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

Not Applicable

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
19-gauge FNB needle	19-gauge FNB needle	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.
19-gauge FNA needle	19-gauge FNA needle	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.

Primary Outcome Measures

Name	Time	Method
Pre-processing Length of the Longest Piece (LLP)	up to 5 days	Pre-processing Length of the longest piece (LLP) measured in centimeter

Secondary Outcome Measures

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