EUS Guided Core Liver Biopsy and IGB Placement for the Diagnosis and Management of NASH and Obesity

Mayo Clinic21 enrolled

Overview

This study is designed to investigate the impact of weight loss achieved with the IGB on NASH with early fibrosis in a select cohort of patients with obesity preselected to have a high pre-test probability of having NASH with early fibrosis based on magnetic resonance elastography (MRE)-Hepatogram. In addition, this study will explore potential non-invasive imaging criteria for NASH and early fibrosis using EUS-Elastography.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Obesity Non-Alcoholic Steatohepatitis

Interventions

Orbera Intragastric BalloonDEVICE

The Orbera Intragastric Balloon will be placed in the stomach endoscopically through a catheter under conscious sedation. The procedure takes about 20 minutes to complete. The balloon will stay in place for 6 months and then it will be removed endoscopically.

Endoscopic Ultrasound Guided Core Liver BiopsyPROCEDURE

Eligibility

Sex: ALLMin age: 22 YearsMax age: 69 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients diagnosed with Non-alcoholic Steatohepatitis with early evidence of fibrosis as seen on MRE-hepatogram * Referred clinically for an intragastric balloon placement for weight loss Exclusion Criteria: * Women who are pregnant or plan to be pregnant or are breastfeeding * Previous history of gastric surgery * Current or recent (within 6 months) gastric or duodenal ulcers * Gastroparesis * Liver cirrhosis * Coagulopathy or active use of coagulation * Inability to provide a written informed consent

Outcomes

Primary Outcomes

Weight Loss Achieved With Intragastric Balloon (IGB)

Total number of subjects with two points or greater improvement on objective Non-alcoholic Steatohepatitis (NASH) histopathological parameters. The NAS scale can range from 0 to 8 and is calculated by the sum of scores of steatosis (0-3), lobular inflammation (0-3) and hepatocyte ballooning (0-2).

Time frame: Baseline to 6 months post-procedure

Secondary Outcomes

Diagnosis of NASH and Early Fibrosis by Endoscopic Ultrasound (EUS) Guided Liver Core Biopsies

Total number of subjects correctly diagnosed with NASH and Early Fibrosis by EUS guided core liver biopsies

Time frame: Baseline to 6 months post-procedure

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.