Clinical trial NCT06299644: Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss
Official title: Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss Using the Endomina Plicating Device: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity
Obesity, Morbid
Metabolic Disease
Weight, Body
Keywords: Endoscopic Bariatric and Metabolic Therapies (EBMT)
Endoscopic Bariatric Therapies (EBT)
Gastric emptying
Endoscopic Suturing
endoscopic sleeve gastroplasty (ESG)
Weight Loss
Bariatric Endoscopy
Weight Management
Endoscopic plication
Gastric plication
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Endo Tools Therapeutics S.A.
First posted: 2024-03-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Investigators propose suture plication placement at the distal gastric body drives a significant portion of weight loss in endoscopic sleeve and sutures only need to be placed in the distal gastric body. Therefore, in this pilot study, the investigators aim to compare "belt" with "belt and suspenders" plication pattern using the Endomina system to determine percent total weight loss.

Detailed description: Obesity is a major global health concern. In the US, from 1999 through 2020, the prevalence of obesity has increased from 30.5% to 41.9%. Obesity, defined as the body mass index of more than 30 kg/m2, increases the risk of metabolic diseases and has become the leading cause of death including cardiovascular disease, stroke and cancers.

At present, obesity treatment ranges from lifestyle modification, pharmacotherapy, endoscopic to surgical intervention. Though bariatric surgery has proven to be the most effective treatment in terms of weight loss, it still carries the complication rates of 0.6% - 4.9%.

Endoscopic Bariatric and Metabolic Therapy (EBMT) has emerged as an alternative minimally invasive approach for the patients with morbid obesity with the body mass index (BMI) of 30 - 40 kg/m2. Endoscopic sleeve gastroplasty (ESG) involves placing sutures inside the stomach using an endoluminal full-thickness suturing device. This allows for gastric volume reduction and impaired gastric motility, which results in weight loss. Recent meta-analysis demonstrated ESG, using OverStitch suturing device, percent total weight loss (%TWL) of 16.09 - 16.43% at 12 months after procedure and a serious adverse event rate of 1 - 2.26%. With favorable outcomes and lower complication rates compared to bariatric surgery, ESG has been growing in popularity and increasingly performed worldwide. Other EBT cleared by the U.S. Food and Drug Administration for full thickness tissue approximation include the Incisionless Operating Platform endoscopic plication (USGI Medical, San Clemente, Calif, USA), and Endomina® (Endo Tools Therapeutic, Gosselies, Belgium) which creates gastric plications.

Currently, there is no standardization regarding suturing patterns. One suture pattern for gastric plication that has been used is the "belt and suspenders" pattern whereby plications sutures are placed in the distal gastric body along the width (belt) and mid/proximal gastric body (suspenders). This allows for gastric shortening and reduction in gastric volume. It is suspected this would also alter gastric motility. The distal gastric plications placed near the antrum would result in a disruption of gastric motility; decreased gastric motility would result in decrease gastric emptying and longer satiety.

Eligibility criteria: Inclusion Criteria:

1. Patients with 18-65 years of age
2. BMI ≥ 30 kg/m2
3. Capable of giving informed consent and available to return for follow-up visit

Exclusion Criteria:

1. Untreated H. pylori infection
2. Active gastric or duodenal ulceration
3. Malignant or premalignant gastric diseases (such as intestinal metaplasia, high grade dysplasia, gastric adenocarcinoma, or gastrointestinal stromal tumor (GIST))
4. Severe reflux esophagitis (Los Angeles Classification (LA) Grade C or D)
5. Esophageal or gastric varices and/or portal hypertensive gastropathy
6. Gastroparesis
7. History of gastric surgery/endoscopic procedure
8. Active psychological issues preventing participation in a lifestyle modification program
9. Known history of endocrine disorders affecting weight (uncontrolled hypothyroidism)
10. Severe coagulopathy
11. Active smoking
12. Substance abuse
13. Serious health condition that increased risk of anesthesia and/or endoscopic procedure
14. Pregnancy or lactation
15. Patients who require Non-Steroidal Anti-inflammatory Drugs (NSAID) use

Primary outcomes:
measure: Percent TWL (%TWL)
timeFrame: Baseline, 6 months, 12 months
measure: Adverse Events
timeFrame: 6 months, 12 months
Secondary outcomes:
measure: Gastric Emptying
timeFrame: Baseline, 6 month, 12 months
measure: Number of participants with improvement in fasting glucose
timeFrame: Baseline, 6 months, 12 months
measure: Number of participants with improvement in Hemoglobin A1c (HgA1c %)
timeFrame: Baseline, 6 months, 12 months
measure: Improvement in fasting lipids profile
timeFrame: Baseline, 6 months, 12 months
measure: Number of participants with a change in ghrelin hormone values
timeFrame: Baseline, 6 months, 12 months
measure: Obesity-related comorbidities - hypertension
timeFrame: Baseline, 6 months, 12 months
measure: Obesity-related comorbidities - change in hypertension concomitant medications
timeFrame: Baseline, 6 months, 12 months
measure: Obesity-related comorbidities - change in pre-diabetes/diabetes concomitant medications
timeFrame: Baseline, 6 months, 12 months
measure: Obesity-related comorbidities - pre-diabetes/diabetes
timeFrame: Baseline, 6 months, 12 months
measure: Obesity-related comorbidities - gastroesophageal reflux (GERD)
timeFrame: Baseline, 6 months, 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Christopher C Thompson, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ibrahim AM, Ghaferi AA, Thumma JR, Dimick JB. Variation in Outcomes at Bariatric Surgery Centers of Excellence. JAMA Surg. 2017 Jul 1;152(7):629-636. doi: 10.1001/jamasurg.2017.0542.
citation: Docimo S Jr, Aylward L, Albaugh VL, Afaneh C, El Djouzi S, Ali M, Altieri MS, Carter J; American Society for Metabolic and Bariatric Surgery Clinical Issues Committee. Endoscopic sleeve gastroplasty and its role in the treatment of obesity: a systematic review. Surg Obes Relat Dis. 2023 Nov;19(11):1205-1218. doi: 10.1016/j.soard.2023.08.020. Epub 2023 Sep 16. No abstract available.
citation: Singh S, Hourneaux de Moura DT, Khan A, Bilal M, Ryan MB, Thompson CC. Safety and efficacy of endoscopic sleeve gastroplasty worldwide for treatment of obesity: a systematic review and meta-analysis. Surg Obes Relat Dis. 2020 Feb;16(2):340-351. doi: 10.1016/j.soard.2019.11.012. Epub 2019 Dec 10.
citation: Li P, Ma B, Gong S, Zhang X, Li W. Efficacy and safety of endoscopic sleeve gastroplasty for obesity patients: a meta-analysis. Surg Endosc. 2020 Mar;34(3):1253-1260. doi: 10.1007/s00464-019-06889-6. Epub 2019 Jun 24.
citation: Beran A, Matar R, Jaruvongvanich V, Rapaka BB, Alalwan A, Portela R, Ghanem O, Dayyeh BKA. Comparative Effectiveness and Safety Between Endoscopic Sleeve Gastroplasty and Laparoscopic Sleeve Gastrectomy: a Meta-analysis of 6775 Individuals with Obesity. Obes Surg. 2022 Nov;32(11):3504-3512. doi: 10.1007/s11695-022-06254-y. Epub 2022 Sep 2.
citation: Jalal MA, Cheng Q, Edye MB. Systematic Review and Meta-Analysis of Endoscopic Sleeve Gastroplasty with Comparison to Laparoscopic Sleeve Gastrectomy. Obes Surg. 2020 Jul;30(7):2754-2762. doi: 10.1007/s11695-020-04591-4.