A multi-centred, randomized, controlled trial comparing weight loss in endoscopically implanted duodenal-jejunal bypass liner vs intragastric balloons vs a sham procedure

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Endoscopic treatment of obesity constitutes a viable and reversible alternative to bariatric surgery if conservative treatment proves ineffective. The oldest and best evaluated endoscopic therapy is the intragastric balloon, which mimics the gastric sleeve. On the other hand, the new and not yet well studied duodenal-jejunal bypass liner is an endoscopically implanted device, which is approved for the therapy of type 2 diabetes in obese patients and mimics a gastric bypass. After implantation of either device, patients lose weight. But until now, no randomized trial has compared these devices, neither for weight loss nor metabolic improvement. Furthermore, evidence suggests that sham interventions can lead to considerable and perhaps comparable weight loss. However, data are limited and inconsistent and it is thus necessary to re-evaluate sham procedures before attributing successes to the endoscopic devices alone. We shall therefore perform a randomized trial comparing a sham endoscopy with the intragastric balloon and duodenal-jejunal bypass liner for the treatment of obesity. This is a multi-centred, randomized, controlled, patient and assessor blinded efficacy trial with two intervention arms and a sham control arm. We plan to randomize 150 patients. Primary efficacy outcome is successful weight loss (¿ 10%) 12 months after removal and key secondary outcomes are percentage change in weight 12 months after removal, reduction of co-morbidities and improvement in quality of life.