Endoscopic Sleeve Gastroplasty for Non-alcoholic Fatty Liver Disease

Recruiting in Palo Alto (17 mi)

Overseen byPichamol Jirapinyo, MD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Brigham and Women's Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease worldwide. Affecting approximately one-third of the United States (U.S.) population, the prevalence of NAFLD increases to 90% in patients with obesity. In 25% of patients, NAFLD progresses to a more severe form-non-alcoholic steatohepatitis (NASH)-which further increases the risks of cirrhosis and hepatocellular carcinoma. In 2017, the lifetime costs of caring for NASH patients in the U.S. were estimated at $222.6 billion, with the cost of caring for the advanced NASH (fibrosis stage ≥ 3) being $95.4 billion. It is projected that the number of NASH cases will increase by 63% from 2015 to 2030. Given the weight loss efficacy of Endoscopic Bariatric and Metabolic Therapies (EBMTs), it has been suggested that EBMTs may serve as a novel treatment category for NASH. Previously, the PI and Co-Is studied the effect of Intragastric balloons (IGB)-the oldest EBMT device-on NASH. EUS liver biopsy performed at the time of IGB removal revealed resolution of all NASH histologic features including fibrosis. A follow-up study by a different group showed similar findings. Furthermore, studies have showed the benefits of S-ESG and Aspiration Therapy (AT) on non-histologic features of NASH. Given the greater weight loss experienced after P-ESG compared to IGB (20% vs 10% TWL) and the more reproducible technique and shorter learning curve of the current P-ESG compared to S-ESG, we aim to assess the effect of P-ESG on NASH.

Eligibility Criteria

This trial is for adults aged 18-65 with obesity (BMI > 30) and advanced liver fibrosis or cirrhosis, who have biopsy-proven NASH. It's not for those with diabetes, gastric varices, decompensated cirrhosis, current smokers, or anyone on weight loss programs/medications recently.

Inclusion Criteria

You have a body mass index (BMI) of over 30, which means you are classified as obese.

I am between 18 and 65 years old.

My liver has advanced scarring.

+1 more

Exclusion Criteria

I have esophageal varices but am taking a beta-blocker for prevention.

My diabetes is confirmed with an HbA1c level of 6.5% or higher.

Patient is pregnant, breast-feeding, or planning to become pregnant during the course of the study.

+8 more

Participant Groups

The study investigates the impact of Endoscopic Sleeve Gastroplasty (ESG) on patients with Non-alcoholic Steatohepatitis (NASH). It will assess changes in liver function and structure through tests like blood work and imaging before and after ESG treatment.

1Treatment groups

Experimental Treatment

Group I: Patients with Obesity and NASH scheduled/recommended for P-ESG ProcedureExperimental Treatment5 Interventions

We will perform a 12-month prospective, single-center, pilot observational study on patients with obesity and NASH with advanced fibrosis who are undergoing P-ESG. A total of 15 patients will undergo EUS-LB with EUS-PPG measurement in a single session prior to and at 12 months following P-ESG