N/A
Completed N=40
Comparison of 19g FNA and 19g FNB Needles for EUS-LB
Abnormal Liver Function
Source: ClinicalTrials.gov NCT03408171 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcomePrimary: Pre-processing Length of the Longest Piece (LLP) — 1.47; 2.09 centimeter
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pre-processing Length of the Longest Piece (LLP) |
1.47; 2.09 | — |
| SECONDARY Post-processing Length of the Longest Piece (LLP) |
1.05; 1.78 | — |
| SECONDARY Number of Participants With LLP Pre-processing Length Less Than 2 cm or Greater Than 2 cm |
17; 10; 3; 10 | — |
| SECONDARY Pre-processing Aggregate Specimen Length (ASL) |
10.89; 15.78 | — |
| SECONDARY Post-processing Aggregate Specimen Length (ASL) |
11.4; 15.32 | — |
| SECONDARY Portal Triads Number (Mean) |
18.1; 42.6 | — |
| SECONDARY Portal Triads Quantity (Median) |
16.5; 38 | — |
| SECONDARY Number of Participants With Fewer Than 11 Portal Triads or More Than 11 Portal Triads |
6; 2; 14; 18 | — |
| SECONDARY No. of Fragments > 9 mm, Mean (SD) |
3.5; 7.7; 1.1; 4.8 | — |
| SECONDARY Specimen Quality for Histologic Diagnosis |
20; 20 | — |
| SECONDARY Length of Longest Piece |
32.3; 30.2 | — |
Eligibility Criteria
Inclusion Criteria
- Patients undergoing EUS-LB
- Platelet count > 50,000
- International normalized ratio (INR) 18 years
- Non-pregnant patients
Exclusion Criteria
- Age 1.5
- Presence of ascites
- Known liver cirrhosis
- Hemophilia
Data sourced from ClinicalTrials.gov (NCT03408171). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.