EndoBarrier®: a Safe and Effective Novel Treatment for Obesity and Type 2 Diabetes?

BACKGROUND AND AIMS: Obesity associated with diabetes mellitus is a significant worldwide problem associated with considerable health care costs. Whilst surgical intervention is effective, it is invasive, costly and associated with complications. This study aims to evaluate the safety and efficacy of the EndoBarrier®, a duodenal-jejunal sleeve bypass as an alternative treatment of diabetes mellitus in obese patients. MATERIALS AND METHODS: This was a multi-centre, non-randomised trial recruiting obese patients with type 2 diabetes from three sites in the UK. Eligible participants had a BMI of 30-50 kg/m2 and HbA1c levels of 7.5-10%. The study comprised a 12-month period with the EndoBarrier® inserted and a 6-month follow-up period after it had been explanted. The primary study outcomes were weight, BMI, HbA1c levels and fasting insulin and glucose levels. RESULTS: Forty-five patients were recruited and 31 patients (69%) completed the 12-month study period. Significant reductions in weight (95%CI 0.62-29.38; p < 0.05) and BMI (95%CI 1.1-8.7; p < 0.005) were documented 12 months after device insertion. The mean HbA1c was significantly reduced (95%CI 0.1-1.6; p < 0.05) after the device insertion period and reductions in metabolic parameters (fasting insulin and glucose levels) were also documented during the study. Adverse events were also assessed in all patients, the vast majority of which were reported as mild. CONCLUSIONS: The EndoBarrier® appears to be a safe and effective treatment strategy in overweight patients with poor glycaemic control despite medical therapy, or in those who are eligible but decline bariatric surgery.

Mesalazine-induced myocarditis: a case report.

BACKGROUND: Myocarditis is a rare complication of therapy with mesalazine, a drug widely prescribed in the treatment of inflammatory bowel disease. CASE PRESENTATION: We report a case of myocarditis occurring in a 49-year-old British man 10 days following initiation of mesalazine therapy for treatment of ulcerative colitis. He presented with troponin-positive chest pain, and the diagnosis of myocarditis was confirmed on the basis of cardiac magnetic resonance imaging, which showed subepicardial delayed gadolinium enhancement in the basal to middle inferior and inferolateral segments of the heart. The patient's symptoms and condition improved upon stopping mesalazine, and he made a full recovery. CONCLUSIONS: Mesalazine-induced myocarditis may be more common than first appreciated and is potentially fatal. Therefore, it is imperative that clinicians be aware of this potentially life-threatening adverse effect of mesalazine therapy and warn patients to seek urgent medical attention if cardiac symptoms arise.

Case-based discussion: perceptions of feedback.

BACKGROUND: Over recent years there has been a trend towards developing high-quality assessments to assess a doctor's performance in the workplace. Case-based discussion (CbD) is a form of workplace-based assessment that has the potential to provide feedback to trainees on their performance or management of a specific case. The aim of this study was to explore how CbDs are perceived and implemented in practice amongst a UK cohort of medical trainees. METHODS: This study involved 78 medical trainees at a UK hospital completing a questionnaire rating their last CbD experience, including the duration spent receiving feedback, whether it was pre-planned or ad hoc and how they responded to the feedback received. Focus groups were conducted involving 12 trainees to discuss common themes on feedback arising from the questionnaire, and thematic analysis was carried out following these discussions. RESULTS: Only 19 per cent of assessments were pre-planned and the average duration of assessments was 6-10 minutes, with feedback lasting less than 5 minutes. A total of 76 per cent of trainees responded to the feedback they received by completing self-directed learning or by addressing the specific action points arising from the feedback. The focus groups highlighted the barriers to incorporating these assessments into everyday practice, including appreciating the time constraints and the importance of trainer engagement in the assessment process. The aim of this study was to explore how CbDs are perceived and implemented in practice CONCLUSION: This study demonstrates that most trainees appreciate the educational value of CbDs, but more emphasis and training is required in planning these assessments and in providing feedback that is both specific and actionable.

A randomised controlled trial of a duodenal-jejunal bypass sleeve device (EndoBarrier) compared with standard medical therapy for the management of obese subjects with type 2 diabetes mellitus.

INTRODUCTION: The prevalence of obesity and obesity-related diseases, including type 2 diabetes mellitus (T2DM), is increasing. Exclusion of the foregut, as occurs in Roux-en-Y gastric bypass, has a key role in the metabolic improvements that occur following bariatric surgery, which are independent of weight loss. Endoscopically placed duodenal-jejunal bypass sleeve devices, such as the EndoBarrier (GI Dynamics, Lexington, Massachusetts, USA), have been designed to create an impermeable barrier between chyme exiting the stomach and the mucosa of the duodenum and proximal jejunum. The non-surgical and reversible nature of these devices represents an attractive therapeutic option for patients with obesity and T2DM by potentially improving glycaemic control and reducing their weight. METHODS AND ANALYSIS: In this multicentre, randomised, controlled, non-blinded trial, male and female patients aged 18-65 years with a body mass index 30-50 kg/m2 and inadequately controlled T2DM on oral antihyperglycaemic medications (glycosylated haemoglobin (HbA1c) 58-97 mmol/mol) will be randomised in a 1:1 ratio to receive either the EndoBarrier device (n=80) for 12 months or conventional medical therapy, diet and exercise (n=80). The primary outcome measure will be a reduction in HbA1c by 20% at 12 months. Secondary outcome measures will include percentage weight loss, change in cardiovascular risk factors and medications, quality of life, cost, quality-adjusted life years accrued and adverse events. Three additional subgroups will investigate the mechanisms behind the effect of the EndoBarrier device, looking at changes in gut hormones, metabolites, bile acids, microbiome, food hedonics and preferences, taste, brain reward system responses to food, eating and addictive behaviours, body fat content, insulin sensitivity, and intestinal tissue gene expression. TRIAL REGISTRATION NUMBER: ISRCTN30845205, ClinicalTrials.gov Identifier NCT02459561.

Safe sedation practices among gastroenterology registrars: do we need more training?

Endoscopy training is a central component of gastroenterology training for the vast majority of UK trainees, and integral to this is the practice of safe sedation. The majority of endoscopic procedures are performed with the patient under conscious sedation with a benzodiazepine, often combined with an opioid. Little data exists on the practice of sedation among gastroenterology trainees, including their degree of knowledge of the common sedation agents used and their actions. Using both an online and paper-based questionnaire, we surveyed current gastroenterology speciality trainees (ST) in the UK and received 78 responses giving a response rate of 10%. Fifty-one per cent of the trainees did not receive structured training in safe sedation, despite national guidelines advising this to be an essential part of the training programme, and 92% felt a structured sedation course would be beneficial. We also identified some gaps in trainees' knowledge of the action of sedation agents. We propose that a formal training session in sedation or an e-learning module could be incorporated as part of a deanery or trust induction for gastroenterology trainees and kept under regular review.

Consent in the endoscopy department.

The demand for endoscopic procedures continues to increase and is likely to continue to do so for the foreseeable future. Alongside elective diagnostic procedures, the number of complex and therapeutic procedures is increasing. It is therefore vital that the consent process is comprehensive, and high standards in consenting patients are maintained. Consent is defined as a patient's agreement to treatment or an intervention proposed by a health professional. Careful patient selection is required when proposing endoscopic procedures with an appreciation of the risks and complications that are involved. This paper addresses the various components of gaining informed consent and the legal issues surrounding this process. Additionally, this article reviews legislation and focuses upon specific instances where further considerations have to be made; in a patient who lacks capacity, in children, in percutaneous endoscopic gastrostomy and in the patient who is a Jehovah's Witness.