Back to results19Gauge Fine Needle Biopsy (FNB) Versus 22Gauge FNB for Endoscopic Ultrasound Guided Liver Biopsy (EUS-LB)
Primary Purpose
Chronic Liver Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
19G FNB
22G FNB
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Liver Disease
Eligibility 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
Sites / Locations
- Geisinger Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
19Gauge Fine Needle Biopsy
22 Gauge Fine Needle Biopsy
Arm Description
19Gauge Fine Needle
22Gauge Fine Needle
Outcomes
Primary Outcome Measures
Length of Longest Piece
Length of the longest piece of the liver tissue obtained
Secondary Outcome Measures
Aggregate Specimen Length
Cumulative length of all the pieces of tissue obtained
Degree of Fragmentation
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
Number of portal triads will be counted in the specimens and compared for the 2 needles
Adverse Events and Serious Adverse Events
Untoward, undesired, or unplanned event
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04806607
Brief Title
19Gauge Fine Needle Biopsy (FNB) Versus 22Gauge FNB for Endoscopic Ultrasound Guided Liver Biopsy (EUS-LB)
Official Title
19Gauge Fine Needle Biopsy (FNB) Versus 22Gauge FNB for Endoscopic Ultrasound Guided Liver Biopsy (EUS-LB): A Randomized Prospective Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 30, 2021 (Actual)
Primary Completion Date
March 16, 2022 (Actual)
Study Completion Date
March 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Geisinger Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Liver Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
19Gauge Fine Needle Biopsy
Arm Type
Active Comparator
Arm Description
19Gauge Fine Needle
Arm Title
22 Gauge Fine Needle Biopsy
Arm Type
Active Comparator
Arm Description
22Gauge Fine Needle
Intervention Type
Procedure
Intervention Name(s)
19G FNB
Intervention Description
Biopsy specimen adequacy using the 19G FNB
Intervention Type
Procedure
Intervention Name(s)
22G FNB
Intervention Description
Biopsy specimen adequacy using the 22G FNB.
Primary Outcome Measure Information:
Title
Length of Longest Piece
Description
Length of the longest piece of the liver tissue obtained
Time Frame
Up to 5 Days
Secondary Outcome Measure Information:
Title
Aggregate Specimen Length
Description
Cumulative length of all the pieces of tissue obtained
Time Frame
3 to 5 Days
Title
Degree of Fragmentation
Description
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
Time Frame
3 to 5 Days
Title
Number of Portal Tracts in the Specimen
Description
Number of portal triads will be counted in the specimens and compared for the 2 needles
Time Frame
3 to 5 Days
Title
Adverse Events and Serious Adverse Events
Description
Untoward, undesired, or unplanned event
Time Frame
7 to 10 Days Post Procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David L Diehl, MD
Organizational Affiliation
Geisinger Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
19Gauge Fine Needle Biopsy (FNB) Versus 22Gauge FNB for Endoscopic Ultrasound Guided Liver Biopsy (EUS-LB)
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