Endoscopic Ultrasound vs Percutaneous Route for Liver Biopsy

Completed · Not applicable

Conditions studied: Liver Biopsy

In brief

This study is to evaluate and directly compare the technical success, tissue quality, diagnostic efficacy and safety profile of Percutaneous and Endoscopic Ultrasound-guided Liver Biopsy.

Key facts

Study ID

NCT04003766

Run by

AdventHealth

People needed

40

Starts

2019-07-25

Expected to finish

2022-02-11

Last updated by the study team

2022-02-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients referred for liver biopsy for any reason
• Informed consent obtained from the patient
• ≥ 18 years old
• Able to undergo conscious sedation for EUS procedure

You may not qualify if…

• <18 years old
• Unable to obtain informed consent from the patient
• Medically unfit for sedation
• Pregnant patients
• Presence of a mass lesion in the liver requiring biopsy visualized on cross-sectional imaging
• Irreversible coagulopathy as determined by platelet count < 50,000 mm3 or International Normalized Ratio (INR) > 1.5
• Unable to stop anticoagulation or anti-platelet therapy for 5 days prior to the procedure
• Hemophilia
• Presence of an alternative etiology for elevated liver tests seen during liver biopsy, e.g. choledocholithiasis discovered during EUS examination

Where it is running

• Center for Interventional Endoscopy — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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