CompletedNot Applicable

Evaluation of PCLs Using Three EUS-FNA Needles

United States250 participantsStarted 2013-01-08

Plain-language summary

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 can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 according to institutional guidelines. * Standard contraindications for EUS. * Known pancreatic pseudocyst. * Pregnancy.

What they're measuring

Volume of Aspirated Cyst Fluid as a Function of Estimated Maximal Volume

Timeframe: At procedure (Up to 1 hour)

Trial details

NCT IDNCT01711294

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-06-06

Results submitted2020-10-20

View on ClinicalTrials.gov More Pancreatic Cystic Lesions trials