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

Not Applicable

Completed

• Conditions: Chronic Liver Disease

• 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

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