ESG With Fundal Mucosal Ablation

Chinese University of Hong Kong10 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obesity and Obesity-related Medical Conditions

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Body weight

Weight change compared to baseline

Time frame: baseline, 1,3,6,12 months

Secondary Outcomes

Adverse events

Adverse events relating to endoscopic intervention, graded according to the Common Terminology Criteria for Adverse Events (CTCAE)

Time frame: within 30 days of procedure

Technical success rate

successful completion of endoscopic procedures

Time frame: 1 day

Serum ghrelin levels

Serum ghrelin levels compared to baseline