Open label, prospective, randomized controlled trial of endoscopic duodenal jejunal bypass sleeve versus low calorie diet for weight loss.

Background: The duodenal jejunal bypass sleeve (DJBS) has been shown to achieve a completely endoscopic duodenal exclusion without the need for stapling or anastomosis. This report consists of the first randomized controlled trial for weight loss. Methods: In a 12-week, open label, prospective, randomized study, patients received either a low fat diet and the DJBS or a low fat diet control (no device). Twenty-five patients were implanted with the device and 13 received the control. The two groups were demographically similar with a mean starting BMI of 42. Both groups received identical counseling at baseline only which consisted of a low calorie diet, exercise guidelines and behavior modification advice. No additional counseling occurred in either group. Measurements included starting and monthly body weight and serum blood tests. The device group also had a plain abdominal film post implant, monthly and a 4-week post explant EGD. Results: Twenty device (80%) patients maintained the DJBS without a significant adverse event for the 12-week duration. At 12 weeks, the mean excess weight loss was 22% and 5% for the device and control groups, respectively (p

Session: Podium Presentation

Program Number: S010

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