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NCT04806607 Clinical Trial

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

Chronic Liver Disease Clinical Trial

Official title:
19Gauge Fine Needle Biopsy (FNB) Versus 22Gauge FNB for Endoscopic Ultrasound Guided Liver Biopsy (EUS-LB): A Randomized Prospective Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04806607
Other study ID # 2020-1072
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 30, 2021
Est. completion date March 16, 2022

Study information
Verified date April 2022
Source Geisinger Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 42
Est. completion date March 16, 2022
Est. primary completion date March 16, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 89 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• 19G FNB
Biopsy specimen adequacy using the 19G FNB
• 22G FNB
Biopsy specimen adequacy using the 22G FNB.

Locations
Country Name City State
United States Geisinger Medical Center Danville Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Geisinger Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Length of Longest Piece Length of the longest piece of the liver tissue obtained Up to 5 Days
Secondary Aggregate Specimen Length Cumulative length of all the pieces of tissue obtained 3 to 5 Days
Secondary Degree of Fragmentation 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 3 to 5 Days
Secondary Number of Portal Tracts in the Specimen Number of portal triads will be counted in the specimens and compared for the 2 needles 3 to 5 Days
Secondary Adverse Events and Serious Adverse Events Untoward, undesired, or unplanned event 7 to 10 Days Post Procedure
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