19Gauge Fine Needle Biopsy (FNB) Versus 22Gauge FNB for Endoscopic Ultrasound Guided Liver Biopsy (EUS-LB)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-30

Study Completion Date

2022-03-16

Brief Summary

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To determine the adequacy of EUS-LB using a 19G core needle compared to a 22G core needle in a prospective randomized study.

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Detailed Description

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The 19Gauge core and 22Gauge core needles have both been used for EUS-LB with good success. Previous studies have reported good safety and tissue adequacy with both the needles, but the head-on comparison between these two needles is lacking.

This is a prospective randomized trial comparing the biopsy specimen adequacy of 19Gauge versus 22Gauge core needles for EUS-LB.

Conditions

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Chronic Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a prospective randomized trial comparing the biopsy specimen adequacy of 19G versus 22G core needles in subjects undergoing an EUS-LB.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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19Gauge Fine Needle Biopsy

19Gauge Fine Needle

Group Type ACTIVE_COMPARATOR

19G FNB

Intervention Type PROCEDURE

Biopsy specimen adequacy using the 19G FNB

22G FNB

Intervention Type PROCEDURE

Biopsy specimen adequacy using the 22G FNB.

22 Gauge Fine Needle Biopsy

22Gauge Fine Needle

Group Type ACTIVE_COMPARATOR

19G FNB

Intervention Type PROCEDURE

Biopsy specimen adequacy using the 19G FNB

22G FNB

Intervention Type PROCEDURE

Biopsy specimen adequacy using the 22G FNB.

Interventions

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19G FNB

Biopsy specimen adequacy using the 19G FNB

Intervention Type PROCEDURE

22G FNB

Biopsy specimen adequacy using the 22G FNB.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing EUS-LB
* Platelet Count \> 50,000
* International normalized ratio (INR) \< 1.5
* Age \> 18 years of age
* Non-Pregnant Patients

Exclusion Criteria

* Age \< 18 Years of Age
* Pregnant Patients
* Inability to obtain consent
* Anticoagulants or anti-platelet agents (excluding aspirin) within the last 7 -10 days
* Platelet count \< 50,000
* Presence of Ascites
* Known Liver Cirrhosis

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No