Trial of Rapid On-Site Evaluation of Transbronchial Needle Aspirate (TBNA)
Purpose: Previous studies suggested an increased diagnostic yield for bronchoscopic (FB) transbronchial needle aspirate (TBNA) specimens from mediastinal lymph nodes when using rapid on-site evaluation by cytopathology (ROSE) but were limited by lack of randomization. The investigators performed the first randomized-prospective trial comparing ROSE(R) to no on-site cytopathology assessment (NR).
Methods: All patients referred were eligible. 78 patients were randomized to R or NR groups. For R procedures, further specimens were deferred until results were available from the on-site cytopathologist. Diagnoses made by all procedures were recorded. The primary end-points were specimen adequacy and diagnostic yield.
|Study Design:||Primary Purpose: Diagnostic|
|Official Title:||A Randomized Prospective Trial of Rapid On-Site Evaluation of Transbronchial Needle Aspirate Specimens|
- diagnostic yield [ Designated as safety issue: No ]
|Study Start Date:||November 2004|
|Study Completion Date:||December 2007|
|Primary Completion Date:||November 2007 (Final data collection date for primary outcome measure)|
|Experimental: ROSE for TBNA||
rapid on-site evaluation by cytopathology
No Intervention: NR
no on-site cytopathology assessment (NR)