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

简要总结

主要结局

次要结局

• Ability to reach and penetrate the PCL, stratified by route of access and PCL location.(Procedure (Up to 1 hour))
• Ease of needle passage in and out of echoendoscope and quality of needle visualization inside the cyst, categorized as Excellent, Very Good, Good, Fair, and Poor(Procedure (Up to 1 hour))
• Post EUS-FNA patient management plan (clinical and/or imaging surveillance, percutaneous aspiration, surgical removal).(30 days)
• Occurrence, severity and relatedness of adverse events to the needle and procedure.(30 days)
• Extent of cyst aspiration as measured by reduction of maximal cyst diameter before and after FNA (converted to volume by standard geometric formulation).(Procedure (Up to 1 hour))
• Successful echoendoscopic fine needle aspiration of PCL, defined as complete cyst aspiration or collection of aspirate adequate to perform two standard assays: cytology and carcinoembryonic antigen (CEA)(At procedure)
• Number of EUS-FNA needles and EUS-FNA needle passes used.(Procedure (Up to 1 hour))
• Time needed for aspiration for each pass and time from first needle pass in to last needle pass out.(Procedure (Up to 1 hour))
• Accuracy of two EUS-FNA-based standard assays (cytology and CEA) as a diagnostic measure of disease state categorized as one of the following: serous cyst, mucinous cyst, intra papillary mucinous neoplasm (IPMN), or pseudocyst.(30 days)
• Impact of EUS-FNA based assays on diagnosis to determine type of cyst(Procedure - 30 days after procedure)
• Rate of cross-over to salvage arm(Procedure (Immediate))