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

Study Overview
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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.

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.

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

Conditions
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Chronic Liver Disease

Intervention / Treatment
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* Procedure: 19G FNB
* Procedure: 22G FNB


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a prospective randomized trial comparing the biopsy specimen adequacy of 19G versus 22G core needles in subjects undergoing an EUS-LB.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 19Gauge Fine Needle Biopsy<br>19Gauge Fine Needle | Procedure: 19G FNB<br>* Biopsy specimen adequacy using the 19G FNB<br>Procedure: 22G FNB<br>* Biopsy specimen adequacy using the 22G FNB.<br>|
| Active Comparator: 22 Gauge Fine Needle Biopsy<br>22Gauge Fine Needle | Procedure: 19G FNB<br>* Biopsy specimen adequacy using the 19G FNB<br>Procedure: 22G FNB<br>* Biopsy specimen adequacy using the 22G FNB.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Longest Piece | Length of the longest piece of the liver tissue obtained | Up to 5 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aggregate Specimen Length | Cumulative length of all the pieces of tissue obtained | 3 to 5 Days | 
| 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 | 
| 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 | 
| Adverse Events and Serious Adverse Events | Untoward, undesired, or unplanned event | 7 to 10 Days Post Procedure |