ESG with Fundal Mucosal Ablation

Not Applicable

Recruiting

• Conditions: Obesity and Obesity-related Medical Conditions

• Registration Number: NCT06790329
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-01
• Study First Submitted: 2025-01-17
• Study First Submitted QC: 2025-01-22
• Last Update Submitted: 2025-01-22
• Study First Posted: 2025-01-24
• Last Update Posted: 2025-01-24
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Body weight	baseline, 1,3,6,12 months	Weight change compared to baseline

Secondary Outcome Measures

Name	Time	Method
Adverse events	within 30 days of procedure	Adverse events relating to endoscopic intervention, graded according to the Common Terminology Criteria for Adverse Events (CTCAE)
Technical success rate	1 day	successful completion of endoscopic procedures
Serum ghrelin levels	baseline, 3,6,12 months	Serum ghrelin levels compared to baseline
Blood pressure	baseline, 1,3,6,12 months	Blood pressure and anti-hypertensive medication use compared to baseline
Lipid profile	baseline, 3,6,12 months	Lipid profile compared to baseline
Pain scale after procedure	3 days	measured by visual analogue scale (0:no pain - 10:worst pain)
Change in Quality of Life	baseline, 3,6,12 months	measured by 36-Item Short Form Survey (SF-36) questionnaire - (score 0:worst - 100:best)
Gastric emptying symptoms	baseline, 3,6,12 months	measured by gastroparesis cardinal symptom index (GCSI) - (0:best - 45:worst)
Eating behaviors	baseline, 3,6,12 months	measured by Three-Factor Eating Questionnaire (TFEQ-R21) - (21:worst - 84:best)
Fasting glucose level	baseline, 3,6,12 months	levels compared to baseline
Insulin level	baseline, 3,6,12 months	levels compared to baseline
HbA1c level	baseline, 3,6,12 months	levels compared to baseline
hepatic steatosis index	baseline, 3,6,12 months	level compared to baseline
NAFLD fibrosis	baseline, 3,6,12 months	NAFLD fibrosis scores compared to baseline (F0: no liver fibrosis - F4: significant liver fibrosis)

Trial Locations

Locations (1)

Chinese University of Hong Kong; 🇭🇰 Shatin, Hong Kong