A Multicenter, Randomized Efficacy Study Of The EndoBarrier..

A Multicenter, Randomized Efficacy Study Of The EndoBarrier..

Background: The endoscopically positioned duodenal-jejunal bypass sleeve or EndoBarrier Gastrointestinal Liner has been designed to achieve weight reduction in morbidly obese patients. We survey on the first European experience with this product. Methods: A multicenter, randomized scientific trial was performed. Forty-one patients were included and 30 underwent sleeve implantation. Eleven patients served as an eating plan control group. All patients adopted the same low-calorie diet during the research period. The goal of the scholarly study was to determine the safety and efficacy of the device.

Results: Twenty-six devices were effectively implanted. In 4 patients, implantation cannot be achieved. Four devices were explanted prior to the initial protocol end point because of migration (1), dislocation of the anchor (1), sleeve obstruction (1), and constant epigastric pain (1). The rest of the patients all completed the scholarly study. Mean procedure time was 35 minutes (range: 12-102 minutes) for an effective implantation and 17 minutes (range: 5-99 minutes) for explantation.

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There were no method related adverse events. During the research period the 26 duodenal-jejunal bypass sleeve patients (100%) experienced at least one adverse event, week after implantation mainly stomach pain and nausea during the first. Initial mean body mass index (BMI, kg/m2) was 48.9 and 47.4 kg/m2 for the device and control patients, respectively.

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