- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04806607
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
Conditions
Intervention / Treatment
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.
Sponsor
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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