ESG With Fundal Mucosal Ablation

Official title

Endoscopic Sleeve Gastroplasty With Fundal Mucosal Ablation - a Pilot Study

Overview

Endoscopic sleeve gastroplasty (ESG) have emerged as an effective primary endoscopic therapy for weight loss. While ESG recapitulates the configuration of a gastric sleeve, it has not yet been shown to achieve as robust weight loss outcomes compared to the laparoscopic sleeve gastrectomy (LSG). A major difference between ESG and LSG is that the former does not involve the gastric fundus and therefore does not lead to decrease in fasting plasma ghrelin after procedure. Recently, a new endoscopic technique involving the ablation of the gastric fundus has been developed, showing promising results with a reduction in fasting plasma ghrelin levels and a mean total body weight loss of 7.7%. Combining endoscopic gastric fundus mucosal ablation with ESG could potentially enhance the weight loss effects of ESG while maintaining an acceptable safety profile. This pilot study aims to evaluate the efficacy, safety, and physiological effects of combining endoscopic sleeve gastroplasty with fundal mucosal ablation (ESG-FUMA) in obese patients eligible for endoscopic bariatric therapies.

Interventions

• Procedure Endoscopic sleeve gastroplasty with fundal mucosal ablation
  Mucosal ablation around the gastric fundus is initially performed using a hybrid argon plasma coagulation (H-APC) probe, following a submucosal saline injection, until ablation coagulum is visible. Subsequently, endoscopic sleeve gastroplasty (ESG) is performed using a full-thickness endoscopic suturing device (Overstitch, Apollo). This is done in a standard manner, employing 6-8 permanent full-thickness sutures along the greater curvature of the stomach in a running plication, starting from the

Primary outcome measures

• Body weight [Time frame: baseline, 1,3,6,12 months]

Secondary outcome measures (12)

• Adverse events [Time frame: within 30 days of procedure]
• Technical success rate [Time frame: 1 day]
• Serum ghrelin levels [Time frame: baseline, 3,6,12 months]
• Blood pressure [Time frame: baseline, 1,3,6,12 months]
• Lipid profile [Time frame: baseline, 3,6,12 months]
• Pain scale after procedure [Time frame: 3 days]
• Change in Quality of Life [Time frame: baseline, 3,6,12 months]
• Gastric emptying symptoms [Time frame: baseline, 3,6,12 months]
• Eating behaviors [Time frame: baseline, 3,6,12 months]
• Fasting glucose level [Time frame: baseline, 3,6,12 months]
• Insulin level [Time frame: baseline, 3,6,12 months]
• HbA1c level [Time frame: baseline, 3,6,12 months]

Eligibility criteria

Inclusion criteria

• BMI equal or more than 30kg/m2 (27.5kg/m2 for Chinese or South Asian) to 40kg/m2, or BMI equal or more than 40kg/m2 and patient is either high risk for surgery or unwilling to undergo surgery, AND
• failed standard obesity therapy of diet, exercise, behavior modification, and pharmacologic agents either alone or in combination

Exclusion criteria

• Previous upper GI surgery (e.g. bariatric surgery, anti-reflux surgery; gastrectomy; esophageal surgery)
• Previous ESG
• Gastroparesis
• Active smoking
• An ongoing or a history of treatment with opioids in the last 12 months prior to enrollment
• Previous pyloromyotomy or pyloroplasty
• Gastrointestinal obstruction
• Use of any medication that may interfere with weight loss or gastric emptying
• Severe coagulopathy
• Esophageal or gastric varices and/or portal hypertensive gastropathy
• Underlying uncontrolled endocrine problem that leads to obesity. (e.g. Hypothyroidism, Cushing syndrome, eating disorder etc.)
• Any inflammatory disease of the gastrointestinal tract (including but not limited to severe (LA Grade C or D) esophagitis, active gastric ulceration, active duodenal ulceration, or specific inflammation such as Crohn's disease)
• Malignancy
• Pregnant or breast feeding
• Patients not fit for general anesthesia
• ASA grade IV or V
• Mental or psychiatric disorder; Drug or alcohol addiction
• Other cases deemed by the examining physician as unsuitable for safe treatment
• Refusal to participate

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

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Hong Kong · 1 center

• Chinese University of Hong Kong — Shatin

Identifiers

NCT: NCT06790329 · CRE-2024.501

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗