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

如果保守治疗无效，内镜治疗肥胖是减肥手术的一种可行且可逆的替代方法。最古老和评价最好的内镜治疗是胃内球囊，它模仿胃袖。另一方面，尚未充分研究的新型空肠-空肠旁路内衬是一种内窥镜植入器械，已被批准用于治疗肥胖患者的2型糖尿病，并模拟胃旁路。植入任何一种器械后，患者体重减轻。但到目前为止，还没有随机试验比较这些设备，无论是减肥还是代谢改善。此外，有证据表明，假干预可以导致相当大的，也许是相当的体重减轻。然而，数据有限且不一致，因此在将成功归因于内窥镜器械之前，有必要重新评价假手术。因此，我们将进行一项随机试验，比较假内窥镜与胃内球囊和空肠-空肠旁路内衬治疗肥胖症。这是一项多中心、随机、对照、患者和评估者盲法疗效试验，包括两个干预组和一个假对照组，我们计划随机分配150例患者。主要疗效结局是移除后12个月体重成功减轻（± 10%），关键次要结局是移除后12个月体重变化百分比、合并症减少和生活质量改善。

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.