Status:
UNKNOWN
Fine Needle Biopsy of Solid Pancreatic Mass Lesions
Lead Sponsor:
AdventHealth
Conditions:
Pancreatic Neoplasms
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a randomized trial to evaluate and directly compare the tissue quality, diagnostic sucess and safety profile of four different Fine Needle Biopsy needles.
Detailed Description
Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is currently the standard method for sampling solid pancreatic masses, with reported sensitivity for malignant cytology of 85-95%, specifi...
Eligibility Criteria
Inclusion
- All patients referred for EUS-guided tissue acquisition of suspected or confirmed solid pancreatic mass lesions visualized on any radiological imaging
- Able and willing to provide written or verbal consent
- ≥ 18 years old
- Able to undergo conscious sedation for EUS procedure
Exclusion
- \<18 years old
- Unable to obtain informed consent from the patient
- Medically unfit for sedation
- Pregnant patients
- No pancreatic mass lesions visualized on EUS
- Irreversible coagulopathy as determined by platelet count \< 50,000/microL or International Normalized Ratio (INR) \> 1.5
- Unable to stop anti-platelet agents prior to the procedure
Key Trial Info
Start Date :
September 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT04085055
Start Date
September 9 2019
End Date
December 1 2020
Last Update
August 5 2020
Active Locations (1)
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1
AdventHealth Orlando
Orlando, Florida, United States, 32803