Status:
RECRUITING
Evaluation of Pancreatic Cystic Lesions Via EUS-guided Fine Needle Aspiration With and Without Micro Forceps Biopsies
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
US Endoscopy
Conditions:
Pancreatic Cyst
Eligibility:
All Genders
18-89 years
Phase:
NA
Brief Summary
Pancreatic cystic lesions (PCLs) are a common incidental finding in cross sectional imaging (up to 27% on CT scan and 41% on MRI) and pose a management challenge to physicians. According to society gu...
Detailed Description
Pancreatic cystic lesions (PCLs) are a common incidental finding in cross sectional imaging (up to 27% on CT scan and 41% on MRI) and pose a management challenge to physicians. According to society gu...
Eligibility Criteria
Inclusion
- Adult patients \>18 years old
- Cysts \> 20 mm in size deemed appropriate for FNA by the endoscopist, based on clinical presentation, radiologic imaging features, associated solid mass or nodules, and patient anxiety about the diagnosis
Exclusion
- Age \<18 years
- Inability to provide informed consent
- Thrombocytopenia (Platelets \< 50,000) or coagulopathy (INR \> 1.8)
- Pregnancy
- Post-surgical anatomy where the cyst is not accessible for FNA
- EUS findings suggesting that cyst FNA would be unsafe (e.g. intervening blood vessels)
- EUS appearance suggesting FNA is not indicated (e.g. cyst smaller than prior radiologic imaging, cyst not seen, EUS suggestive of serous cystadenoma)
Key Trial Info
Start Date :
May 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04404101
Start Date
May 11 2021
End Date
April 1 2025
Last Update
May 21 2024
Active Locations (3)
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1
University of California Irvine
Irvine, California, United States, 92697
2
University of Colorado - Anschutz Medical Campus
Aurora, Colorado, United States, 80045
3
Baylor College of Medicine
Houston, Texas, United States, 77030