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

一项多中心、随机、对照试验，比较内镜下植入十二指肠空肠旁路衬管与胃内气球与假手术的减肥效果

• 批准号: 276689665
• 负责人: Professor Dr. Albrecht Hoffmeister
• 金额: --
• 依托单位: Klinik und Poliklinik für Gastroenterologie
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 财政年份: 2016
• 资助国家: 德国
• 起止时间: 2015-12-31 至 2020-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/276689665?language=en
• 关键词: multi; centred; randomized; controlled; trial

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.

如果保守治疗无效，内窥镜治疗肥胖是一种可行且可逆的替代减肥手术的方法。最古老和评价最好的内窥镜治疗是胃内气囊，它模仿胃套。另一方面，新的十二指肠-空肠旁路衬垫是一种内镜下植入的装置，它被批准用于治疗肥胖患者的2型糖尿病，模拟胃旁路。在植入任何一种装置后，患者体重都有所下降。但到目前为止，还没有随机试验对这些设备进行比较，无论是减肥还是改善代谢。此外，有证据表明，虚假干预可以导致相当大的体重减轻。然而，数据有限且不一致，因此有必要在将成功归因于内窥镜装置之前重新评估假手术。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十二指肠-空肠旁路衬垫治疗肥胖的效果。这是一项多中心、随机、对照、患者和评估者盲法疗效试验，有两个干预组和一个假对照组。我们计划随机抽取150名患者。主要疗效指标是术后12个月体重成功减轻（10%），主要次要指标是术后12个月体重变化百分比、合并症减少和生活质量改善。