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

Launched by WEST VIRGINIA UNIVERSITY · Aug 16, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a procedure called Endoscopic Sleeve Gastroplasty (ESG) to see how effective it is for patients with Nonalcoholic Fatty Liver Disease (NAFLD). ESG is a non-surgical method that helps people lose weight, and the researchers want to understand how it can improve the health and quality of life for those who are obese and have NAFLD. The trial will look at safety, changes in weight, and other health indicators to see how ESG can benefit these patients.

To participate in this trial, you must be between 18 and 75 years old, have a body mass index (BMI) greater than 30, and be scheduled for the ESG procedure. You also need to be able to provide informed consent and follow up with the study requirements. However, there are some conditions that would exclude you from participating, such as having certain serious liver diseases, a history of gastric issues, or other specific health concerns. If you join the trial, you can expect regular check-ins to monitor your progress and health changes after the procedure.

Gender

ALL

Eligibility criteria

• 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