1022 Multi-Center Randomized Trial Comparing the 19G and 25G Needles for EUS-Guided FNA of Solid Pancreatic Mass Lesions

Abstract

100 Multi-Center Randomized Trial Comparing the 19G and 25G Needles for EUS-Guided FNA of Large Solid Pancreatic Mass Lesions Muhammad Hasan, Jayapal Ramesh, Ji Young Bang, Bronte a. Holt, Shantel Hebert-Magee, Amy L. Logue, Robert Hawes, Shyam Varadarajulu* Center for Interventional Endoscopy, Florida Hospital, Orlando, FL; Medicine, University of Alabama at Birmingham, Birmingham, AL Background: Retrospective studies suggest that given the increased necrosis in large solid pancreatic mass lesions, more passes are required at EUS-FNA for establishing onsite diagnostic adequacy. The hypothesis of this study is that a larger gauge needle will procure more tissue than a smaller gauge needle and therefore will establish the diagnosis with fewer FNA passes. Aim: To compare 19 and 25G needles for EUS-FNA of large solid pancreatic mass lesions. Methods: In this multi-center trial, patients with solid pancreatic mass lesions 35mm or greater in size were randomized to undergo EUS-FNA using 19 or 25G needle. FNA maneuvers were performed using the fanning technique and without the use of suction. A pathologist blinded to randomization sequence evaluated specimens onsite for diagnostic adequacy. Main outcome measures: Compare the median number of passes needed to establish onsite diagnostic adequacy, specimen quality (bloodiness graded as mild if!33%, moderate if 34-66%, severe if O67%) and complications between 19 and 25G needles. Sample size was estimated based on detecting a difference of one pass required to establish onsite diagnostic adequacy, using standard deviation of 1 for 19G and 1.9 for 25G needle (power 80%, aZ0.05). Results: Of 80 randomized patients (19GZ40; 25GZ40) there was no significant difference in patient or disease characteristics between the cohorts (Table). Except for specimen bloodiness that was significantly greater in the 19G cohort, there was no difference in the median number of passes required to establish onsite diagnostic adequacy, final diagnosis, technical failures (none) or complications (none) between the two cohorts. Conclusion: 19G needle has no advantage over a 25G needle for establishing onsite diagnostic adequacy when performing EUS-FNA of large solid pancreatic mass lesions.