Clinical Trials

Evaluation of PCLs Using Three EUS-FNA Needles

Location:

Jacksonville,  FL,  Scottsdale and Phoenix,  AZ

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: 03/28/2013

NCT ID: NCT01711294