Clinical trial NCT03408171: Comparison of 19g FNA and 19g FNB Needles for EUS-LB
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abnormal Liver Function
Keywords: liver biopsy
endoscopic ultrasound guided liver biopsy
FNA
FNB
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two groups for the duration of the study.
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

1. Patients undergoing EUS-LB
2. Platelet count \> 50,000
3. International normalized ratio (INR) \< 1.5
4. Age \> 18 years
5. Non-pregnant patients

Exclusion Criteria:

1. Age \< 18 years
2. Pregnant patients
3. Inability to obtain consent
4. Anticoagulants or anti-platelet agents use (excluding aspirin) within the last 7-10 days
5. Platelet count \< 50,000
6. INR \> 1.5
7. Presence of ascites
8. Known liver cirrhosis
9. Hemophilia

Primary outcomes:
measure: Pre-processing Length of the Longest Piece (LLP)
timeFrame: up to 5 days
Secondary outcomes:
measure: Post-processing Length of the Longest Piece (LLP)
timeFrame: 3-5 days
measure: Number of Participants With LLP Pre-processing Length Less Than 2 cm or Greater Than 2 cm
timeFrame: 3-5 days
measure: Pre-processing Aggregate Specimen Length (ASL)
timeFrame: 3-5 days
measure: Post-processing Aggregate Specimen Length (ASL)
timeFrame: 3-5 days
measure: Portal Triads Number (Mean)
timeFrame: 3-5 days
measure: Portal Triads Quantity (Median)
timeFrame: 3-5 days
measure: Number of Participants With Fewer Than 11 Portal Triads or More Than 11 Portal Triads
timeFrame: 3-5 days
measure: No. of Fragments > 9 mm, Mean (SD)
timeFrame: 3-5 days
measure: Specimen Quality for Histologic Diagnosis
timeFrame: 3-5 days
measure: Length of Longest Piece
timeFrame: Number Analyzed
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: David Diehl, MD
role: PRINCIPAL_INVESTIGATOR
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