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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02880189
• Other study ID #: 15-009262
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: March 13, 2018

Study information

• Verified date: June 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 13, 2018
• Est. primary completion date: March 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Non-Alcoholic Steatohepatitis
• Obesity

Intervention

Device:
• 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.

Procedure:
• Endoscopic Ultrasound Guided Core Liver Biopsy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Mayo Clinic Clinical Trials