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Procedure

Endoscopic Sleeve Gastroplasty for Non-alcoholic Fatty Liver Disease

N/A

Waitlist Available

Led By Pichamol Jirapinyo, MD, MPH

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient is 18-65 years old

Advanced fibrosis (defined as bridging fibrosis (F3) or cirrhosis (F4) on LB).

Must not have

diabetes mellitus (defined as HbA1c ≥ 6.5%)

gastric varices

Timeline

Screening 3 weeks

Treatment Varies

Follow Up months 0, month 1, month 3, month 6, month 9, month 12

Awards & highlights

No Placebo-Only Group

Summary

This trial will assess the effect of P-ESG on non-alcoholic fatty liver disease (NAFLD) by measuring changes in liver fat, inflammation, and fibrosis.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, ESG procedures may include risks such as pain at the procedure site, bleeding, infection risk from endoscopy, potential nutritional deficiencies due to altered digestion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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My liver has advanced scarring.

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I have been diagnosed with NASH through a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have enlarged veins in my stomach.

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Endoscopic procedures are not safe for me.

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I am willing and able to follow the study's schedule.

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I am willing and able to sign the informed consent.

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I have severe liver disease with symptoms like bleeding, fluid buildup, confusion, or jaundice.

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I am taking medication to prevent blood clots.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ months 0, month 1, month 3, month 6, month 9, month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~months 0, month 1, month 3, month 6, month 9, month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and months 0, month 1, month 3, month 6, month 9, month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Month 0 liver function at 12 months.

Secondary study objectives

Change in Month 0 Anthropometric factors at months 1,3,6,9,12.

Change in Month 0 Quality of Life at 12 months.

Change in Month 0 insulin resistance at 6 and 12 months.

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Quality of Life Assessment

2009

Completed Phase 2

~570

0 / 10Eligibility criteria met