19Gauge Fine Needle Biopsy (FNB) Versus 22Gauge FNB for Endoscopic Ultrasound Guided Liver Biopsy (EUS-LB)
1 other identifier
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2021
CompletedFirst Posted
Study publicly available on registry
March 19, 2021
CompletedStudy Start
First participant enrolled
April 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 16, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 16, 2022
CompletedApril 20, 2022
April 1, 2022
11 months
March 17, 2021
April 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Length of Longest Piece
Length of the longest piece of the liver tissue obtained
Up to 5 Days
Secondary Outcomes (4)
Aggregate Specimen Length
3 to 5 Days
Degree of Fragmentation
3 to 5 Days
Number of Portal Tracts in the Specimen
3 to 5 Days
Adverse Events and Serious Adverse Events
7 to 10 Days Post Procedure
Study Arms (2)
19Gauge Fine Needle Biopsy
ACTIVE COMPARATOR19Gauge Fine Needle
22 Gauge Fine Needle Biopsy
ACTIVE COMPARATOR22Gauge Fine Needle
Interventions
Eligibility Criteria
You may qualify if:
- Patients undergoing EUS-LB
- Platelet Count \> 50,000
- International normalized ratio (INR) \< 1.5
- Age \> 18 years of age
- Non-Pregnant Patients
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Geisinger Cliniclead
Study Sites (1)
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Related Publications (1)
Diehl DL, Sangwan V, Johal AS, Khara HS, Confer B. Comparing a 19-gauge fine-needle biopsy needle with a 22-gauge fine-needle biopsy needle for EUS-guided liver biopsy sampling: a prospective randomized study. Gastrointest Endosc. 2024 Jun;99(6):931-937. doi: 10.1016/j.gie.2023.12.022. Epub 2023 Dec 21.
PMID: 38141686DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
David L Diehl, MD
Geisinger Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 17, 2021
First Posted
March 19, 2021
Study Start
April 30, 2021
Primary Completion
March 16, 2022
Study Completion
March 16, 2022
Last Updated
April 20, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share