Gastric Recalibration After Endoscopic Sleeve Gastroplasty

Morbid Obesity Clinical Trial

— ESG-IRM  

Official title:

Assessment of the Impact of Endoscopic Gastric Revision by Application of Additional Sutures on Weight Loss After Endoscopic Sleeve Gastroplasty in Obese Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04945473
• Other study ID #: 20-006
• Status: Recruiting
• Phase: N/A
• Start date: July 13, 2021
• Est. completion date: September 2026

Study information

• Verified date: January 2024
• Source: IHU Strasbourg
• Contact: Pierre GOEPFERT
• Phone: 0390413646
• Email: pierre.goepfert[@]ihu-strasbourg.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Obesity is a health dilemma with an increased risk of premature death. Bariatric surgery is considered to be the most effective and durable treatment for morbid obesity as compared to other available options. However, only the most severe cases, namely class III or class II patients with obesity-related comorbidities fit the criteria for bariatric surgical interventions and are offered these options. Endoscopic sleeve gastroplasty (ESG) is a restrictive procedure based on the tubulization and shortening of the stomach, achieved by means of multiple full-thickness sutures applied endoscopically. ESG offers the possibility to obtain results (weight loss, improvement of comorbidities and quality of life) comparable to conventional surgery while reducing the risk of complications. One of the major advantages of this technique is that it does not make irreversible changes to gastric anatomy and function and can be repeated overtime if needed placing additional sutures. ESG appearance might be subject to changes overtime. In fact, depending on the sutures' integrity, the gastroplasty can be regarded as tight, partially open or completely open. Very little data currently exists in the literature on the effectiveness of endoscopic "revision" with the placement of additional sutures on weight loss and its impact on co-morbidities. In order to objectively assess the benefits and costs of a revision during the follow-up endoscopy patients who present a TWL <10% or a BMI greater than 30 at 6 months from the primary ESG, will be randomized into 2 groups: a "Revision" group in which a revision will be performed systematically in the event of suture disruption at the control EGD, and a "Control" group which will only benefit of a control endoscopy regardless of the state of the gastroplasty.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 in exclusion period (determined by a previous or ongoing study)

• 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.

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Procedure:
• Endoscopic placement of additional sutures
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.

Locations

Country	Name	City	State
France	Service de chirurgie digestive et endocrinienne, NHC	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
IHU Strasbourg

Country where clinical trial is conducted

France, 

References & Publications (6)

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Excess weight loss (EWL)	Evaluation of weight loss in terms of excess body weight evolution (EWL) between the two randomized groups ("Control" vs. "Review"). The evolution of the EWL will be assessed at 3, 6, 12 ,18 and 24 months after the ESG.	The data will be collected at the follow-up consultation, specifically at 3, 6, 12, 18 and 24 months after the ESG
Secondary	Body mass index (BMI)	Evaluation of the weight loss in terms of body mass index (BMI) between the two randomized groups. The evolution of the BMI will be assessed at 3, 6, 12 ,18 and 24 months after the ESG.	The data will be collected at the follow-up consultation, specifically at 3, 6, 12, 18 and 24 months after the ESG
Secondary	Self-esteem and activities evaluation	Assessment of the self-esteem and activities before and after the ESG, using the Moorehead-Ardelt quality of life questionnaire II. Score range from -3.0 to 3.0.; Score from -3.0 to -2.1: very poor quality of life; Score from -2.0 to -1.1: poor quality of life; Score from -1.0 to 1.0: fair quality of life; Score from 1.1 to 2.0: good quality of life; Score from 2.1 to 3.0: very good quality of life. The evolution of will be assessed at 3, 6, 12 ,18 and 24 months after the ESG.	The data will be collected at the follow-up consultation, specifically at 3, 6, 12, 18 and 24 months after the ESG
Secondary	Gastrointestinal quality of life evaluation	Assessment of the gastrointestinal quality of life before and after the ESG, using GIQLI (GastroIntestinal Quality of Life Index) questionnaire. There are 36 questions, each ranged from 0 to 4. A global score >125 is considered as normal. The evolution of the gastrointestinal quality of life will be assessed at 3, 6, 12 ,18 and 24 months after the ESG.	The data will be collected at the follow-up consultation, specifically at 3, 6, 12, 18 and 24 months after the ESG
Secondary	Comorbidity evolution	Assessment of comorbidities by comparing the evolution of comorbidities (hypertension, diabetes, sleep apnea syndrome, GERD with the questionnaire "GERD-Health Related Quality of Life Questionnaire GERD-HRQL", knee osteoarthritis) before and after the ESG. GERD-HRQL questionnaire contains 16 questions, ranged from 0 to 5. The higher the score is, the more important the gastroesophageal reflux is. The evolution of comorbidities will be assessed at 3, 6, 12 ,18 and 24 months after the ESG.	The data will be collected at the follow-up consultation, specifically at 3, 6, 12, 18 and 24 months after the ESG
Secondary	Gastric Emptying evaluation	Evaluation of gastric volume and emptying changes before and after ESG. The evaluation will be carried out performing a dynamic MRI before and 7 months after ESG. Dynamic MRI changes will be put in correlation with weight modifications (TWL, EWL and BMI).	The data will be collected before and 7 months after the ESG
Secondary	Gastric Emptying evaluation	Evaluation of gastric volume and emptying changes before and after ESG. The evaluation will be carried out performing a dynamic MRI before and 7 months after ESG. Dynamic MRI changes will be put in correlation with changes in secretion of intestinal hormones and glycemic profile (blood sugar, HbA1c, insulin, ghrelin, C-peptide, GLP-1 and Glucagon).	The data will be collected before and 7 months after the ESG
Secondary	Gastric Emptying evaluation	Evaluation of changes in gastric volume and gastric emptying comparing the results obtained by dynamic MRI between the two randomized groups ("Control" vs. "Revision"), with an additional correlation study of these results with weight loss: total weight lost (TWL%), excess weight loss (EWL%) and change in BMI. The data will be collected before ESG, and at 3, 6, 12, 18 and 24 months after ESG	The data will be collected before and 7 months after the ESG
Secondary	Gastric Emptying evaluation	Evaluation of changes in gastric volume and gastric emptying comparing the results obtained by dynamic MRI between the two randomized groups ("Control" vs. "Revision"), with an additional correlation study of these results with changes in secretion of intestinal hormones and glycemic profile (blood sugar, HbA1c, insulin, ghrelin, C-peptide, GLP-1 and Glucagon). The data will be collected before and 7 months after the ESG.	The data will be collected before and 7 months after the ESG