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Completed

NCT Number: NCT03408171

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • INR > 1.5
  • Presence of ascites
  • Known liver cirrhosis
  • Hemophilia

Treatment and study plan

19-gauge FNA needle

Device

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.

19-gauge FNB needle

Device

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.

Primary outcomes

  1. 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

  1. Post-processing Length of the Longest Piece (LLP)

    Time frame: 3-5 days

    Post-processing Length of the longest piece (LLP) measured in centimeter

  2. 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. Pre-processing Aggregate Specimen Length (ASL)

    Time frame: 3-5 days

    Pre-processing Aggregate specimen length (ASL) measured in centimeter

  4. Post-processing Aggregate Specimen Length (ASL)

    Time frame: 3-5 days

    Post-processing Aggregate specimen length (ASL) measured in centimeter

  5. Portal Triads Number (Mean)

    Time frame: 3-5 days

    Number of portal triads (PT) in the specimen.

  6. Portal Triads Quantity (Median)

    Time frame: 3-5 days

    Number of portal triads (PT) in the specimen.

  7. 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

  8. No. of Fragments > 9 mm, Mean (SD)

    Time frame: 3-5 days

    No. of fragments > 9 mm, mean (SD) Pre-processing Post-processing

  9. 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.

  10. Length of Longest Piece

    Time frame: Number Analyzed

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 23, 2018
Registry last updated
Apr 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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