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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

Tracking Information
First Submitted Date  ICMJE March 17, 2021
First Posted Date  ICMJE March 19, 2021
Last Update Posted Date April 20, 2022
Actual Study Start Date  ICMJE April 30, 2021
Actual Primary Completion Date March 16, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2021)		 Length of Longest Piece [ Time Frame: Up to 5 Days ]
Length of the longest piece of the liver tissue obtained
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2021)
  • Aggregate Specimen Length [ Time Frame: 3 to 5 Days ]
    Cumulative length of all the pieces of tissue obtained
  • 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
  • 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
  • Adverse Events and Serious Adverse Events [ Time Frame: 7 to 10 Days Post Procedure ]
    Untoward, undesired, or unplanned event
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 19Gauge Fine Needle Biopsy (FNB) Versus 22Gauge FNB for Endoscopic Ultrasound Guided Liver Biopsy (EUS-LB)
Official Title  ICMJE 19Gauge Fine Needle Biopsy (FNB) Versus 22Gauge FNB for Endoscopic Ultrasound Guided Liver Biopsy (EUS-LB): A Randomized Prospective Trial
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Chronic Liver Disease
Intervention  ICMJE
  • Procedure: 19G FNB
    Biopsy specimen adequacy using the 19G FNB
  • Procedure: 22G FNB
    Biopsy specimen adequacy using the 22G FNB.
Study Arms  ICMJE
  • Active Comparator: 19Gauge Fine Needle Biopsy
    19Gauge Fine Needle
    Interventions:
    • Procedure: 19G FNB
    • Procedure: 22G FNB
  • Active Comparator: 22 Gauge Fine Needle Biopsy
    22Gauge Fine Needle
    Interventions:
    • Procedure: 19G FNB
    • Procedure: 22G FNB
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 17, 2021)		 42
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 16, 2022
Actual Primary Completion Date March 16, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04806607
Other Study ID Numbers  ICMJE 2020-1072
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party David L. Diehl, Geisinger Clinic
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Geisinger Clinic
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David L Diehl, MD Geisinger Clinic
PRS Account Geisinger Clinic
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP