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

Marcus Hollenbach; Jürgen Feisthammel; Christiane Prettin; Felix Gundling; Wolfgang Schepp; Jürgen Stein; David Petroff; Albrecht Hoffmeister

doi:10.1159/000539816

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

Digestion. 2024 Jun 17:1-12. doi: 10.1159/000539816. Online ahead of print.

Authors

Marcus Hollenbach¹, Jürgen Feisthammel¹, Christiane Prettin², Felix Gundling³, Wolfgang Schepp³, Jürgen Stein⁴, David Petroff², Albrecht Hoffmeister¹

Affiliations

¹ Division of Gastroenterology, Medical Department II, University of Leipzig Medical Center, Leipzig, Germany.
² Clinical Trial Center Leipzig, University of Leipzig, Leipzig, Germany.
³ Clinic for Gastroenterology, Hepatology and Gastrointestinal Oncology, Bogenhausen Clinic, Munich, Germany.
⁴ Clinic for Internal Medicine, Division of Gastroenterology, Sachsenhausen Clinic, Frankfurt, Germany.

PMID: 38885635
DOI: 10.1159/000539816

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.