Status:
COMPLETED
Connect Your Needle to Your Phone to Increase EUS FNA Diagnostic Yield?
Lead Sponsor:
Carol Davila University of Medicine and Pharmacy
Conditions:
Pancreatic Neoplasms
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Summary Endoscopic ultrasound fine needle aspiration (EUS FNA) is an established and recommended technique for diagnostic of solid pancreatic masses. The accuracy of the technique depends on the oper...
Detailed Description
Research questions and aims The investigators hypothesize that during a EUS FNA (endoscopic ultrasound fine needle aspiration) procedure, the acceleration of the needle that travels through tissue du...
Eligibility Criteria
Inclusion
- a solid pancreatic lesion with diameter larger than 20mm, with or without a cystic component, with unknown histology;
- age above 18 years old;
- signed informed consent;
Exclusion
- a solid pancreatic mass with a diameter less than 20mm or with known histology;
- a cystic pancreatic mass, without a solid component;
- coagulation disorder (international normalized ratio above 1.5, activated partial thromboplastin time above 42 seconds, platelet count less than 60000/mmc) or impossibility to stop antiaggregants or anticoagulants according to the European Society of Digestive Endoscopy guidelines;
- European Cooperative Oncology Group status 4;
- American Society of Anesthesiology score higher than 3;
- pregnant women;
- age under 18 years old;
- refusal or impossibility to sign informed consent.
Key Trial Info
Start Date :
July 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2020
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT03303352
Start Date
July 24 2017
End Date
January 30 2020
Last Update
January 31 2020
Active Locations (3)
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1
"Prof. Dr. Agrippa Ionescu" Clinical and Emerency Hospital
Bucharest, Romania, 0112013
2
Floreasca Emergency Hospital
Bucharest, Romania, 014471
3
Colentina Clinical Hospital
Bucharest, Romania, 020125