Background: Although rapid on-site cytologic evaluation (ROSE) is widely used during endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), its role remains unclear. Objectives: The purpose of the present study was to evaluate the efficacy of ROSE during EBUS-TBNA in the diagnosis of lung cancer. Methods: One hundred and twenty patients highly suspected of having lung cancer who had hilar/mediastinal lymphadenopathy or a tumor adjacent to the central airway were enrolled in this study and randomized to undergo EBUS-TBNA with or without ROSE. Results: Twelve patients with visible endobronchial lesions were excluded in the analysis. Thus, a total of 108 patients (55 in the ROSE group, 53 in the non-ROSE group) were analyzed. Additional procedures including EBUS-TBNA for lesions other than the main target lesion and/or transbronchial biopsy in the same setting were performed in 11% of patients in the ROSE group and 57% in the non-ROSE group (p < 0.001). Mean puncture number was significantly lower in the ROSE group (2.2 vs. 3.1 punctures, p < 0.001), and mean bronchoscopy time was similar between both groups (22.3 vs. 22.1 min, p = 0.95). The sensitivity and accuracy for diagnosing lung cancer were 88 and 89% in the ROSE group, and 86 and 89% in the non-ROSE group, respectively. No complications were associated with the procedures. Conclusions: ROSE during EBUS-TBNA is associated with a significantly lower need for additional bronchoscopic procedures and puncture number.
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