Clinical trial

A Physiologic Analysis of Endoscopic Sleeve Gastroplasty (ESG)

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT04820036

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionNon-alcoholic Steatohepatitis (NASH), Endoscopic Sleeve Gastroplasty, Non-alcoholic Fatty Liver Disease (NAFLD), Endoscopic Ultrasound, Liver Function, Obesity, Liver Fibroses

Full registry criteria

Inclusion Criteria: * Patient is 18-65 years old * Obesity (defined as BMI \> 30 kg/m2) * Biopsy-proven NASH (defined as the presence of steatosis and hepatic injury in the form of ballooning or lobular inflammation)19 * Advanced fibrosis (defined as bridging fibrosis (F3) or cirrhosis (F4) on LB). Exclusion Criteria: * Decompensated cirrhosis (defined as bleeding varices, ascites, encephalopathy and jaundice) * gastric varices * diabetes mellitus (defined as HbA1c ≥ 6.5%) * active smoking * being on an anticoagulant or anti-platelet medication * active participation in any weight loss program, the use of a weight loss medication over the past 6 months and history of bariatric surgery or EBMT. * Patients with esophageal varices are not excluded as long as they are on a non-selective beta-blocker for primary prophylaxis. * Patient is pregnant, breast-feeding, or planning to become pregnant during the course of the study. * Patient is unwilling or unable to sign and date the informed consent. * Patient is unwilling or unable to comply with the follow-up study schedule. * Patient for whom endoscopic procedures are contraindicated.

Treatments and study arms

Insulin Resistance

Diagnostic Test

Insulin resistance: Fasting glucose and insulin will also be measured to calculate Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), as a surrogate of IR

Quality of Life Assessment

Behavioral

Quality of life will be assessed using the Chronic Liver Disease Questionnaire.

Liver Function Test

Diagnostic Test

EUS-guided liver biopsy and portal pressure gradient measurement

Radiologic features of NASH

Diagnostic Test

Controlled attenuation parameter (CAP) and liver stiffness scores assessed by transient elastography (TE)

Serologic features of NASH

Diagnostic Test

Laboratory value assessment of alanine aminotransferase (ALT), liver chemistries, platelet counts, albumin and calculated NAFLD Fibrosis Score (NFS).

Primary outcomes

Change in Month 0 liver function at 12 months.Month 0, Month 12

EUS-guided liver biopsy with portal pressure gradient measurement

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Brigham and Women's Hospital🇺🇸 Boston, Massachusetts, United States

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