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.

Research Team

Pichamol Jirapinyo, MD, MPH

Principal Investigator

Brigham and Women's Hospital

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.

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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.

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Treatment Details

Interventions

P-ESG (Procedure)

Trial OverviewThe 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.

Participant Groups

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