Randomized Trial Comparing 19 and 25G Needles for Fine Needle Aspiration (FNA) of Solid Pancreatic Mass Lesions Greater Than 35mm
Endoscopic Ultrasound-guided fine needle aspiration (EUS-FNA) can be performed using the 25,
22 or 19 gauge (G) needles. Randomized trials have shown that all three needles are safe and
perform equally well. However, in a retrospective study, the diagnostic sensitivity of
EUS-FNA for pancreatic masses that measured more than 35mm was less compared to smaller size
masses. This is because larger size tumors have more necrosis and it is difficult to
identify cancer cells in them to make a diagnosis. Therefore, more biopsies must be
performed in larger size tumors to establish a diagnosis. In previous studies it has been
shown that the larger 19G needles procure larger and better quality tissue. Therefore, our
hypothesis is that, when a larger 19G needle is used to FNA tumors more than 35mm, a
diagnosis can be achieved with fewer passes.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
Number of passes
The use of a 19G FNA needle reduces the number of passes required to establish a diagnosis in pancreatic tumors that are greater than 35mm in size. This translates to less sedation, faster patient recovery, better safety and time efficiency.
Up to 12 months
No
Shyam Varadarajulu, MD
Principal Investigator
Florida Hospital
United States: Institutional Review Board
405581
NCT01815606
February 2013
December 2013
Name | Location |
---|---|
Florida Hospital | Orlando, Florida 32803 |