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

Effectiveness of Endoscopic Sleeve Gastroplasty in Obese Patients With Nonalcoholic Fatty Liver Disease

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Nonalcoholic Fatty Liver Disease
• Intervention / Treatment: Procedure: Endoscopic Sleeve Gastroplasty

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• United States
  • West Virginia
    • Morgantown, West Virginia, United States, 26508
      • West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

30 obese patients undergoing an endoscopic sleeve gastroplasty (ESG).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Endoscopic Sleeve Gastroplasty; endoscopic suturing of the stomach	Procedure: Endoscopic Sleeve Gastroplasty; endoscopic suturing of the stomach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Controlled Attenuation Parameter of Steatosis	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.	Baseline (Before ESG)
Change in Controlled Attenuation Parameter of Steatosis	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.	6 months post ESG
Change in Controlled Attenuation Parameter of Steatosis	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.	12 months post ESG
Change in Liver Stiffness Measurement of Fibrosis	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.	Baseline (Before ESG)
Change in Liver Stiffness Measurement of Fibrosis	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.	6 months post ESG
Change in Liver Stiffness Measurement of Fibrosis	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.	12 months post ESG

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometric Evaluation	Changes in Anthropometric evaluation from baseline to 6 months post ESG	6 months post ESG
BMI Changes	Compare the change in BMI from baseline to the 6 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).	6 months post ESG
BMI Changes	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).	12 months post ESG
Excess Weight Loss Changes	Percent excess weight loss change from baseline to 6 months	6 months post ESG
Excess Weight Loss Changes	Percentage of excess weight loss change from baseline to 12 months	12 months post ESG
Total Body Weight Loss Changes	Percentage of total body weight loss (TBWL) from baseline to 6 months	6 months post ESG
Total Body Weight Loss Changes	Percentage of total body weight loss (TBWL) from baseline to 12 months	12 months post ESG
Absolute Body Weight Loss Changes	Percentage of Absolute Body Weight Loss from baseline to 6 months	6 months post ESG
Absolute Body Weight Loss Changes	Percentage of Absolute Body Weight Loss from baseline to 12 months	12 months post ESG

Collaborators and Investigators

• Sponsor: West Virginia University
• Investigators: Principal Investigator: Shailendra Singh, MD, West Virginia University

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2022
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: August 16, 2022
• First Submitted That Met QC Criteria: August 16, 2022
• First Posted (Actual): August 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 2202523300

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No