We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04806607
Recruitment Status : Completed
First Posted : March 19, 2021
Last Update Posted : April 20, 2022
Sponsor:
Information provided by (Responsible Party):
David L. Diehl, Geisinger Clinic

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
To determine the adequacy of EUS-LB using a 19G core needle compared to a 22G core needle in a prospective randomized study.

Condition or disease Intervention/treatment Phase
Chronic Liver Disease Procedure: 19G FNB Procedure: 22G FNB Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a prospective randomized trial comparing the biopsy specimen adequacy of 19G versus 22G core needles in subjects undergoing an EUS-LB.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 19Gauge Fine Needle Biopsy (FNB) Versus 22Gauge FNB for Endoscopic Ultrasound Guided Liver Biopsy (EUS-LB): A Randomized Prospective Trial
Actual Study Start Date : April 30, 2021
Actual Primary Completion Date : March 16, 2022
Actual Study Completion Date : March 16, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: 19Gauge Fine Needle Biopsy
19Gauge Fine Needle
 Procedure: 19G FNB
Biopsy specimen adequacy using the 19G FNB

Procedure: 22G FNB
Biopsy specimen adequacy using the 22G FNB.
Active Comparator: 22 Gauge Fine Needle Biopsy
22Gauge Fine Needle
 Procedure: 19G FNB
Biopsy specimen adequacy using the 19G FNB

Procedure: 22G FNB
Biopsy specimen adequacy using the 22G FNB.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Length of Longest Piece [ Time Frame: Up to 5 Days ]
    Length of the longest piece of the liver tissue obtained


Secondary Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04806607


Locations
Layout table for location information
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Sponsors and Collaborators
Geisinger Clinic
Investigators
Layout table for investigator information
Principal Investigator: David L Diehl, MD Geisinger Clinic
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: David L. Diehl, Principal Investigator, Geisinger Clinic
ClinicalTrials.gov Identifier: NCT04806607    
Other Study ID Numbers: 2020-1072
First Posted: March 19, 2021    Key Record Dates
Last Update Posted: April 20, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Diseases
Digestive System Diseases