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

Overview

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.

Interventions

• Device Endoscopic Sleeve Gastroplasty - Belt and Suspenders
  Endoscopic sleeve gastroplasty using belt and suspender plications.
• Device Endoscopic Sleeve Gastroplasty - Belt
  Endoscopic sleeve gastroplasty using belt only plications.

Primary outcome measures

• Percent TWL (%TWL) [Time frame: Baseline, 6 months, 12 months]
• Adverse Events [Time frame: 6 months, 12 months]

Secondary outcome measures (10)

• Gastric Emptying [Time frame: Baseline, 6 month, 12 months]
• Number of participants with improvement in fasting glucose [Time frame: Baseline, 6 months, 12 months]
• Number of participants with improvement in Hemoglobin A1c (HgA1c %) [Time frame: Baseline, 6 months, 12 months]
• Improvement in fasting lipids profile [Time frame: Baseline, 6 months, 12 months]
• Number of participants with a change in ghrelin hormone values [Time frame: Baseline, 6 months, 12 months]
• Obesity-related comorbidities - hypertension [Time frame: Baseline, 6 months, 12 months]
• Obesity-related comorbidities - change in hypertension concomitant medications [Time frame: Baseline, 6 months, 12 months]
• Obesity-related comorbidities - change in pre-diabetes/diabetes concomitant medications [Time frame: Baseline, 6 months, 12 months]
• Obesity-related comorbidities - pre-diabetes/diabetes [Time frame: Baseline, 6 months, 12 months]
• Obesity-related comorbidities - gastroesophageal reflux (GERD) [Time frame: Baseline, 6 months, 12 months]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Brigham and Women's Hospital — Boston

Publications

• 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. PMID 28445566
• 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. PMID 37813705
• 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. PMID 31932205
• 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. PMID 31236722
• 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. PMID 36053446
• 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. PMID 32304011

Identifiers

NCT: NCT06299644 · 2023P003282

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗