Comparison of 19g FNA and 19g FNB Needles for EUS-LB

Study Overview
=================
Brief Summary
-----------------
Chronic liver disorders (CLD) are a major cause of morbidity and mortality for individuals in the US. Though serologic analysis will often lead to a conclusive diagnosis, liver biopsy remains an important method for helping to determine the etiology and stage of LD. Percutaneous liver biopsy (PLB), transjugular liver biopsy (TLB) and surgical liver biopsy (SLB) are alternative methods for obtaining hepatic tissue. In recent years endoscopic ultrasound guided-liver biopsy (EUS-LB) has come to the forefront as a safe and effective method for obtaining tissue in CLD. There are several studies of the safety of EUS-LB as well as the adequacy of specimens obtained in this fashion. Most studies involve a 19-g needle, therefore in this study we hope to compare the tissue yields of a 19-g fine needle biopsy (FNB) needle, in comparison to conventional 19-g fine needle aspiration (FNA) needle. We predict that 19-g FNA and 19-g FNB needle will demonstrate similar diagnostic accuracy, with less visible blood artifact. Similarly, we predict the safety to be equal.

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

Conditions
-----------------
Abnormal Liver Function

Intervention / Treatment
-----------------
* Device: 19-gauge FNA needle
* Device: 19-gauge FNB needle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing EUS-LB Platelet count > 50,000 International normalized ratio (INR) < 1.5 Age > 18 years Non-pregnant patients Exclusion Criteria: Age < 18 years Pregnant patients Inability to obtain consent Anticoagulants or anti-platelet agents use (excluding aspirin) within the last 7-10 days Platelet count < 50,000 INR > 1.5 Presence of ascites Known liver cirrhosis Hemophilia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are assigned to one of two groups for the duration of the study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 19-gauge FNA needle<br>A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle. | Device: 19-gauge FNA needle<br>* A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.<br>|
| Active Comparator: 19-gauge FNB needle<br>A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle. | Device: 19-gauge FNB needle<br>* A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-processing Length of the Longest Piece (LLP) | Pre-processing Length of the longest piece (LLP) measured in centimeter | up to 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-processing Length of the Longest Piece (LLP) | Post-processing Length of the longest piece (LLP) measured in centimeter | 3-5 days | 
| Number of Participants With LLP Pre-processing Length Less Than 2 cm or Greater Than 2 cm | Pre-processing Length of the longest piece (LLP) subgroups: < 2 cm > 2cm | 3-5 days | 
| Pre-processing Aggregate Specimen Length (ASL) | Pre-processing Aggregate specimen length (ASL) measured in centimeter | 3-5 days | 
| Post-processing Aggregate Specimen Length (ASL) | Post-processing Aggregate specimen length (ASL) measured in centimeter | 3-5 days | 
| Portal Triads Number (Mean) | Number of portal triads (PT) in the specimen. | 3-5 days | 
| Portal Triads Quantity (Median) | Number of portal triads (PT) in the specimen. | 3-5 days | 
| Number of Participants With Fewer Than 11 Portal Triads or More Than 11 Portal Triads | Portal triads groups, n (%) < 11 Portal triads > 11 Portal triads | 3-5 days | 
| No. of Fragments > 9 mm, Mean (SD) | No. of fragments > 9 mm, mean (SD) Pre-processing Post-processing | 3-5 days | 
| Specimen Quality for Histologic Diagnosis | Number of cases for which a histologic diagnosis could be made based upon the amount of tissue obtained with the needle. | 3-5 days | 
| Length of Longest Piece |  | Number Analyzed | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FNB, liver biopsy, endoscopic ultrasound guided liver biopsy, FNA