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Weight-loss Endoscopy Trial

WET: EndoBarrier vs Orbera Intragastric Balloon

The multi-centre, randomised, controlled trial will recruit a total of 150 patients with a BMI>35 or BMI>30 with obesity-related comorbidities and indication for proton pump inhibitors

Researchers from Germany have established the Weight-loss Endoscopy Trial that will compare weight loss following an endoscopically implanted duodenal-jejunal bypass liner (DJBL, EndoBarrier system GI Dynamics), the Orbera Intragastric Balloon (IB, Apollo Endosurgery) and a sham procedure. According to the WET investigators from the University of Leipzig, Leipzig, the Bogenhausen Clinic, Munich, the University of Freiburg, Freiburg and the University of Hamburg-Eppendorf, Hamburg, Germany, this will be the first randomised comparison between these devices. The paper outlining the study, ‘Design of the 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’, was published in BMC Gastroenterology.

The multi-centre, randomised, controlled trial will recruit a total of 150 patients with a BMI>35 or BMI>30 with obesity-related comorbidities and indication for proton pump inhibitors, and patients will be randomised to receive either IB, DJBL or a sham gastroscopy (2:2:1 ratio). The IB will be removed after six months and the DJBL will be explanted after 12 months. All patients will receive gastroscopies at implantation and explantation of the devices or sedation without gastroscopy to maintain blinding. In addition to weight loss, the influence of DJBL and IB on obesity-related co-morbidities (diabetes and associated diseases, hypertension, dyslipidaemia, renal failure, coronary artery disease, heart failure, endocrinologic and psychiatric disorders, fatty liver and pulmonary diseases) and quality of life will also be analysed.

All patients are requested to attend study visits one, three, six, 12 and 24 months after implantation of the devices or initial sham endoscopy (see Figure 1 for detailed trial flow chart).

Figure 1: Treatment scheme

“The novelty of our study design is that the WET study compares two endoscopic devices with different modes of action and different implantation periods related to the sham group. To ensure blinding of the study, all patients will undergo three endoscopies or sedation without gastroscopy, respectively,” the authors conclude. “Although these requirements lead to a complex study protocol, the WET study will hopefully clarify important questions in endoscopic and conservative management of obesity. Assuming they are superior to a sham procedure, the more effective and safer device between DJBL and IB could become a more standard intervention for the therapy of obesity and its complications.”

The trial is sponsored by the German Research Foundation, which is not involved in the database management and has no access to randomisation codes.

To access this paper, please click here

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