Endoscopic Sleeve Gastroplasty

Completed

• Conditions: Morbid Obesity
• Interventions: Procedure: Endoscopic sleeve gastroplasty

• Registration Number: NCT02948621
• Lead Sponsor: IHU Strasbourg

Brief Summary

The endoscopic sleeve gastroplasty allows stomach size reduction through an endoluminal suture approach without any incision. It could reduce the complications associated with current surgical techniques while obtaining the target gastric restriction, weight loss, comorbidities and quality of life improvement.

The primary objective of this study is to assess weight loss after endoscopic sleeve gastroplasty in patients with morbid obesity.

Detailed Description

Gastric restriction is one of the fundamental principles of gastric bypass and gastric banding. Nowadays, practitioners have the possibility to reduce stomach size by merging tissues through an endoscopic endoluminal suture approach without any incision. This could reduce the complications associated with current surgical techniques while obtaining the target gastric restriction, weight loss, comorbidities and quality of life improvement.

The primary objective of this study is to assess weight loss after endoscopic sleeve gastroplasty in patients with morbid obesity according to the technique described in the literature: reduction of the gastric pouch into a sleeve structure by modification of the stomach greater curvature thanks to a plication.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-26
• Study First Submitted QC: 2016-10-26
• Study First Posted: 2016-10-28
• Primary Completion: 2018-05
• Study Completion: 2020-05
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-05
• Last Update Posted: 2024-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patient > 18 years old and < 60 years old
• Patient with morbid obesity for at least 2 years
• Patient who failed medical and diet treatment of obesity
• Patient with no contraindication to anesthesia
• Patient able to understand the study and to provide informed consent.

Exclusion Criteria

• Patient with inflammatory, tumoral or bad quality tissues at endoscopy
• Patient with a history of gastro-intestinal inflammatory disease, stenosis or intestinal adhesions, kidney or liver failure, chronic pancreatic disease
• Patient with a history and/or signs and/or symptoms of gastroduodenal ulcerous disease and/or progressive gastroduodenal ulcerous disease
• Patient with an oesophageal pathology as Zenker's diverticulum, peptic oesophagitis stage 3-4, oesophageal stenosis, Barrett syndrome, oesophageal cancer, dysphagia, achalasia
• Patient with previous bariatric, gastric or oesophageal surgery, intestinal obstruction, portal hypertension, gastro-intestinal tumors, oesophageal or gastric varices, gastroparesis
• Patient with a severe coagulopathy (prothrombin time > 3 seconds or thrombocytic count < 50 000/mm3) or treated with heparin, coumadin, warfarin or any other anticoagulants and drugs preventing coagulation or platelet aggregation, except aspirin and nonsteroidal anti-inflammatory drugs
• Pregnancy, breastfeeding or woman without contraception
• Patient with a congestive heart failure, arrhythmia or unstable coronary heart disease
• Patient using or having used diet drugs within the last 30 days or intending to use them during study follow-up
• Patient under drug treatment within the last 3 months known to induce weight gain
• Patient with eating disorders or uncontrolled, poorly controlled or suspected psychiatric disease
• Patient in a poor condition according to investigator
• Patient in exclusion period (determined by a previous study or in progress)
• Patient with significative weight loss between date of enrollment in the study and date of procedure
• Patient with a systemic infection the day of procedure.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endoscopic sleeve gastroplasty	Endoscopic sleeve gastroplasty	Endoscopic sleeve gastroplasty is performed using a CE marked endoscopic suture device (Overstitch, Apollo Endosurgery, Austin, Tx. USA). Continuous stitches are placed to create a sleeve-shaped gastric path of 2 cm diameter to reduce stomach volume from the proximal antrum to the oeso-gastric junction.

Primary Outcome Measures

Name	Time	Method
Weight loss	7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
Body mass index variation	7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
Excess weight loss	7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure

Secondary Outcome Measures

Name	Time	Method
Procedure reproducibility	7 days, 1 - 3 - 6 - 9 and 12 months after procedure	Absence of adverse event within 12 months after procedure.
Comorbidities improvement	7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure	Improvement of hyperlipidemia, arterial hypertension, diabetes, reflux, osteoarticular disorders compared with preoperative data.
Quality of life improvement	3 - 12 - 18 and 24 months after procedure	Improvement of quality of life assessed by Moorehead-Ardelt Quality of life II questionnaire and Gastro-intestinal Quality of Life Index questionnaire.
Modification in the feeling of satiety	1 - 3 - 6 - 12 - 18 and 24 months after procedure	Satiety assessed by Three Factors Eating Questionnaire - R18.

Trial Locations

Locations (1)

Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil de Strasbourg; 🇫🇷 Strasbourg, France