<br />

and any abnormality treated appropriately.<br />

If patients experience severe bloating, abdominal distension, or abdominal pain,<br />

administration should be slowed or temporarily discontinued until the symptoms<br />

subside.<br />

The sodium content, 458.5mmol (10.5g), should be taken into consideration for<br />

patients on a controlled sodium diet. The potassium content, 29.4mmol (1.1g), should<br />

be taken into consideration by patients with reduced kidney function or those on a<br />

controlled potassium diet.<br />

Interactions: Medicinal products taken orally within one hour of starting colonic<br />

lavage with Plenvu may be flushed from the gastrointestinal tract unabsorbed. The<br />

therapeutic effect of drugs with a narrow therapeutic index or short half-life may be<br />

particularly affected.<br />

Fertility, pregnancy and lactation: There are no data on the effects of Plenvu on<br />

fertility in humans. There were no effects on fertility in studies in male and female rats.<br />

It is preferable to avoid the use of Plenvu during pregnancy.<br />

It is unknown whether Plenvu active ingredients/metabolites are excreted in human<br />

milk. A risk to the newborns/infants cannot be excluded. A decision must be made<br />

whether to discontinue breast-feeding or to abstain from Plenvu therapy taking into<br />

account the benefit of breast-feeding for the child and the benefit of therapy for<br />

the woman.<br />

Effects on ability to drive and use machines: Plenvu has no influence on the<br />

ability to drive and use machines.<br />

Undesirable effects: Diarrhoea is an expected outcome.<br />

Common: vomiting, nausea, dehydration. Uncommon: abdominal distension,<br />

anorectal discomfort, abdominal pain, drug hypersensitivity, headache, migraine,<br />

somnolence, thirst, fatigue, asthenia, chills, pains, aches, palpitation, sinus<br />

tachycardia, transient increase in blood pressure, hot flush, transient increase in<br />

liver enzymes, hypernatraemia, hypercalcaemia, hypophosphataemia, hypokalaemia,<br />

decreased bicarbonate, anion gap increased/ decreased, hyperosmolar state.<br />

Refer to the SmPC for a full list and frequency of adverse events.<br />

UNITED KINGDOM:<br />

Price and pack sizes: £12.43 (3 sachet)<br />

Legal category: Pharmacy medicine<br />

MA Number: PL 20011/0040<br />

MA Holder: Norgine Pharmaceuticals Limited, Norgine House, Widewater Place,<br />

Moorhall Road, Harefield, Uxbridge, UB9 6NS, UK<br />

IRELAND<br />

Legal category: Product subject to medical prescription which may be renewed<br />

MA Number: PA 1336/005/001<br />

MA Holder: Norgine BV, Hogehilweg 7, 1101CA Amsterdam ZO, The Netherlands<br />

Additional information is available on request or in the SmPC. For<br />

further information contact: Norgine Pharmaceuticals Limited, Norgine<br />

House, Moorhall Road, Harefield, Middlesex, United Kingdom UB9 6NS. Telephone:<br />

+44(0)1895 826606. Email: medinfo@norgine.com<br />

Date of preparation: March <strong>2019</strong><br />

Company reference: UK/PLV/0319/0147<br />

United Kingdom<br />

Adverse events should be reported. Reporting<br />

forms and information can be found at<br />

www.mhra.gov.uk/yellowcard. Adverse events should<br />

also be reported to Norgine Pharmaceuticals Ltd on:<br />

Tel: +44 (0)1895 826 606 Email: medinfo@norgine.com<br />

References: 1. Bisschops R, et al. Endoscopy 2018; doi: 10.1055/a-0638-8125. 2. Schreiber S, et al. Endoscopy 2018; doi: 10.1055/a-0639-5070. 3. DeMicco MP, et al. Gastrointest Endosc 2018; doi: 10.1016/j.gie.2017.07.047. 4. PLENVU ® UK Summary of Product<br />

Characteristics. October 2018. 5. MOVIPREP ® UK Summary of Product Characteristics. September 2018. 6. MOVIPREP ® Orange UK Summary of Product Characteristics. August 2017.<br />

UK/PLV/0919/0180<br />

Date of preparation: September <strong>2019</strong><br />

Ireland<br />

Healthcare professionals are asked to report<br />

any suspected adverse reactions via HPRA<br />

Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel:<br />

+353 1 6764971; Fax: +353 1 6762517.<br />

Website: www.hpra.ie; E-mail: medsafety@hpra.ie.<br />

Adverse events should also be reported to Norgine<br />

Pharmaceuticals Ltd on:<br />

Tel: +44 (0)1895 826 606 Email: medinfo@norgine.com


NEWS<br />

88mm x 247mm (PI) CMYK<br />

UK AND IE PRESCRIBING INFORMATION: Moviprep and Moviprep Orange (Macrogol 3350,<br />

sodium sulfate anhydrous, ascorbic acid, sodium ascorbate, sodium chloride and potassium<br />

chloride)<br />

PLEASE REFER TO THE FULL SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) BEFORE<br />

PRESCRIBING.<br />

Presentation: Powder for oral solution contained in two separate sachets, A and B. Sachet A contains<br />

macrogol 3350 100g; sodium sulfate anhydrous 7.5g; sodium chloride 2.691g and potassium chloride<br />

1.015g. Sachet B contains ascorbic acid 4.7g and sodium ascorbate 5.9g. Uses: Bowel cleansing prior<br />

to any clinical procedure requiring a clean bowel. Dosage and administration: For oral use. Adults<br />

and Older People: A course of treatment consists of two litres of Moviprep / Moviprep Orange. A litre<br />

consists of one sachet A and one sachet B dissolved together in water to make one litre of solution.<br />

The reconstituted solution should be drunk over a period of one to two hours. This process should<br />

be repeated with a second litre to complete the course. A further litre of clear fluid is recommended<br />

during the course of treatment.This course of treatment can be taken either as divided or as single<br />

doses and timing is dependent on whether the clinical procedure is conducted with or without<br />

general anaesthesia as specified below: For procedures conducted under general anaesthesia:<br />

1. Divided doses: one litre in the evening before and one litre in the early morning of the day of the<br />

clinical procedure. Ensure consumption of Moviprep / Moviprep Orange as well as any other clear<br />

fluids has finished at least two hours before the start of the clinical procedure. 2. Single dose: two<br />

litres in the evening before the clinical procedure or two litres in the morning of the clinical procedure.<br />

Ensure consumption of Moviprep / Moviprep Orange as well as any other clear fluids has finished<br />

at least two hours before the start of the clinical procedure. For procedures conducted without<br />

general anaesthesia: 1. Divided doses: one litre in the evening before and one litre in the early<br />

morning of the day of the clinical procedure. Ensure consumption of Moviprep / Moviprep Orange as<br />

well as any other clear fluids has finished at least one hour before the start of the clinical procedure.<br />

2. Single dose: two litres in the evening before the clinical procedure or two litres in the morning of<br />

the clinical procedure. Ensure consumption of Moviprep / Moviprep Orange has finished at least two<br />

hours before the start of the clinical procedure. Ensure consumption of any clear fluids has finished<br />

at least one hour before the clinical procedure. Patients should be advised to allow for appropriate<br />

time to travel to the colonoscopy unit. No solid food should be taken from the start of the course<br />

of treatment until after the clinical procedure. Children: Not recommended below 18 years of age.<br />

Contraindications: Known or suspected hypersensitivity to any of the ingredients, gastrointestinal<br />

obstruction or perforation, disorders of gastric emptying, ileus, phenylketonuria, glucose-6-phosphate<br />

dehydrogenase deficiency, toxic megacolon which complicates very severe inflammatory conditions of<br />

the intestinal tract including Crohn’s disease and ulcerative colitis. Do not use in unconscious patients.<br />

Warnings and precautions: Diarrhoea is an expected effect. Administer with caution to fragile<br />

patients in poor health or patients with serious clinical impairment such as impaired gag reflex, or with<br />

a tendency to aspiration or regurgitation, impaired consciousness, severe renal insufficiency (creatinine<br />

clearance


NEWS<br />

Rare Disease Collaborative<br />

Network for non-responsive<br />

and refractory coeliac disease<br />

By Dr Heidi Urwin Coeliac UK Research<br />

Manager.<br />

Do you have patients diagnosed with coeliac<br />

disease who have ongoing symptoms<br />

despite a gluten free diet? Specialist teams<br />

led by Prof David Sanders in Sheffield and Dr<br />

Jeremy Woodward in Cambridge, have been<br />

approved by the NHS for a Rare Disease<br />

Collaborative Network (RDCN) to provide<br />

support with the diagnosis and care of those<br />

difficult cases of non responsive (NRCD) or<br />

refractory coeliac disease (RCD).<br />

The RDCN will provide facilities for a national<br />

registry for patients with refractory coeliac<br />

disease, a reference diagnostic pathway and<br />

will share experience to improve understanding<br />

and management of this condition.<br />

For the majority of people diagnosed with<br />

coeliac disease, lifelong adherence to a strict<br />

gluten free diet results in clinical and histological<br />

remission. However, up to 30% of people with<br />

coeliac disease may have ongoing symptoms<br />

and or laboratory abnormalities, despite six to<br />

12 months treatment with a gluten free diet.<br />

When NRCD is suspected the original<br />

diagnosis of coeliac disease needs to be<br />

confirmed, followed by repeat gastroscopy<br />

with duodenal biopsies.<br />

Adherence to a gluten free diet varies from 42 to<br />

91% and the most common cause of ongoing<br />

symptoms will be due to gluten exposure<br />

(inadvertent or purposeful). Other causes of<br />

ongoing symptoms may be due to “super<br />

sensitivity”, slow response to treatment, or other<br />

pathologies eg microscopic colitis, pancreatic<br />

insufficiency, Giardiasis, hyperthyroidism.<br />

Patients may broadly fit into one of four groups<br />

depending on the absence or presence of<br />

persisting symptoms and villous atrophy:<br />

Persisting<br />

symptoms<br />

Normal duodenal<br />

histology<br />

Persisting villous<br />

atrophy<br />

Group 1 Group 2<br />

No symptoms Group 3 Group 4<br />

• Group 1, consider other causes of ongoing<br />

symptoms such as functional disorders,<br />

small intestinal bacterial overgrowth (SIBO),<br />

fructose or lactose intolerance.<br />

• Group 2, having excluded ongoing exposure<br />

to gluten, super sensitivity or a slow<br />

response to treatment, consider RCD.<br />

• Group 3, discharge to primary care and<br />

offer annual review in line with NICE NG20.<br />

• Group 4, discuss and explain ongoing<br />

inflammation and the potential risk of long term<br />

complications, consider further dietetic support.<br />

Refractory coeliac disease is rare and<br />

reported to affect between 0.3 to 4.0% of<br />

patients with coeliac disease. It’s also likely<br />

to be over diagnosed due to the difficulties<br />

in differentiating between ongoing gluten<br />

exposure, “super sensitivity”, slow responders<br />

and true RCD.<br />

There are two types of RCD, type 1 and type<br />

2, which differ in presentation, diagnosis<br />

and mortality. Detailed analysis of cell<br />

populations in the duodenal mucosa using<br />

immunohistochemistry and flow cytometric<br />

analysis is required on fresh biopsy samples,<br />

services which are offered via the specialist<br />

centres in Cambridge and Sheffield.<br />

GASTROENTEROLOGY TODAY - AUTUMN <strong>2019</strong><br />

26


NEWS<br />

Patients with RCD type 2 have an aberrant<br />

population of intestinal intraepithelial<br />

lymphocytes (IELs) that lack the usual<br />

expression of CD3 and CD8 on the cell<br />

surface but do express intracellular CD3.<br />

The phenotype of this IEL subset is present<br />

in the healthy population, uncomplicated<br />

coeliac disease and RCD type 1, but at<br />

lower frequencies to that found in RCD type<br />

2. Therefore, clonality testing alone is not<br />

an adequate indicator of RCD type 2, which<br />

requires quantification of the aberrant IEL<br />

subset within the small intestine.<br />

What is the NHS England’s Rare<br />

Diseases Collaborative Network (or<br />

RDCN) for (Non-Responsive and)<br />

Refractory Coeliac Disease?<br />

Sheffield and Cambridge have been<br />

approved as NHS England’s Rare<br />

Diseases Collaborative Network (or RDCN)<br />

for (Non-Responsive and) Refractory<br />

Coeliac Disease. NHS England has also<br />

recognised Sheffield as the lead centre<br />

and Cambridge as the member centre for<br />

this NHS E collaborative disease network.<br />

Clinicians who have cases of suspected<br />

refractory coeliac disease can contact<br />

david.sanders@sth.nhs.uk or Jeremy.<br />

woodward@addenbrookes.nhs.uk. These<br />

two centres will provide clinical support at<br />

the level that the referring clinician would<br />

wish. This can be by reviewing notes,<br />

histological review, telephone consultation<br />

(with patient or clinician) or by seeing the<br />

patient and assessing small bowel biopsy<br />

for monoclonal lymphocyte population, as<br />

well as endoscopic intervention (capsule<br />

endoscopy or enteroscopy). This ensures<br />

a comprehensive assessment which then<br />

leads to discussions about therapeutic<br />

options. Therapeutic intervention can<br />

again be provided by the RDCN or<br />

the referring site. The most important<br />

issue is to ensure that patients have a<br />

standardised care and that the RDCN<br />

can support colleagues in a collaborative<br />

manner. The RDCN will also create a<br />

National Register to provide prospective<br />

data on such patients, analogous to Small<br />

Bowel Transplantation. This may allow<br />

consideration for novel treatments such as<br />

Interleukin-15 or stem cell transplantation<br />

The prognosis of RCD type 2 is poor with<br />

a five year survival of around 50%, largely<br />

accounted for by progression to enteropathy<br />

associated T-cell lymphoma (EATL) in 33%<br />

– 67% of cases. In contrast, while RCD type<br />

1 can progress to EATL, this is rare and the<br />

corresponding five year survival is > 90%.<br />

Transformation to EATL carries a very poor<br />

prognosis with the majority dying within 8<br />

months of diagnosis and a five year survival of<br />

only around 10%.<br />

Clinicians who suspect they have any cases<br />

of refractory coeliac disease can visit the<br />

Coeliac UK website for further information<br />

www.coeliac.org.uk/RCD and contact david.<br />

sanders@sth.nhs.uk or Jeremy.woodward@<br />

addenbrookes.nhs.uk<br />

Reference:<br />

Baggus EMR, Hadjivassiliou M, Cross S et<br />

al. How to manage adult coeliac disease:<br />

perspective from the NHS England Rare<br />

Diseases Collaborative Network for Non-<br />

Responsive and Refractory Coeliac Disease.<br />

Frontline <strong>Gastroenterology</strong> <strong>2019</strong>; 0: 1-8. doi<br />

10.1136/flgastro-<strong>2019</strong>-101191<br />

Record breaking number<br />

of children hospitalised for<br />

eating disorders<br />

Highest number of girls age 13-17<br />

admitted for anorexia as experts warn<br />

parents of social media and celebrity<br />

idolisation<br />

Public Health England has released its<br />

report showing the trends in numbers of<br />

hospital admissions as a result of eating<br />

disorders in young people across England,<br />

revealing that there were more admissions<br />

in 2017/18 than in any of the preceding<br />

years.<br />

There were 2,196 hospital admissions<br />

for eating disorder of children and young<br />

people aged 10 to 24 years in 2017/18.<br />

2,006 - an overwhelming 91%- of these<br />

were of girls, and 1,326 of these were of<br />

girls aged 13 to 17 years.<br />

The report breaks the number of hospital<br />

admissions down by specific age and<br />

gender, and shows that across all ages,<br />

more girls are admitted to hospital than<br />

boys.<br />

Admissions for girls aged just 10 years old<br />

have increased by 146%, from 13 in 2013/14<br />

to 32 last year and for 12 year old girls,<br />

by 93% (from 60 to 116 in the same time<br />

period).<br />

The report states that although bulimia is<br />

more common among children and young<br />

people, it is anorexia which accounts for the<br />

larger proportion of hospital admissions,<br />

fueling concern from leading addiction<br />

treatment experts at UKAT.<br />

“Eating disorders in young people and<br />

children in particular is extremely concerning<br />

because they’re more likely to develop<br />

extensive physical and psychiatric problems<br />

in the long term as a result of their eating<br />

disorder” suggests UKAT’s Group Treatment<br />

Lead, Nuno Albuquerque, who has vast<br />

experience of treating eating disorders.<br />

He continues; “Unlike most other addictions<br />

and disorders, the treatment cannot centre<br />

around abstinence, because we need to<br />

eat to live. Instead treatment is focused on<br />

finding a balance in the relationship between<br />

the person and food. For most, overcoming<br />

eating disorders developed at such a young<br />

age is an ongoing process, and for some, will<br />

be something they live with- under controlled<br />

behaviours learned from treatment- forever.”<br />

UKAT has also revealed that last year, they<br />

admitted more people for eating disorders<br />

than ever before, and that this year, they’re<br />

taking on average around 5 enquiries a day<br />

from concerned parents; double what they<br />

were receiving last year. They run a specialist<br />

eating disorder treatment facility called<br />

Banbury Lodge (www.banburylodge.com) in<br />

Oxfordshire.<br />

Public Health England’s report also raises<br />

concern about hospital admissions in young<br />

boys, showing that back in 2013/14, only 1<br />

10 year old boy was admitted to hospital but<br />

in 2017/18, there were 9 and for 14 year old<br />

boys, 14 were admitted in 2013/14 which has<br />

risen by 178% to 39 in 2017/18.<br />

Nuno concludes; “We believe that social<br />

media and celebrity idolisation has a lot to<br />

do with the rise in eating disorders stemming<br />

from body image issues, but there’s also<br />

a much deeper societal issue with children<br />

experiencing the deficit of attachment from<br />

parents.”<br />

GASTROENTEROLOGY TODAY - AUTUMN <strong>2019</strong><br />

27


POSTERS<br />

COLITIS ON CT – DOES THIS MEAN<br />

Ramakrishnan S, Veglio-Taylor E, Ta<br />

Department of <strong>Gastroenterology</strong>, Barnet Hospital, Royal Fre<br />

GASTROENTEROLOGY TODAY - AUTUMN <strong>2019</strong><br />

28<br />

BACKGROUND:<br />

Cross sectional imaging is commonly used to assess the<br />

abdomen for a variety of symptoms. Colitis reported on CT has<br />

become a frequent indication for lower gastrointestinal<br />

endoscopy. The outcomes of performing colonoscopy for<br />

radiology reported colitis is not clearly known.<br />

METHODS:<br />

Retrospective single centre study of patients referred for<br />

colonoscopy with the indication ‘abnormal imaging.’<br />

Data collected from all endoscopies between 12 month period<br />

at Barnet General Hospital (September 2017 to August 2018).<br />

Exclusion criteria:<br />

1) Modality other than CT/CTVC<br />

2) Overt colonic polyp/mass on CT<br />

Analysis performed using chi-square and student T-test.<br />

Fig.1 – Radiological evidence of colitis<br />

249 patients (183 CT (73.5%), 66 C<br />

(41.8%)) or local lymph nodes (37 (<br />

RESULTS:<br />

colonoscopy for CT evidence o<br />

(87.6%)), fat stranding (88 (35.<br />

Median time from CT to endoscop<br />

56.5).<br />

53 (21.3%) patients of the 249 wh<br />

had completely normal lower GI en<br />

uncomplicated diverticulosis, 11<br />

(8.0%) haemorrhoids and 37 (14.9%<br />

20 patients (8.0%) had endoscop<br />

(6%) histological evidence of coliti<br />

10 patients (4%) had confirmed I<br />

(4 Ulcerative colitis, 6 Crohn’s dise<br />

Fig.2 - Reported CT findings as indic<br />

NUMBER OF PATIENTS<br />

250<br />

200<br />

150<br />

100<br />

50<br />

0<br />

Mural Thickening<br />

Fat Stranding<br />

Inflammati<br />

L<br />

CT FINDING


POSTERS<br />

INFLAMMATORY BOWEL DISEASE?<br />

riq Z, King J, Patel RN, Besherdas K.<br />

e London NHS Foundation Trust, London, United Kingdom.<br />

on<br />

TVC (26.5%)) underwent a<br />

f mural thickening (218<br />

3%)), inflammation (104<br />

14.9%)).<br />

y was 33 days (IQR 12.5 –<br />

o underwent investigation<br />

doscopy. 111 (44.6%) had<br />

(4.4%) diverticulitis, 20<br />

) colorectal polyps.<br />

ic evidence of colitis; 14<br />

s.<br />

BD at 6 months follow up<br />

ase).<br />

ation for Colonoscopy<br />

ocal Lymph Nodes<br />

Fig.3 - Comparison of endoscopic diagnosis according to<br />

CT features and blood results<br />

CONCLUSIONS:<br />

Normal Colitis Malignancy *p value<br />

(n=53) (n=20) (n=21)<br />

Age, mean 63.6 54.4 69.5


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