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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
40
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.
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.
Geisinger Medical Center
Danville, Pennsylvania, United States
Pre-processing Length of the Longest Piece (LLP)
Pre-processing Length of the longest piece (LLP) measured in centimeter
Time frame: up to 5 days
Post-processing Length of the Longest Piece (LLP)
Post-processing Length of the longest piece (LLP) measured in centimeter
Time frame: 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
Time frame: 3-5 days
Pre-processing Aggregate Specimen Length (ASL)
Pre-processing Aggregate specimen length (ASL) measured in centimeter
Time frame: 3-5 days
Post-processing Aggregate Specimen Length (ASL)
Post-processing Aggregate specimen length (ASL) measured in centimeter
Time frame: 3-5 days
Portal Triads Number (Mean)
Number of portal triads (PT) in the specimen.
Time frame: 3-5 days
Portal Triads Quantity (Median)
Number of portal triads (PT) in the specimen.
Time frame: 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
Time frame: 3-5 days
No. of Fragments > 9 mm, Mean (SD)
No. of fragments \> 9 mm, mean (SD) Pre-processing Post-processing
Time frame: 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.
Time frame: 3-5 days
Length of Longest Piece
Time frame: Number Analyzed
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.