Supplementary Material for: Weight-loss Endoscopy Trial (WET): a multi-center, randomized, controlled trial comparing weight loss in endoscopically implanted duodenal-jejunal bypass liners vs. intragastric balloons vs. a sham procedure

Introduction: Obesity is associated with reduced life expectancy and various comorbidities. Surgical interventions are effective but accompanied by risk of serious complications. Less invasive endoscopic procedures mainly comprise the intragastric balloon (IB) and the duodenal-jejunal bypass liner (DJBL). A randomized, sham-controlled study comparing both procedures has not been undertaken so far.
Methods: We performed a randomized, patient- and assessor-blinded, controlled trial comparing weight loss in IB vs. DJBL vs. a sham procedure (2:2:1 ratio). Patients with a BMI > 35 kg/m2 or > 30 with obesity-related comorbidities were included. The IB was removed after 6 months and the DJBL after 12 months. Main objective was successful weight loss (>10% from baseline) 12 months after explantation of the devices. Secondary outcomes were changes in comorbidities, quality of life and complications.
Results: 33 patients were randomized. Recruitment has to be stopped suddenly in after the DJBL device lost its CE mark in Europe. 11 patients received DJBL, 15 IB and 7 were allocated to sham group. Blinding was feasible in all patients. Weight decreased from baseline until explantation (DJBL: 129.4±28.3kg to 107.4±16.7kg; IB: 118.3±22.8kg to 107.4±25.7kg; sham: 134.6±18.0kg to 131.2±14.3kg) but patients regained weight almost to baseline level 12 months after explantation. Only one patient in IB group reached the primary endpoint. Severe device-related complications were very rare.
Conclusion: Endoscopic bariatric procedures failed to achieve effective weight loss 12 months after explantation of the devices. The results of this trial need to be interpreted with caution due to its early termination.

引言：肥胖与预期寿命缩短及多种合并症密切相关。外科减重干预虽疗效确切，但伴随严重并发症风险。微创内镜减重术式主要包括胃内球囊（intragastric balloon, IB）与十二指肠-空肠旁路衬垫（duodenal-jejunal bypass liner, DJBL），目前尚无对比这两种术式的随机假对照研究问世。
方法：本研究开展了一项随机、受试者与评估者双盲的对照试验，对比IB、DJBL与假手术组的减重效果，分组比例为2:2:1。纳入标准为体重指数（Body Mass Index, BMI）＞35 kg/m²，或BMI＞30 kg/m²且伴有肥胖相关合并症的患者。IB于置入6个月后取出，DJBL则于置入12个月后取出。主要研究终点为装置取出后12个月时达到有效减重（较基线体重下降＞10%）。次要结局指标包括合并症变化、生活质量评分与并发症发生情况。
结果：共随机纳入33例患者。因DJBL装置在欧洲的CE认证失效，研究不得不提前终止招募。其中11例接受DJBL治疗，15例接受IB治疗，7例被分配至假手术组。所有患者均顺利实现双盲。从基线至装置取出前，三组患者体重均呈下降趋势（DJBL组：129.4±28.3kg 降至107.4±16.7kg；IB组：118.3±22.8kg 降至107.4±25.7kg；假手术组：134.6±18.0kg 降至131.2±14.3kg），但装置取出后12个月，患者体重几乎回升至基线水平。仅IB组有1例患者达到主要研究终点。与装置相关的严重并发症发生率极低。
结论：内镜减重术式在装置取出后12个月时未能实现持续有效减重。鉴于本研究提前终止，对其结果的解读需持谨慎态度。