CompletedNot Applicable

Endoscopic Ultrasound Guided Liver Biopsy

United States40 participantsStarted 2017-08-01

Plain-language summary

This is a prospective study to determine the optimal technique for obtaining liver tissue with a smaller caliber (22 gauge) needle and whether a good core biopsy can be obtained without the use of suction and secondly to determine the diagnostic yield and safety of 22 g Fine Needle Biopsy needle for liver biopsy.

Who can participate

Age range19 Years

SexALL

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Inclusion criteria

✓. All patients referred to Florida Hospital Endoscopy Unit for assessment of elevated liver tests with EUS and are found to have no obstructive lesion to explain elevation of liver tests and will not require ERCP.
✓. Age ≥ 19 years
✓. Willing to provide informed consent verbal or written.

Exclusion criteria

✕. Age \<19 years
✕. Unable to safely undergo EUS for any reason
✕. Coagulopathy (INR \>1.6, Thrombocytopenia with platelet count \<50,000/ml) for subjects on anti-coagulation therapy.
✕. Unwilling or cognitively unable to provide informed consent verbal or written.
✕. Pregnancy (confirmed with Standard of Care urine pregnancy test for all women with child-bearing potential only)

What they're measuring

Diagnostic adequacy of the liver biopsy specimen

Timeframe: Sample obtained during EUS-guided liver biopsy.

Trial details

NCT IDNCT03307811

SponsorAdventHealth

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-06-19

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