Randomized non-inferiority trial comparing diagnostic yield of cytopathologist-guided versus seven passes for endoscopic ultrasound-guided fine-needle aspiration of pancreatic masses

Background and Aim: To improve diagnostic yield of endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) in solid pancreatic lesions, on-site cytology review has been recommended. Because this is not widely available throughout the world, the aim of the present study was to compare the diagnostic yield of EUS-FNA carried out with rapid on-site evaluation (ROSE) versus seven FNA passes without ROSE in pancreatic masses. Methods: In this multicenter randomized non-inferiority trial, patients were randomized to ROSE versus seven passes into a solid pancreatic mass. On the basis of the absolute difference in diagnostic yield with seven passes versus cytopathologist guidance, the non-inferioritymargin for the difference in diagnostic yield was defined as -15%. Definite diagnosis was defined to include positivity for malignancy, presence of neoplastic cells, and negativity for malignancy. Results: Total of 142 patients were randomized with 73 in the cytopathologist arm and 69 in the seven-passes arm. Diagnostic yield for definite diagnosis was 78.3% with seven passes and 78.1% with cytopathology guidance. With an absolute difference 0.2%, 95% CI -14.4 to 14.6, carrying out seven passes was non-inferior to cytopathologist-guided EUS-FNA. There was no significant difference in complications or time to carry out FNA. A median of five passes were done with ROSE. Median cost with onsite cytopathology was significantly higher than carrying out seven passes ($1058 [958, 1445] vs $375 [275, 460], P < 0.001). Conclusions: Diagnostic yield for carrying out seven passes during EUS-FNA into solid pancreaticmasses is non-inferior with lower charge compared to cytopathologist guidance.