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

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity, Non-Alcoholic Steatohepatitis

Intervention / Treatment
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* Device: Orbera Intragastric Balloon
* Procedure: Endoscopic Ultrasound Guided Core Liver Biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single<br>All subjects will be receiving the Orbera Intragastric Balloon and will be undergoing Endoscopic Ultrasound guided core liver biopsy. | Device: Orbera Intragastric Balloon<br>* 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.<br>Procedure: Endoscopic Ultrasound Guided Core Liver Biopsy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline to 6 months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline to 6 months post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-Alcoholic Steatohepatitis (NASH), NASH with Fibrosis, Intragastric Balloon, Orbera, Orbera Intragastric Balloon