NCT04687410UnknownNot Applicable
Randomized Comparison of Tissue Quality and Molecular Yield Between a Novel Crown-cut Biopsy Needle (FNB) and a Standard Aspiration Needle (FNA) for EUS Guided Diagnosis of Solid Pancreatic Lesions
Peter Vilmann MD, DSc, HC, FASGE2 sites in 1 country68 target enrollmentStarted: June 15, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 68
- Locations
- 2
- Primary Endpoint
- Amount of tissue micro-fragments
Study Overview
Brief Summary
The aim of this study is to compare tissue quality and molecular yield between a novel crown-cut biopsy needle (FNB) and a standard aspiration needle (FNA) for EUS-guided diagnosis of solid pancreatic lesions.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients with a newly discovered SPL scheduled for EUS-guided tissue acquisition who can understand and provide a written consent.
Exclusion Criteria
- •Patients with uncorrected coagulopathies (INR >1.5 or platelet count <50,000) or patients treated with anticoagulants that cannot be discontinued.
- •Pregnant or lactating females.
- •Interposed, large vessels between the transducer and the target lesion.
Outcomes
Primary Outcomes
Amount of tissue micro-fragments
Time Frame: 1 month
Comparison of median number of tissue micro-fragments
Total tissue area
Time Frame: 1 month
Comparison of total total tissue area in um2
Diagnostic tissue area
Time Frame: 1 month
Comparison of total diagnostic tissue area in um2
Secondary Outcomes
- Suitability for molecular analyses(6 months)
- Diagnostic yield(1 month)
- Diagnostic performance(12 month)
- Mean DNA concentration(6 months)
- Adverse event rate(1 month)
Investigators
Peter Vilmann MD, DSc, HC, FASGE
Professor
Herlev Hospital
Study Sites (2)
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