Effectiveness of Endoscopic Sleeve Gastroplasty in Nonalcoholic Fatty Liver Disease/Nonalcoholic Steatohepatitis
Purpose
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.
Condition
- Nonalcoholic Fatty Liver Disease
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Endoscopic Sleeve Gastroplasty | endoscopic suturing of the stomach |
|
Recruiting Locations
West Virginia University
Morgantown, West Virginia 26508
Morgantown, West Virginia 26508
More Details
- NCT ID
- NCT05507151
- Status
- Recruiting
- Sponsor
- West Virginia University