NCT01711294

Evaluation of PCLs Using Three EUS-FNA Needles

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Cystic Lesions

Interventions

Type	Name	Description
DEVICE	19 G Flex Needle	Fine Needle Aspiration of PCL with a 19 G Flex needle. If unsuccessful, a salvage procedure will be done with 19 G or 22 G needle.
DEVICE	22 G Needle	Fine Needle Aspiration of PCL with a 22 G needle. If unsuccessful, a salvage procedure will be done with 19 G Flex needle.
DEVICE	19 G Needle	Fine Needle Aspiration of PCL with a 19 G needle. If unsuccessful, a salvage procedure will be done with 19 G Flex needle.

Timeline

• Start date: 2013-01-08
• Primary completion: 2017-06-06
• Completion: 2019-12-18
• First posted: 2012-10-22
• Last updated: 2021-01-15
• Results posted: 2020-11-12

Locations

8 sites across 3 countries: United States, China, India