Status:
COMPLETED
EUS-FNB With ROSE Vs. EUS-FNB Without ROSE
Lead Sponsor:
Azienda Ospedaliera Universitaria Integrata Verona
Conditions:
Biopsy, Fine-needle
Pancreatic Neoplasm
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Rationale: Rapid on-Site Evaluation (ROSE) of cytologic specimens acquired with EUS-guided fine needle aspiration (EUS-FNA) represents the most accurate available technique to reach a definitive diagn...
Detailed Description
Since its initial report in 1992, endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) has become an increasingly important tool for the evaluation of lesions of the gastro-intestinal tract a...
Eligibility Criteria
Inclusion
- Solid pancreatic mass referred for EUS-guided tissue acquisition
- Lesion can be visualized with EUS and needle puncturing can be technically feasible
- Written informed consent.
Exclusion
- Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma (FFP)
- Use of anticoagulants that cannot be discontinued
- International Normalized Ratio (INR) \>1.5 or platelet count \<50.000
- Cystic lesions even with solid component
- Previous inclusion in other or present study
- Pregnancy
Key Trial Info
Start Date :
March 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2020
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT03322592
Start Date
March 29 2018
End Date
July 30 2020
Last Update
September 30 2020
Active Locations (13)
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1
University of Virginia Health Sciences Center
Charlottesville, Virginia, United States, 22901
2
Royal Adelaide Hospital
Adelaide, Australia
3
Cliniques Universitaires St-Luc
Brussels, Belgium
4
Istituto Humanitas
Milan, Italy