Z Gastroenterol 2017; 55(08): e57-e299
DOI: 10.1055/s-0037-1605214
Kurzvorträge
Endoskopie/Minimal invasive Chirurgie
Interventionelle Techniken in der Endoskopie – innovativ und nachhaltig?: Donnerstag, 14 September 2017, 16:00 – 17:46, Rotterdam/Forschungsforum 2
Georg Thieme Verlag KG Stuttgart · New York

Pre-Study protocol 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

M Hollenbach
1   University of Leipzig, Department of Medicine, Neurology and Dermatology; Division of Gastroenterology and Rheumatology, Leipzig, Deutschland
,
W Schepp
2   Bogenhausen Clinic, Clinic for Gastroenterology, Hepatology and Gastrointestinal Oncology, Munich, Deutschland
,
F Grundling
2   Bogenhausen Clinic, Clinic for Gastroenterology, Hepatology and Gastrointestinal Oncology, Munich, Deutschland
,
J Seufert
3   University of Freiburg, Clinic for Internal Medicine II; Division of Endocrinology and Diabetology, Freiburg, Deutschland
,
J Stein
4   Sachsenhausen Clinic, Clinic for Internal Medicine; Division of Gastroenterology, Frankfurt, Deutschland
,
T Rösch
5   University of Hamburg-Eppendorf, Clinic for Interdisciplinary Endoscopy; Center for Radiology and Endoscopy, Hamburg, Deutschland
,
J Aberle
6   University of Hamburg-Eppendorf, Clinic for Endocrinology, Diabetology, Adiopsity and Lipids, Hamburg, Deutschland
,
J Feisthammel
1   University of Leipzig, Department of Medicine, Neurology and Dermatology; Division of Gastroenterology and Rheumatology, Leipzig, Deutschland
,
J Mössner
1   University of Leipzig, Department of Medicine, Neurology and Dermatology; Division of Gastroenterology and Rheumatology, Leipzig, Deutschland
,
C Prettin
7   University of Leipzig, Clinical Trial Center Leipzig, Leipzig, Deutschland
,
D Petroff
7   University of Leipzig, Clinical Trial Center Leipzig, Leipzig, Deutschland
,
A Hoffmeister
1   University of Leipzig, Department of Medicine, Neurology and Dermatology; Division of Gastroenterology and Rheumatology, Leipzig, Deutschland
› Author Affiliations
Further Information

Publication History

Publication Date:
02 August 2017 (online)

Also available at
 

Background:

Obesity is an emerging global problem leading to reduced life expectancy, cardiovascular diseases, diabetes and many types of cancer. Even people willing to accept treatment only achieve a mean weight loss of about 5 kg per year using commercial weight loss programs. Surgical interventions, e.g. sleeve gastrectomy or gastric bypass, are effective but accompanied by serious complications and side effects. Less invasive endoscopic procedures mainly comprise the intragastric balloon (IB) and the duodenal-jejunal bypass liver (DJBL). To date, a randomized comparison between these devices has not been undertaken or shown conclusively to be superior to sham procedure.

Methods:

We designed a multicenter, randomized, double-blinded, controlled trial comparing weight loss in endoscopically implanted IB vs. DJBL vs. a sham procedure. A total of 150 patients with a BMI > 35 kg/m2 or > 30 kg/m2 with obesity-related comorbidities and medical indication for proton pump inhibitors are randomized to receive either IB or DJBL or sham gastroscopy (2:2:1). All participants underwent regular dietary consultation. The IB will be removed after 6 months, DJBL after 12 months. All patients receive 3 gastroscopies or sedation without gastroscopy to maintain blinding. Main exclusion criteria are malignant diseases, peptic ulcer or previous bariatric intervention. Weight loss 12 months after explantation of the devices, changes in co-morbidities, quality of life, complication rates and safety will be evaluated.

Conclusions:

This trial could help identify the most effective and safest endoscopic device, thus determining the new standard procedure for endoscopic bariatric treatment.

Trial registration:

DRKS00011036. Funded by Deutsche Forschungsgesellschaft (DFG)