Endoscopic Sleeve Gastroplasty

Morbid Obesity Clinical Trial

— Endosleeve  

Official title:

Endoscopic Sleeve Gastroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02948621
• Other study ID #: 16-001-OBS
• Status: Completed
• Start date: October 2016
• Est. completion date: May 2020

Study information

• Verified date: January 2024
• Source: IHU Strasbourg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2020
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
France	Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
IHU Strasbourg

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss		7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
Primary	Excess weight loss		7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
Primary	Body mass index variation		7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
Secondary	Procedure reproducibility	Absence of adverse event within 12 months after procedure.	7 days, 1 - 3 - 6 - 9 and 12 months after procedure
Secondary	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
Secondary	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
Secondary	Modification in the feeling of satiety	Satiety assessed by Three Factors Eating Questionnaire - R18.	1 - 3 - 6 - 12 - 18 and 24 months after procedure