A Physiologic Analysis of Endoscopic Sleeve Gastroplasty (ESG)

Summary

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.

Conditions

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

Interventions

DIAGNOSTIC_TEST

Insulin Resistance

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

BEHAVIORAL

Quality of Life Assessment

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

DIAGNOSTIC_TEST

Liver Function Test

EUS-guided liver biopsy and portal pressure gradient measurement

DIAGNOSTIC_TEST

Radiologic features of NASH

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

DIAGNOSTIC_TEST

Serologic features of NASH

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

Sponsors & Collaborators

• American Society for Gastrointestinal Endoscopy

  collaborator OTHER

• Boston Scientific Corporation

  collaborator INDUSTRY

• Brigham and Women's Hospital

  lead OTHER

Principal Investigators

• Pichamol Jirapinyo, MD, MPH · Brigham and Women's Hospital

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-05-06

Primary Completion

2026-12-24

Completion

2027-12-24

FDA Device

Yes

Countries

• United States

Study Locations