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We reviewed 111 bronchoscopy-guided transtracheal and transbronchial fine-needle aspiration (TT/TBNA) specimens from 97 patients to determine the sensitivity and specificity for diagnosing neoplasia compared to surgical biopsy and clinical follow-up and to determine the optimal number of passes. Fifty were positive for neoplasia, seven were suspicious, one was atypical, 51 were negative, and two were unsatisfactory. Of 57 positive/suspicious cases, 56 were confirmed neoplastic, with one patient lost to follow-up (specificity with follow-up: 100%). A positive diagnosis was rendered on the first pass in 29 cases (58%), second in six (12%), third in five (10%), fourth in three (6%), fifth in four (8%), and sixth, ninth, and eleventh passes in one case each (2% each). Twenty-seven negative cases had confirmed malignancies after their index FNA (sensitivity for neoplasia: 67%). We conclude that TT/TBNA is a highly specific but not always successful diagnostic technique. It appears to be limited by mechanical difficulties that prevent tumor access and cellular uptake in some masses. Little information is gained by procuring more than six samples., (Copyright 2002 Wiley-Liss, Inc.)