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

Not Applicable

Completed

• Conditions: Chronic Liver Disease
• Interventions: Procedure: 19G FNB; Procedure: 22G FNB

• Registration Number: NCT04806607
• Lead Sponsor: Geisinger Clinic

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-03-17
• Study First Submitted QC: 2021-03-17
• Study First Posted: 2021-03-19
• Study Start: 2021-04-30
• Primary Completion: 2022-03-16
• Study Completion: 2022-03-16
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
19Gauge Fine Needle Biopsy	22G FNB	19Gauge Fine Needle
22 Gauge Fine Needle Biopsy	22G FNB	22Gauge Fine Needle
19Gauge Fine Needle Biopsy	19G FNB	19Gauge Fine Needle
22 Gauge Fine Needle Biopsy	19G FNB	22Gauge Fine Needle

Primary Outcome Measures

Name	Time	Method
Length of Longest Piece	Up to 5 Days	Length of the longest piece of the liver tissue obtained

Secondary Outcome Measures

Name	Time	Method
Adverse Events and Serious Adverse Events	7 to 10 Days Post Procedure	Untoward, undesired, or unplanned event
Aggregate Specimen Length	3 to 5 Days	Cumulative length of all the pieces of tissue obtained
Degree of Fragmentation	3 to 5 Days	Size of the fragments of the samples will be measured, then classified as small (\<5 mm), medium (5-8 mm) or large (\>8 mm), then compared for the 2 needles
Number of Portal Tracts in the Specimen	3 to 5 Days	Number of portal triads will be counted in the specimens and compared for the 2 needles

Trial Locations

Locations (1)

Geisinger Medical Center; 🇺🇸 Danville, Pennsylvania, United States