부산대학교 도서관

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-inferiority margin 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 pancreatic masses is non-inferior with lower charge compared to cytopathologist guidance. [ABSTRACT FROM AUTHOR]