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EndoBarrier®: a Safe and Effective Novel Treatment for Obesity and Type 2 Diabetes?
Patel, N, Mohanaruban, A, Ashrafian, H, Le Roux, C, Byrne, J, Mason, J, Hopkins, J, Kelly, J, Teare, J
Obesity surgery. 2018;(7):1980-1989
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Abstract
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.
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The effect of the endoscopic duodenal-jejunal bypass liner on obesity and type 2 diabetes mellitus, a multicenter randomized controlled trial.
Koehestanie, P, de Jonge, C, Berends, FJ, Janssen, IM, Bouvy, ND, Greve, JW
Annals of surgery. 2014;(6):984-92
Abstract
OBJECTIVE Investigate the safety and efficacy of 6 months' duodenal-jejunal bypass liner (DJBL) treatment in comparison with dietary intervention for obesity and type 2 diabetes mellitus (T2DM). BACKGROUND The DJBL is a bariatric procedure involving an impermeable sleeve that is delivered endoscopically in the proximal intestine. This procedure not only is less invasive than conventional surgical techniques but also has beneficial effects on obesity and T2DM. METHODS A multicenter randomized controlled trial was conducted. Seventy-seven patients with obesity and T2DM were included. Thirty-eight patients were randomized to 6 months' DJBL treatment in combination with dietary intervention (34 successfully implanted, 31 completed the study), 39 patients received only dietary intervention (controls, 35 completed the study). Total study duration for both groups was 12 months, including 6 months of post-DJBL removal follow-up. RESULTS After 6 months, just before DJBL removal, the DJBL group had lost 32.0% [22.0%-46.7%] of their excess weight versus 16.4% [4.1%-34.6%] in the control group (P < 0.05). Glycated hemoglobin A1c levels improved to 7.0% [6.4%-7.5%] in the DJBL group and to 7.9% [6.6%-8.3%] in the control group (P < 0.05). In addition, 85.3% of DJBL patients showed decreased postprandial glucose excursions versus 48.7% of control patients (P < 0.05). At 12 months, excess weight loss of the DJBL group was 19.8% [10.6%-45.0%] versus 11.7% [1.4%-25.4%] in the control group (P < 0.05). HbA1c was 7.3% [6.6%-8.0%] versus 8.0% [6.8%-8.8%], DJBL versus control respectively (P = ns). CONCLUSIONS The DJBL is a safe and effective alternative to invasive bariatric procedures. Six months of DJBL treatment combined with diet leads to superior weight loss and improvement of T2DM when compared with diet alone.
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A multicenter survey of the management after gastric endoscopic submucosal dissection related to postoperative bleeding.
Goto, O, Fujishiro, M, Oda, I, Kakushima, N, Yamamoto, Y, Tsuji, Y, Ohata, K, Fujiwara, T, Fujiwara, J, Ishii, N, et al
Digestive diseases and sciences. 2012;(2):435-9
Abstract
BACKGROUND AND AIMS Bleeding is a major complication after gastric endoscopic submucosal dissection (ESD). An evidence-based strategy for postoperative care related to delayed bleeding is required. We conducted a multicenter survey to assess the current status of management after gastric ESD. METHODS A total of 1,814 gastric epithelial neoplasms in 2009 at ten tertiary referral centers were enrolled. The current status of the management after gastric ESD (use of an antisecretory drug, food intake, and second-look endoscopy) at participating hospitals was assessed. Furthermore, the rate of post-ESD bleeding and the differences in each parameter were retrospectively analyzed. RESULTS Postoperative bleeding occurred in 100 cases (5.5%), which included 62 cases of bleeding within 24 h after ESD. In all of the hospitals, proton pump inhibitors (PPIs) were used. The median administration period was 56 days (range 14-60 days). Food intake was resumed from postoperative day (POD) 1 in 4 hospitals and from POD 2 in 6 hospitals. Second-look endoscopy was performed for almost all cases, fewer cases, and rarely or none in 6, 2, and 2 hospitals, respectively. The day of second-look endoscopy varied among hospitals. There was no statistical relationship between the postoperative bleeding rate and the differences in these three parameters. CONCLUSIONS Post-ESD management (duration of PPI use, resumption of food intake, and performance of second-look endoscopy) varied among the medical centers; thus, randomized controlled trials are required for an optimal strategy after gastric ESD.
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Usefulness and safety of 0.4% sodium hyaluronate solution as a submucosal fluid "cushion" in endoscopic resection for gastric neoplasms: a prospective multicenter trial.
Yamamoto, H, Yahagi, N, Oyama, T, Gotoda, T, Doi, T, Hirasaki, S, Shimoda, T, Sugano, K, Tajiri, H, Takekoshi, T, et al
Gastrointestinal endoscopy. 2008;(6):830-9
Abstract
BACKGROUND Sodium hyaluronate (SH) solution has been used for submucosal injection in endoscopic resection to create a long-lasting submucosal fluid "cushion." OBJECTIVES Our purpose was to assess the usefulness and safety of 0.4% SH solution in endoscopic resection. DESIGN A prospective multicenter randomized controlled trial. SETTING Six referral hospitals in Japan. PATIENTS One hundred forty patients with 5- to 20-mm gastric intramucosal neoplastic lesions. INTERVENTIONS Patients were randomized into 0.4% SH and control groups. Endoscopic resection was performed with 0.4% SH or normal saline solution for submucosal injection. PRIMARY OUTCOME MEASURE The usefulness of 0.4% SH solution was assessed by en bloc complete resection and the formation and maintenance of mucosal lesion-lifting during endoscopic resection. SECONDARY OUTCOME MEASURES (1) steepness of mucosal lesion lifting, (2) complications, (3) time required for mucosal resection, (4) volume of submucosal injection solution, and (5) ease of mucosal resection. Safety was assessed by analyzing adverse events during the study period. RESULTS The usefulness rate was significantly higher for the 0.4% SH group (88.4%, 61/69) than for the control group (58.6%, 41/70). As secondary outcome measures, significant intergroup differences (P < .001) were noted for (1) steepness of mucosal lesion lifting, (2) volume of submucosal injection solution, and (3) ease of mucosal resection. No serious adverse events were encountered in either group. LIMITATIONS Lack of blinding. Safety was not a powered outcome measure. CONCLUSIONS Using 0.4% SH as a submucosal injection solution in endoscopic resection enabled the formation and maintenance of sufficient mucosal lesion lifting for gastric intramucosal lesions, reducing the need for additional injections and simplifying mucosal resection. Use of 0.4% SH thus simplifies the complicated procedures involved in endoscopic resection.