A Physiologic Analysis of Endoscopic Sleeve Gastroplasty (ESG)

NCT04820036 | Active Not Recruiting FDA Device

• 1 other identifier: 2020P003540
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Month 0 liver function at 12 months.

  EUS-guided liver biopsy with portal pressure gradient measurement

  Month 0, Month 12

Secondary Outcomes (5)

• Change in Month 0 radiologic features of NASH at 6 and 12 months.

  Month 0, Month 6, Month 12

• Change in Month 0 serologic features of NASH at 6 and 12 months.

  Month 0, Month 6, Month 12

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

  Months 0, Month 1, Month 3, Month 6, Month 9, Month 12

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

  Month 0, Month 6, Month 12

• Change in Month 0 Quality of Life at 12 months.

  Month 0, Month 12

Study Arms (1)

Patients with Obesity and NASH scheduled/recommended for P-ESG Procedure

OTHER

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

Diagnostic Test: Insulin Resistance; Behavioral: Quality of Life Assessment; Diagnostic Test: Liver Function Test; Diagnostic Test: Radiologic features of NASH; Diagnostic Test: Serologic features of NASH

Interventions

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

Patients with Obesity and NASH scheduled/recommended for P-ESG Procedure

Quality of Life Assessment BEHAVIORAL

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

Patients with Obesity and NASH scheduled/recommended for P-ESG Procedure

Liver Function Test DIAGNOSTIC_TEST

EUS-guided liver biopsy and portal pressure gradient measurement

Patients with Obesity and NASH scheduled/recommended for P-ESG Procedure

Radiologic features of NASH DIAGNOSTIC_TEST

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

Patients with Obesity and NASH scheduled/recommended for P-ESG Procedure

Serologic features of NASH DIAGNOSTIC_TEST

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

Patients with Obesity and NASH scheduled/recommended for P-ESG Procedure

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• American Society for Gastrointestinal Endoscopy: collaborator
• Boston Scientific Corporation: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Obesity; Liver Cirrhosis

Interventions

Liver Function Tests

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fibrosis; Pathologic Processes

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Pichamol Jirapinyo, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director of Bariatric Endoscopy

Model Details: Prospective pilot observational study

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 29, 2021
• Study Start: May 6, 2021
• Primary Completion (Estimated): December 24, 2026
• Study Completion (Estimated): December 24, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)