A Physiologic Analysis of Endoscopic Sleeve Gastroplasty (ESG)
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
🗓️ Study Start (Actual) 6 May 2021
🗓️ Primary Completion (Estimated) February 2024
✅ Study Completion (Estimated) July 2024
👥 Enrollment (Estimated) 12
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 17 March 2021
  • First Submitted that Met QC Criteria 25 March 2021
  • First Posted 29 March 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 14 November 2023
  • Last Update Posted 18 November 2023
  • Last Verified November 2023