A Multicenter, Prospective, Randomized Study on Endosonographic Evaluation of Pancreatic Cystic Lesions Using 22 G, 19 G, and Flexible 19 G Fine Needle Aspiration

Location:

Phoenix/Scottsdale, AZ., Jacksonville, FL.

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) drainage, 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?

Inclusion Criteria: - 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. Exclusion Criteria: - 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 at least 7 days prior to the procedure. - Platelet count < 50,000/microliter. - International normalized ratio (INR) > 1.5. - Standard contraindications for EUS. - Known pancreatic pseudocyst. - Pregnancy.

Last updated:

3/28/2013

NCT ID:

NCT01711294