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Completed

NCT Number: NCT04806607

19Gauge Fine Needle Biopsy (FNB) Versus 22Gauge FNB for Endoscopic Ultrasound Guided Liver Biopsy (EUS-LB)

To determine the adequacy of EUS-LB using a 19G core needle compared to a 22G core needle in a prospective randomized study.

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Key information

Conditions

Chronic Liver Disease

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

About this study

The 19Gauge core and 22Gauge core needles have both been used for EUS-LB with good success. Previous studies have reported good safety and tissue adequacy with both the needles, but the head-on comparison between these two needles is lacking.

This is a prospective randomized trial comparing the biopsy specimen adequacy of 19Gauge versus 22Gauge core needles for EUS-LB.

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 of age
  • Non-Pregnant Patients

Exclusion criteria

  • Age < 18 Years of Age
  • Pregnant Patients
  • Inability to obtain consent
  • Anticoagulants or anti-platelet agents (excluding aspirin) within the last 7 -10 days
  • Platelet count < 50,000
  • Presence of Ascites
  • Known Liver Cirrhosis

Treatment and study plan

19G FNB

Procedure

Biopsy specimen adequacy using the 19G FNB

22G FNB

Procedure

Biopsy specimen adequacy using the 22G FNB.

Primary outcomes

  1. Length of Longest Piece

    Time frame: Up to 5 Days

    Length of the longest piece of the liver tissue obtained

Secondary outcomes

  1. Aggregate Specimen Length

    Time frame: 3 to 5 Days

    Cumulative length of all the pieces of tissue obtained

  2. Degree of Fragmentation

    Time frame: 3 to 5 Days

    Size of the fragments of the samples will be measured, then classified as small (<5 mm), medium (5-8 mm) or large (>8 mm), then compared for the 2 needles

  3. Number of Portal Tracts in the Specimen

    Time frame: 3 to 5 Days

    Number of portal triads will be counted in the specimens and compared for the 2 needles

  4. Adverse Events and Serious Adverse Events

    Time frame: 7 to 10 Days Post Procedure

    Untoward, undesired, or unplanned event

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Registry information

Official study title

19Gauge Fine Needle Biopsy (FNB) Versus 22Gauge FNB for Endoscopic Ultrasound Guided Liver Biopsy (EUS-LB): A Randomized Prospective Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 19, 2021
Registry last updated
Apr 20, 2022

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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