Endoscopy 2022; 54(S 01): S54-S55
DOI: 10.1055/s-0042-1744676
Abstracts | ESGE Days 2022
ESGE Days 2022 Oral presentations
10:00–11:00 Friday, 29 April 2022 Club A. Bariatric endoscopy: efficacy and outcomes

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

A. Hoffmeister
1   University of Leipzig Medical Center, Division of Gastroenterology, Medical Department II, Leipzig, Germany
,
M. Hollenbach
1   University of Leipzig Medical Center, Division of Gastroenterology, Medical Department II, Leipzig, Germany
,
C. Prettin
2   University of Leipzig, Clinical Trial Center Leipzig, Leipzig, Germany
,
F. Gundling
3   Bogenhausen Clinic, Clinic for Gastroenterology, Hepatology and Gastrointestinal Oncology, Munich, Germany
,
W. Schepp
3   Bogenhausen Clinic, Clinic for Gastroenterology, Hepatology and Gastrointestinal Oncology, Munich, Germany
,
J. Seufert
4   University of Freiburg, Clinic for Internal Medicine II; 5 Division of Endocrinology and Diabetology, Freiburg, Germany
,
J. Stein
5   Sachsenhausen Clinic, Clinic for Internal Medicine; 7 Division of Gastroenterology; 8 Frankfurt, Germany
,
J. Aberle
6   University of Hamburg-Eppendorf, Clinic for Endocrinology, Diabetology, Adiopsity and Lipids, Hamburg, Germany
,
J. Feisthammel
1   University of Leipzig Medical Center, Division of Gastroenterology, Medical Department II, Leipzig, Germany
,
D. Petroff
2   University of Leipzig, Clinical Trial Center Leipzig, Leipzig, Germany
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    Aims Obesity is a global problem leading to reduced life expectancy and obesity-related co-morbidities. Surgical interventions are effective but accompanied by risk of serious complications. Endoscopic procedures comprise the intragastric-balloon (IB) and the duodenal-jejunal-bypass-liner (DJBL). A randomized comparison was not undertaken so far.

    Methods We performed a prospective, patient-and-assessor-blinded, controlled trial at comparing weight loss in IB vs. DJBL vs. 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. Secondary outcomes were changes in co-morbidities, quality of life and complications.

    Results 33 patients were randomized. Recruitment has to be stopped suddenly in November 2017 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±28.3 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 at 12 months) but patients regained weight almost to baseline level 12 months after explantation. Only one patient in IB group reached the primary endpoint. Gastrointestinal disorders were most common adverse events in all groups.

    Conclusions Endoscopic bariatric procedures failed to achieve effective weight loss 12 month after explantation of the devices. Results of this trial need to be interpreted with caution due to its preliminary termination.


     

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    Artikel online veröffentlicht:
    14. April 2022

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