ESG with Fundal Mucosal Ablation (ESG-FUMA)

Endoscopic Sleeve Gastroplasty with Fundal Mucosal Ablation - a Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity and Obesity-related Medical Conditions
• Intervention / Treatment: Procedure: Endoscopic sleeve gastroplasty with fundal mucosal ablation

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephen Ng; Phone Number: (852)35052956; Email: stephenng@surgery.cuhk.edu.hk

Study Locations

• Hong Kong
  • Shatin, Hong Kong
    • Recruiting
    • Chinese University of Hong Kong
    • Contact: Stephen Ka Kei Ng, FRCSEd(Gen)
    • Contact: Philip Wai Yan Chiu, FRCSEd(Gen), MD
    • Contact: Stephen Ng; Phone Number: +85235052956; Email: stephenng@surgery.cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Endoscopic sleeve gastroplasty with fundal mucosal ablation; First part of procedure - endoscopic gastric fundus mucosal ablation Second part of procedure - endoscopic sleeve gastroplasty

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 angular incisura and extending proximally while sparing the fundus. Hemostasis is carefully checked and confirmed before the procedure is completed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Weight change compared to baseline	baseline, 1,3,6,12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Stephen Ng, FRCSEd(Gen), Prince of Wales Hospital, The Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 17, 2025
• First Submitted That Met QC Criteria: January 22, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: CRE-2024.501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No