Gastroenterology Today Autumn 2019
Gastroenterology Today Autumn 2019
Gastroenterology Today Autumn 2019
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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 />
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Other medical staff - £18.00 inc. postage<br />
Non-medical Individuals - £24.00 inc. postage<br />
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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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For the treatment of adults with iron deficiency (ID) 1<br />
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 />
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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 />
cut the volume<br />
vs MOVIPREP ®1<br />
PLENVU® PM/AM dosing was<br />
superior to MOVIPREP® in the per<br />
protocol population (successful<br />
overall cleansing 97.3% vs 92.2%,<br />
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
COMPANY NEWS<br />
CANTEL CANEXIS INTEGRATED WORKFLOW<br />
SOLUTION & LYNGSOE SYSTEMS X-TRACKING<br />
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GASTROENTEROLOGY TODAY - AUTUMN <strong>2019</strong><br />
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Contact Cantel at:<br />
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30
COMPANY NEWS<br />
GASTROENTEROLOGY TODAY - AUTUMN <strong>2019</strong><br />
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