A Randomized Prospective Trial of the Utility of Rapid On-Site Evaluation of Transbronchial Needle Aspirate Specimens

Background: Previous studies have suggested an increased diagnostic yield for flexible bronchoscopic transbronchial needle aspirate (TBNA) specimens from lymph nodes when using rapid on-site evaluation by cytopathology but were limited by a lack of randomization, suggesting that selection bias may have contributed to its higher reported yield with TBNA. Objectives: The purpose of our study was to determine the effect of rapid on-site evaluation (ROSE) on the diagnostic power of TBNA. Methods: The study is a prospective randomized controlled trial. Diagnoses made by procedures were recorded prospectively. The primary endpoint was diagnostic yield. Results: Thirty-four patients were randomized to the ROSE group and 34 patients to the no-ROSE group. Specimen adequacy was 94% in the ROSE group and 88% in the no-ROSE group (P = 0.67). The TBNA diagnostic yield was similar in both groups: ROSE, 55%; no-ROSE, 53% (P = 1.000). Neoplastic diagnoses were made in 59% and 50% of ROSE and no-ROSE patients, respectively (P = 0.63). There were no significant differences in the number of needle passes, procedure duration, or amount of sedatives used. There was a trend toward a decrease in the number of transbronchial biopsies needed in the ROSE group. Conclusions: Previous reports of increased diagnostic yield of ROSE were subject to selection bias. Routine use of ROSE in all TBNA procedures was not associated with a reduced procedure time or sedative use. ROSE may be beneficial by decreasing the need for transbronchial biopsy and the associated risk or if the probability of malignancy is likely. We recommend ROSE in selected patients over all TBNA procedures.