Effectiveness of Endoscopic Sleeve Gastroplasty in Nonalcoholic Fatty Liver Disease/Nonalcoholic Steatohepatitis

Last updated: March 10, 2025
Sponsor: West Virginia University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Disorders

Liver Disease

Primary Biliary Cholangitis

Treatment

Endoscopic Sleeve Gastroplasty

Clinical Study ID

NCT05507151
2202523300
  • Ages 18-75
  • All Genders

Study Summary

Endoscopic weight loss procedures, also termed endoscopic sleeve gastroplasty (ESG), has been proposed as a non-surgical procedure for managing obesity and offers a standard weight loss approach. Realizing there is a knowledge gap in applying ESG to morbidly obese patients with NAFLD, the investigators propose studying the efficacy of weight control and functional outcomes of ESG. This prospective pilot study is aimed to study the safety profiles, quality of life, and changes and improvements in the anthropometric, metabolic, and biochemical changes in these patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Body mass index (BMI) greater than 30 kg/m2, who are eligible for ESG

  • Patients scheduled to undergo an endoscopic bariatric weight loss procedure (ESG)

  • Patients older than 18 years and younger than 75 years of age at the time of consent

  • Patients able to provide written informed consent on the Institutional review board (IRB) approved informed consent form

  • Patients willing and able to comply with study requirements for follow-up

Exclusion

Exclusion criteria:

  • Patients who are treated with intragastric balloons

  • Family history of esophageal, gastric, or duodenal malignancy and active gastriculceration,

  • Pre-existing esophageal stenosis/stricture preventing the advancement of anendoscope during screening/baseline Esophagogastroduodenoscopy (EGD)

  • Presence of any gastric condition which required endoscopic surveillance (e.g.,known gastric intestinal metaplasia),

  • Known vascular abnormalities, obligate therapeutic anticoagulation, andpregnancy/lactation

  • Evidence of end-stage liver disease, including portal hypertension, ascites, andcoagulopathy

  • Positivity for hepatitis B virus or hepatitis C virus, current alcohol consumptionof more than 20 g/day in females and more than 30 g/day in males on average, use ofmedications with reported hepato-steatogenic effect (amiodarone, tamoxifen,estrogens), and drug-induced liver disease

  • Type 1 diabetes, Prior bariatric surgery, Autoimmune liver disease (antinuclearantibody titer >1/160), Wilson's disease, hemochromatosis, alpha1-antitrypsindeficiency,

  • Known positivity for human immunodeficiency virus, a concomitant disease withreduced life expectancy, severe psychiatric condition, drug dependence, or inabilityto provide informed consent.

  • The patient refuses or is unable to provide written informed consent

  • Prior bariatric treatment procedure

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Endoscopic Sleeve Gastroplasty
Phase:
Study Start date:
August 24, 2022
Estimated Completion Date:
May 31, 2026

Connect with a study center

  • West Virginia University

    Morgantown, West Virginia 26508
    United States

    Active - Recruiting

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