Weight-Loss Endoscopy Trial: A Multicenter, Randomized, Controlled Trial Comparing Weight Loss in Endoscopically Implanted Duodenal-Jejunal Bypass Liners versus Intragastric Balloons versus a Sham Procedure

Abstract

Introduction: Obesity is associated with reduced life expectancy and various comorbidities. Surgical interventions are effective but accompanied by the 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 versus DJBL versus 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. The 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: Thirty-three patients were randomized. Recruitment has to be stopped suddenly in after the DJBL device lost its CE mark in Europe. In all, 11 patients received DJBL, 15 IB, and 7 were allocated to the sham group. Blinding was feasible in all patients. Weight decreased from baseline until explantation (DJBL: 129.4 ± 28.3 kg to 107.4 ± 16.7 kg; IB: 118.3 ± 22.8 kg to 107.4 ± 25.7 kg; sham: 134.6 ± 18.0 kg to 131.2 ± 14.3 kg), but patients regained weight almost to the baseline level 12 months after explantation. Only 1 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.

Keywords: Bypass liner; Diabetes; Endoscopy; Intragastric balloon; Obesity; Weight loss.

Fig. 1.

The progress of patients in the WET trial is depicted. Two patients were randomized to the liner group on November 9 and 10, 2017. With the retraction of the CE mark for the EndoBarrier^® (GI Dynamics, Boston, USA) on November 14, it was no longer legally permitted to implant the device. To provide these 2 patients’ medical treatment and allow them to remain in the trial, a balloon was implanted. For the purposes of the analysis of this trial (and in the flowchart), they are treated as balloon patients. WET, Weight-loss Endoscopy Trial.

Fig. 2.

a Mean percentage weight loss over time is shown by the randomization group from a mixed model using imputed data. Times were shifted slightly according to the group to avoid overlapping. b Proportion of patients with successful weight loss (>10%), where whiskers represent 95% CI.