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

West Virginia University

Status

Enrolling

Conditions

Nonalcoholic Fatty Liver Disease

Treatments

Procedure: Endoscopic Sleeve Gastroplasty

Study type

Observational

Funder types

Other

Identifiers

NCT05507151

2202523300

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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