Gastric Recalibration After Endoscopic Sleeve Gastroplasty

NCT04945473 | Recruiting

• 1 other identifier: 20-006
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Endoscopic sleeve gastroplasty (ESG) is a technique used for bariatric surgery, with results comparable to conventional surgery, in order to treat morbid obesity. It has also less risks of complications, and it is not an irreversible technique. It can be repeated overtime, regarding the evolution of the gastroplasty. There is little data in the literature on the effectiveness of endoscopic "revision". This study will assess the benefits and costs of a revision during the follow-up endoscopy.

Conditions

Morbid Obesity

Keywords

obesity; Endoscopy; ESG; Gastric emptying; Revision procedure

Outcome Measures

Primary Outcomes (1)

• Total weight loss (TWL)

  The primary endpoint is the assessment of weight evolution in terms of total weight loss (TWL) between the two randomized groups ("Control" vs. "Review"). The evolution of the TWL will be assessed at 3, 6, 12 ,18 and 24 months after the ESG.

  3, 6, 12, 18 and 24 months after the ESG

Secondary Outcomes (9)

• Excess weight loss (EWL)

  The data will be collected at the follow-up consultation, specifically at 3, 6, 12, 18 and 24 months after the ESG

• Body mass index (BMI)

  The data will be collected at the follow-up consultation, specifically at 3, 6, 12, 18 and 24 months after the ESG

• Self-esteem and activities evaluation

  The data will be collected at the follow-up consultation, specifically at 3, 6, 12, 18 and 24 months after the ESG

• Gastrointestinal quality of life evaluation

  The data will be collected at the follow-up consultation, specifically at 3, 6, 12, 18 and 24 months after the ESG

• Comorbidity evolution

  The data will be collected at the follow-up consultation, specifically at 3, 6, 12, 18 and 24 months after the ESG

Study Arms (2)

Revision

EXPERIMENTAL

BMI≥30 or total weight loss (TBWL) \< 10% and relaxation of gastric tubulisation at 6 months after ESG. Additional stitches will be placed during the follow-up gastroscopy at 6 months.

Procedure: Endoscopic placement of additional sutures

Without revision

NO INTERVENTION

The control gastroscopy will be performed without any additional procedure (no additional stitches).

Interventions

Endoscopic placement of additional sutures PROCEDURE

A new endoscopic suture will be performed in case of a BMI≥30 or total weight loss (TBWL) less than 10%, and relaxation of gastric tubulization during the regular endoscopic follow-up after 6 months from the ESG. The same endoscopic suture technique of the primary ESG will be applied.

Revision

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 to 75
• Patients with morbid obesity (BMI≥ 30 with comorbidities or\> 40)
• Patients with obesity for more than 2 years
• Failure of medical treatment of obesity
• Patients who may benefit from general anaesthesia
• Patient able to participate in all aspects of the study and that agree to comply with all study requirements, for the duration of the study. This includes the availability of reliable transportation and sufficient time to attend all follow-up visits.
• Patient able to fully understand the study and ready to give consent to participate to the study.
• Patient affiliated to the French social security system

You may not qualify if:

• Patient with a contraindication to perform an ESG
• Patient with a history of previous bariatric, gastric or esophageal surgery.
• Patient who initiated medical therapy within the last 3 months, with evidence of weight gain.
• Patient with an uncontrolled, poorly controlled, or suspected history of eating disorders or psychiatric illness.
• Patient with unstable and precarious state of health, as determined and assessed by the investigator.
• Patient who is pregnant, breastfeeding or of childbearing age and without effective contraception.
• Patient under legal protection
• Patient under guardianship or curatorship
• Patients with a BMI less than 30 at 6 months after ESG. These patients will not be candidate for revision regardless of the randomization group.
• Patients with a contraindication to MRI may be included in the study and will follow the "No Imaging" study design.

Sponsors & Collaborators

• IHU Strasbourg: lead

Study Sites (1)

Service de chirurgie digestive et endocrinienne, NHC

Strasbourg, 67000, France

RECRUITING

Related Publications (6)

• Willett WC, Dietz WH, Colditz GA. Guidelines for healthy weight. N Engl J Med. 1999 Aug 5;341(6):427-34. doi: 10.1056/NEJM199908053410607. No abstract available.

  PMID: 10432328 BACKGROUND

• 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.

  PMID: 25380510 BACKGROUND

• 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.

  PMID: 26878054 BACKGROUND

• 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.

  PMID: 26003549 BACKGROUND

• 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.

  PMID: 25380508 BACKGROUND

• 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.

  PMID: 23711556 BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Silvana PERRETTA, MD, PHD

  Service de chirurgie digestive et endocrinienne, NHC, Strasbourg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre GOEPFERT

CONTACT

0390413646; pierre.goepfert@ihu-strasbourg.eu

Armelle TAKEDA

CONTACT

0390413608; armelle.takeda@ihu-strasbourg.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 30, 2021
• Study Start: July 13, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)