Effectiveness of Endoscopic Sleeve Gastroplasty in Nonalcoholic Fatty Liver Disease/Nonalcoholic Steatohepatitis

Recruiting

• Conditions: Nonalcoholic Fatty Liver Disease
• Interventions: Procedure: Endoscopic Sleeve Gastroplasty

• Registration Number: NCT05507151
• Lead Sponsor: West Virginia University

Brief Summary

Endoscopic weight loss procedures, also termed endoscopic sleeve gastroplasty (ESG), has been proposed as a non-surgical procedure for managing obesity and offers a standard weight loss approach. Realizing there is a knowledge gap in applying ESG to morbidly obese patients with NAFLD, the investigators propose studying the efficacy of weight control and functional outcomes of ESG. This prospective pilot study is aimed to study the safety profiles, quality of life, and changes and improvements in the anthropometric, metabolic, and biochemical changes in these patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-16
• Study First Submitted QC: 2022-08-16
• Study First Posted: 2022-08-18
• Study Start: 2022-08-24
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-13
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Body mass index (BMI) greater than 30 kg/m2, who are eligible for ESG
• Patients scheduled to undergo an endoscopic bariatric weight loss procedure (ESG)
• Patients older than 18 years and younger than 75 years of age at the time of consent
• Patients able to provide written informed consent on the Institutional review board (IRB) approved informed consent form
• Patients willing and able to comply with study requirements for follow-up

Exclusion criteria:

• Patients who are treated with intragastric balloons
• Family history of esophageal, gastric, or duodenal malignancy and active gastric ulceration,
• Pre-existing esophageal stenosis/stricture preventing the advancement of an endoscope during screening/baseline Esophagogastroduodenoscopy (EGD)
• Presence of any gastric condition which required endoscopic surveillance (e.g., known gastric intestinal metaplasia),
• Known vascular abnormalities, obligate therapeutic anticoagulation, and pregnancy/lactation
• Evidence of end-stage liver disease, including portal hypertension, ascites, and coagulopathy
• Positivity for hepatitis B virus or hepatitis C virus, current alcohol consumption of more than 20 g/day in females and more than 30 g/day in males on average, use of medications with reported hepato-steatogenic effect (amiodarone, tamoxifen, estrogens), and drug-induced liver disease
• Type 1 diabetes, Prior bariatric surgery, Autoimmune liver disease (antinuclear antibody titer >1/160), Wilson's disease, hemochromatosis, alpha1-antitrypsin deficiency,
• Known positivity for human immunodeficiency virus, a concomitant disease with reduced life expectancy, severe psychiatric condition, drug dependence, or inability to provide informed consent.
• The patient refuses or is unable to provide written informed consent
• Prior bariatric treatment procedure

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endoscopic Sleeve Gastroplasty	Endoscopic Sleeve Gastroplasty	endoscopic suturing of the stomach

Primary Outcome Measures

Name	Time	Method
Change in Controlled Attenuation Parameter of Steatosis	12 months post ESG	The CAP measures ultrasonic attenuation in the liver at 3.5 MHz using signals acquired by the FibroScan® M probe based on vibration-controlled transient elastography. The final CAP value, which ranges from 100 to 400 decibels per metre (dB/m), is the median of individual measurements. Higher measure indicates higher portion of liver affected by fatty change.
Change in Liver Stiffness Measurement of Fibrosis	12 months post ESG	Liver stiffness result is measured in kilopascals (kPa) Range is 0-75kPa. Normal results are usually between 2 and 7 kPa. The highest possible result is 75 kPa. Higher results indicate liver disease.

Secondary Outcome Measures

Name	Time	Method
Anthropometric Evaluation	6 months post ESG	Changes in Anthropometric evaluation from baseline to 6 months post ESG
Excess Weight Loss Changes	12 months post ESG	Percentage of excess weight loss change from baseline to 12 months
BMI Changes	12 months post ESG	Compare the change in BMI from baseline to the 12 months post ESG. Body Mass Index (BMI) is a person's weight in kilograms (or pounds) divided by the square of height in meters (or feet).
Absolute Body Weight Loss Changes	12 months post ESG	Percentage of Absolute Body Weight Loss from baseline to 12 months
Total Body Weight Loss Changes	12 months post ESG	Percentage of total body weight loss (TBWL) from baseline to 12 months

Trial Locations

Locations (1)

West Virginia University; 🇺🇸 Morgantown, West Virginia, United States