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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Geisinger Clinic
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Pre-processing Length of the Longest Piece (LLP)
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Presence of ascites
- •Known liver cirrhosis
Arms & Interventions
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.
Intervention: 19-gauge FNA needle (Device)
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.
Intervention: 19-gauge FNB needle (Device)
Outcomes
Primary Outcomes
Pre-processing Length of the Longest Piece (LLP)
Time Frame: up to 5 days
Pre-processing Length of the longest piece (LLP) measured in centimeter
Secondary Outcomes
- Portal Triads Quantity (Median)(3-5 days)
- Post-processing Length of the Longest Piece (LLP)(3-5 days)
- Number of Participants With LLP Pre-processing Length Less Than 2 cm or Greater Than 2 cm(3-5 days)
- Pre-processing Aggregate Specimen Length (ASL)(3-5 days)
- No. of Fragments > 9 mm, Mean (SD)(3-5 days)
- Specimen Quality for Histologic Diagnosis(3-5 days)
- Length of Longest Piece(Number Analyzed)
- Post-processing Aggregate Specimen Length (ASL)(3-5 days)
- Portal Triads Number (Mean)(3-5 days)
- Number of Participants With Fewer Than 11 Portal Triads or More Than 11 Portal Triads(3-5 days)