Endoscopic Sleeve Gastroplasty

Study Overview
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Brief Summary
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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
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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.

Official Title
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Endoscopic Sleeve Gastroplasty

Conditions
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Morbid Obesity

Intervention / Treatment
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* Procedure: Endoscopic sleeve gastroplasty


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endoscopic sleeve gastroplasty<br>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. | Procedure: Endoscopic sleeve gastroplasty<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss |  | 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 | 
| Body mass index variation |  | 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic sleeve gastroplasty, Excess weight loss, Quality of life