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

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.

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Key information

Conditions

Obesity Body Weight Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease Non-alcoholic Steatohepatitis Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

22 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orbera Intragastric Balloon

Device

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 Biopsy

Procedure

Primary outcomes

Weight Loss Achieved With Intragastric Balloon (IGB)

Time frame: Baseline to 6 months post-procedure

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).

Secondary outcomes

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

Time frame: Baseline to 6 months post-procedure

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Combined Endoscopic Ultrasound Guided Core Liver Biopsy and Intragastric Balloon Placement for the Diagnosis and Management of Nonalcoholic Steatohepatitis and Obesity

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Aug 26, 2016
Registry last updated: Jun 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed