Comparison of 19g FNA and 19g FNB Needles for EUS-LB

April 1, 2020 updated by: Geisinger Clinic

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Device: 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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-processing Length of the Longest Piece (LLP)
Time Frame: 3-5 days
Post-processing Length of the longest piece (LLP) measured in centimeter
3-5 days
Number of Participants With LLP Pre-processing Length Less Than 2 cm or Greater Than 2 cm
Time Frame: 3-5 days

Pre-processing Length of the longest piece (LLP) subgroups:

< 2 cm > 2cm
3-5 days
Pre-processing Aggregate Specimen Length (ASL)
Time Frame: 3-5 days
Pre-processing Aggregate specimen length (ASL) measured in centimeter
3-5 days
Post-processing Aggregate Specimen Length (ASL)
Time Frame: 3-5 days
Post-processing Aggregate specimen length (ASL) measured in centimeter
3-5 days
Portal Triads Number (Mean)
Time Frame: 3-5 days
Number of portal triads (PT) in the specimen.
3-5 days
Portal Triads Quantity (Median)
Time Frame: 3-5 days
Number of portal triads (PT) in the specimen.
3-5 days
Number of Participants With Fewer Than 11 Portal Triads or More Than 11 Portal Triads
Time Frame: 3-5 days
Portal triads groups, n (%) < 11 Portal triads > 11 Portal triads
3-5 days
No. of Fragments > 9 mm, Mean (SD)
Time Frame: 3-5 days
No. of fragments > 9 mm, mean (SD) Pre-processing Post-processing
3-5 days
Specimen Quality for Histologic Diagnosis
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.
3-5 days
Length of Longest Piece
Time Frame: Number Analyzed
Number Analyzed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Geisinger Clinic

Investigators

  • Principal Investigator: David Diehl, MD, Geisinger Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2017

Primary Completion (Actual)

August 17, 2018

Study Completion (Actual)

August 17, 2018

Study Registration Dates

First Submitted

December 6, 2017

First Submitted That Met QC Criteria

January 16, 2018

First Posted (Actual)

January 23, 2018

Study Record Updates

Last Update Posted (Actual)

April 14, 2020

Last Update Submitted That Met QC Criteria

April 1, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2017-0391

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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