A study of a Randomized Evaluation of Pancreatic Cystic Lesions Using Three EUS-FNA Needles
Phase 4
- Conditions
- Health Condition 1: null- Pancreatic Cystic Lesions
- Registration Number
- CTRI/2014/08/004845
- Lead Sponsor
- Boston Scientific
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 47
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 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Volume of aspirated cyst fluid as a function of estimated maximal volume based on pre-aspiration EUS measure of cyst diameter (s) (% aspiration of total estimated volume)Timepoint: At Procedure (Up to 1 hour)
- Secondary Outcome Measures
Name Time Method