A Multicenter, Prospective, Randomized Study on Endosonographic Evaluation of Pancreatic Cystic Lesions Using 22 G, 19 G, and Flexible 19 G Fine Needle Aspiration
Jacksonville, Fla., Phoenix/Scottsdale, Ariz.
Trial status: Open for Enrollment
Why is this study being done?
To document impact of EUS-FNA needle size and flexibility on effectiveness of pancreatic cystic lesions (PCL) aspiration, on ability to obtain sufficient material for standard diagnostic testing, and on diagnostic accuracy of EUS-FNA aspirate for differentiation of mucinous (pre-malignant) and non-mucinous cysts.
Who is eligible to participate?
- Pancreatic cystic lesion measuring 13mm or greater in largest diameter.
- Indicated for EUS evaluation of the PCL including EUS-FNA.
- Age 18 years of age or older.
- Willing and able to comply with the study procedures and provide written informed consent form to participate in the study.
- Cysts in which FNA is not indicated based on review by the clinician, including potential concern of blood vessel location relative to the cyst.
- Requirement for anticoagulation using clopidogril, warfarin, or other long acting antiplatelet agents (with the exception of aspirin) that cannot be safely stopped according to institutional guidelines.
- Standard contraindications for EUS.
- Known pancreatic pseudocyst.