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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-03-13

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.

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Detailed Description

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Conditions

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Obesity Non-Alcoholic Steatohepatitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Single

All subjects will be receiving the Orbera Intragastric Balloon and will be undergoing Endoscopic Ultrasound guided core liver biopsy.

Group Type OTHER

Orbera Intragastric Balloon

Intervention Type 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

Intervention Type PROCEDURE

Interventions

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Orbera Intragastric Balloon

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.

Intervention Type DEVICE

Endoscopic Ultrasound Guided Core Liver Biopsy

Intervention Type PROCEDURE

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

Minimum Eligible Age

22 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No