Evaluation of PCLs Using Three EUS-FNA Needles

Completed · Not applicable

Conditions studied: Pancreatic Cystic Lesions

In brief

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.

Key facts

Study ID

NCT01711294

Run by

Boston Scientific Corporation

People needed

250

Starts

2013-01-08

Expected to finish

2019-12-18

Last updated by the study team

2021-01-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Mayo Clinic — Scottsdale, Arizona, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Indiana University Medical Center — Indianapolis, Indiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• New York Presbyterian Hospital/Columbia University Medical Center — New York, New York, United States
• Changhai Hospital — Shanghai, China
• Asian Institute of Gastroenterology — Hyderabad, India

Full record on ClinicalTrials.gov

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