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

April 19, 2022 updated by: David L. Diehl, Geisinger Clinic

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

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

Study Overview

Status

Completed

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

42

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

    • 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 to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 19Gauge Fine Needle Biopsy
19Gauge Fine Needle
Biopsy specimen adequacy using the 19G FNB
Biopsy specimen adequacy using the 22G FNB.
Active Comparator: 22 Gauge Fine Needle Biopsy
22Gauge Fine Needle
Biopsy specimen adequacy using the 19G FNB
Biopsy specimen adequacy using the 22G FNB.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Longest Piece
Time Frame: Up to 5 Days
Length of the longest piece of the liver tissue obtained
Up to 5 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aggregate Specimen Length
Time Frame: 3 to 5 Days
Cumulative length of all the pieces of tissue obtained
3 to 5 Days
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 to 5 Days
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
3 to 5 Days
Adverse Events and Serious Adverse Events
Time Frame: 7 to 10 Days Post Procedure
Untoward, undesired, or unplanned event
7 to 10 Days Post Procedure

Collaborators and Investigators

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

Investigators

  • Principal Investigator: David L Diehl, MD, Geisinger Clinic

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)

April 30, 2021

Primary Completion (Actual)

March 16, 2022

Study Completion (Actual)

March 16, 2022

Study Registration Dates

First Submitted

March 17, 2021

First Submitted That Met QC Criteria

March 17, 2021

First Posted (Actual)

March 19, 2021

Study Record Updates

Last Update Posted (Actual)

April 20, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-1072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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