NCT01663493CompletedNot Applicable
Randomized Trial Comparing 2 Needles During EUS-FNA of Solid Pancreatic Masses
Brigham and Women's Hospital1 site in 1 country59 target enrollmentStarted: October 1, 2015Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 59
- Locations
- 1
- Primary Endpoint
- number of passes
Study Overview
Brief Summary
This study will examine whether there is any difference in number of passes needed to diagnose pancreatic masses during endoscopic ultrasound-guided biopsies using 2 different types of needles.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •pancreas mass
Exclusion Criteria
- •coagulopathy
- •mass not approachable by endoscopic ultrasound biopsy
Arms & Interventions
Fine needle aspiration needle
Other
standard Beacon FNA needle
Intervention: FNB (Procedure)
fine needle biopsy needle
Other
SharkCore fine needle biopsy needle
Intervention: FNB (Procedure)
Outcomes
Primary Outcomes
number of passes
Time Frame: 1 week
Secondary Outcomes
No secondary outcomes reported
Investigators
Linda S. Lee
Assistant Professor of Medicine
Brigham and Women's Hospital
Study Sites (1)
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