Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
NCT Number: NCT03408171
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Danville, Pennsylvania, 17822, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: up to 5 days
Pre-processing Length of the longest piece (LLP) measured in centimeter
Time frame: 3-5 days
Post-processing Length of the longest piece (LLP) measured in centimeter
Time frame: 3-5 days
Pre-processing Length of the longest piece (LLP) subgroups:
< 2 cm > 2cm
Time frame: 3-5 days
Pre-processing Aggregate specimen length (ASL) measured in centimeter
Time frame: 3-5 days
Post-processing Aggregate specimen length (ASL) measured in centimeter
Time frame: 3-5 days
Number of portal triads (PT) in the specimen.
Time frame: 3-5 days
Number of portal triads (PT) in the specimen.
Time frame: 3-5 days
Portal triads groups, n (%) < 11 Portal triads > 11 Portal triads
Time frame: 3-5 days
No. of fragments > 9 mm, mean (SD) Pre-processing Post-processing
Time frame: 3-5 days
Number of cases for which a histologic diagnosis could be made based upon the amount of tissue obtained with the needle.
Time frame: Number Analyzed
Geisinger Clinic
Other
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
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