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ENDOBARRIER (R) : A SAFE AND EFFECTIVE NOVEL TREATMENT FOR OBESITY AND TYPE 2 DIABETES?

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Title: ENDOBARRIER (R) : A SAFE AND EFFECTIVE NOVEL TREATMENT FOR OBESITY AND TYPE 2 DIABETES?
Authors: Mohanaruban, A
Patel, N
Ashrafian, H
Stoenchev, K
Le Roux, C
Penney, N
Kelly, J
Byrne, J
Hopkins, J
Mason, J
Teare, J
Item Type: Conference Paper
Abstract: Introduction Obesity is a modern pandemic. One of the major complications of obesity is the development of diabetes which leads to considerable mortality, morbidity and enormous health care costs.1 The EndoBarrier is an endoscopically implantable duodenal-jejunal sleeve bypass (DJSB); anchored in the duodenum, preventing ingested food from coming into contact with the proximal intestine and induces weight loss and improvement in glycaemic control. The aim of this prospective study was to assess the safety and efficacy of the EndoBarrier in obese patients with type 2 diabetes. Method This was a non-randomised study conducted at three investigational sites (Southampton, London, and Manchester) over an 18 month period with clinical and biochemical assessments carried out at 3 monthly intervals. The device was implanted for 12 months with 6 months follow up. All patients were obese with poorly controlled diabetes. Adverse events were recorded and statistical analysis was performed. Results A total of 45 subjects were enrolled into the study At 12 months following implant: 1) HbA1c significantly reduced from baseline at 0.8% below the mean at baseline (95% CI 0.1–1.6; p<0.05). 2) Mean weight loss was 15 kg (95% CI 0.62–29.38; p<0.05) 3) BMI was reduced by 4.9kg/m2 (95% CI 1.1–8.7; p<0.005). 14 patients withdrew from the study, 6 required premature EndoBarrier removal. Of these, only 2 patients presented with device related complications (device migration and gastrointestinal bleeding), the others withdrew due to unrelated medical adverse events. Conclusion The EndoBarrier appears to be a safe and effective treatment strategy in those who are overweight and have poor glycaemic control despite medical therapy, or in those who are eligible but decline bariatric surgery. Larger randomised controlled trials with longer follow-up periods post-explant of the device need to be performed to investigate the device’s effects on long term glycaemic control and weight.
Issue Date: 1-Jul-2017
Date of Acceptance: 1-Jun-2017
URI: http://hdl.handle.net/10044/1/62224
DOI: https://dx.doi.org/10.1136/gutjnl-2017-314472.400
ISSN: 0017-5749
Publisher: BMJ PUBLISHING GROUP
Journal / Book Title: GUT
Volume: 66
Issue: Suppl 2
Copyright Statement: © 2018 The Author(s). Open Access. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http:// creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appro- priate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
Sponsor/Funder: National Institute for Health Research
Funder's Grant Number: 12/10/04
Conference Name: Annual General Meeting of the British-Society-of-Gastroenterology (BSG)
Keywords: Science & Technology
Life Sciences & Biomedicine
Gastroenterology & Hepatology
1103 Clinical Sciences
1114 Paediatrics And Reproductive Medicine
Publication Status: Published
Start Date: 2017-06-19
Finish Date: 2017-06-22
Conference Place: Manchester, ENGLAND
Online Publication Date: 2017-06-17
Appears in Collections:Department of Surgery and Cancer