EUS-guided FNA of solid pancreatic masses: a prospective, randomized trial comparing 22-gauge and 25-gauge needles

Background: There is a lack of prospective, randomized studies comparing the diagnostic yield and complication rates of 22-gauge and 25-gauge needles during EUS-FNA of solid pancreatic masses. Objectives: Our primary aim was to compare the diagnostic yield of 22-gauge and 25-guage needles. Secondary aims included determining the number of needle passes performed, ease of needle passage, and complications. Design: Prospective, randomized study. Setting: Tertiary referral centers at Yale University School of Medicine, New Haven, Connecticut, and Virginia Piper Cancer Institute, Minneapolis, Minnesota. Patients: Patients with a suspected solid pancreatic mass from February 2007 to June 2008 were enrolled. Interventions: Patients were randomized to EUS-FNA with a 22-guage or 25-gauge needle. Main Outcome Measurements: A diagnostic result Was defined as cytology findings positive for malignant cells Results: A total of 131 patients were enrolled: EUS-FNA was performed with a 22-gauge needle in 64 patients and with a 25-guage needle in 67 patients. Cytology was diagnostic in 120 (91.6%) of 131 patients overall: 56 (87.5%) of 64 with 22-gauge needles and 64 (95.5%) of 67 with 25-guage needles (no statistically significant difference was found between the 2 groups; P = .18). A similar number of passes was performed in both arms (means vertical bar SD vertical bar 2.6 vertical bar 1.2 vertical bar each; P = .96). There were no complications in either group. Limitation: A larger number of patients is needed to determine small difference in diagnostic yield. Conclusions: This is the first prospective, randomized trial comparing 22-gauge and 25-gauge neeedles in EUS-FNA of solid pancreatic masses. We achieved equally high diagnostic yields by using a similar number of passes, showing that 25-gauge needles are an effective alternative to 22-gauge needles. (Gastrointest Endosc 2009;70:1093-7.)