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

Mayo Clinic

Status: Completed

Conditions: Obesity; Non-Alcoholic Steatohepatitis

Treatments: Procedure: Endoscopic Ultrasound Guided Core Liver Biopsy; Device: Orbera Intragastric Balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT02880189

15-009262

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 22 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Single

Other group

Description:

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

Treatment:

Device: Orbera Intragastric Balloon

Procedure: Endoscopic Ultrasound Guided Core Liver Biopsy