Clinical trial NCT06790329: ESG With Fundal Mucosal Ablation
Official title: Endoscopic Sleeve Gastroplasty With Fundal Mucosal Ablation - a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity and Obesity-related Medical Conditions
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Body weight
timeFrame: baseline, 1,3,6,12 months
Secondary outcomes:
measure: Adverse events
timeFrame: within 30 days of procedure
measure: Technical success rate
timeFrame: 1 day
measure: Serum ghrelin levels
timeFrame: baseline, 3,6,12 months
measure: Blood pressure
timeFrame: baseline, 1,3,6,12 months
measure: Lipid profile
timeFrame: baseline, 3,6,12 months
measure: Pain scale after procedure
timeFrame: 3 days
measure: Change in Quality of Life
timeFrame: baseline, 3,6,12 months
measure: Gastric emptying symptoms
timeFrame: baseline, 3,6,12 months
measure: Eating behaviors
timeFrame: baseline, 3,6,12 months
measure: Fasting glucose level
timeFrame: baseline, 3,6,12 months
measure: Insulin level
timeFrame: baseline, 3,6,12 months
measure: HbA1c level
timeFrame: baseline, 3,6,12 months
measure: hepatic steatosis index
timeFrame: baseline, 3,6,12 months
measure: NAFLD fibrosis
timeFrame: baseline, 3,6,12 months
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Chinese University of Hong Kong
Study officials:
affiliation: Prince of Wales Hospital, the Chinese University of Hong Kong
name: Stephen Ng, FRCSEd(Gen)
role: PRINCIPAL_INVESTIGATOR
References: