Clinical trial NCT02948621: Endoscopic Sleeve Gastroplasty
Official title: Endoscopic Sleeve Gastroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morbid Obesity
Keywords: Endoscopic sleeve gastroplasty
Excess weight loss
Quality of life
Lead sponsor: IHU Strasbourg
Sponsor class: OTHER
First posted: 2016-10-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 years old requiring a treatment for morbid obesity.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Weight loss
timeFrame: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
measure: Excess weight loss
timeFrame: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
measure: Body mass index variation
timeFrame: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
Secondary outcomes:
measure: Procedure reproducibility
timeFrame: 7 days, 1 - 3 - 6 - 9 and 12 months after procedure
measure: Comorbidities improvement
timeFrame: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
measure: Quality of life improvement
timeFrame: 3 - 12 - 18 and 24 months after procedure
measure: Modification in the feeling of satiety
timeFrame: 1 - 3 - 6 - 12 - 18 and 24 months after procedure
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil de Strasbourg
Study officials:
affiliation: Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil de Strasbourg
name: Silvana Perretta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil de Strasbourg
name: Michel Vix, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lopez-Nava G, Galvao MP, da Bautista-Castano I, Jimenez A, De Grado T, Fernandez-Corbelle JP. Endoscopic sleeve gastroplasty for the treatment of obesity. Endoscopy. 2015 May;47(5):449-52. doi: 10.1055/s-0034-1390766. Epub 2014 Nov 7.
citation: Lopez-Nava G, Galvao MP, Bautista-Castano I, Jimenez-Banos A, Fernandez-Corbelle JP. Endoscopic Sleeve Gastroplasty: How I Do It? Obes Surg. 2015 Aug;25(8):1534-8. doi: 10.1007/s11695-015-1714-7.
citation: Lopez-Nava G, Galvao M, Bautista-Castano I, Fernandez-Corbelle JP, Trell M. Endoscopic sleeve gastroplasty with 1-year follow-up: factors predictive of success. Endosc Int Open. 2016 Feb;4(2):E222-7. doi: 10.1055/s-0041-110771. Epub 2016 Jan 15.
citation: Sharaiha RZ, Kedia P, Kumta N, DeFilippis EM, Gaidhane M, Shukla A, Aronne LJ, Kahaleh M. Initial experience with endoscopic sleeve gastroplasty: technical success and reproducibility in the bariatric population. Endoscopy. 2015 Feb;47(2):164-6. doi: 10.1055/s-0034-1390773. Epub 2014 Nov 7.
citation: Abu Dayyeh BK, Rajan E, Gostout CJ. Endoscopic sleeve gastroplasty: a potential endoscopic alternative to surgical sleeve gastrectomy for treatment of obesity. Gastrointest Endosc. 2013 Sep;78(3):530-5. doi: 10.1016/j.gie.2013.04.197. Epub 2013 May 24.