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A Prospective Controlled Trial of Endobronchial Ultrasound guided Transbronchial Needle Aspiration Compared to Mediastinoscopy for Mediastinal Lymph Node Staging of Lung Cancer
K. Yasufuku1, M. Quadri1, M. dePerrot1, A. Pierre1, T. Waddell1, G. Darling1, M. Johnston1, W. Geddie2, S. Boerner2, T. Fujisawa3, S. Keshavjee1. 1Division of Thoracic Surgery, Toronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada, 2Department of Pathology, Toronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada, 3Department of Thoracic Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan,
BACKGROUND: Endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) is a minimally invasive lymph node sampling modality capable of sampling mediastinal and hilar lymph nodes under real-time ultrasound control. The purpose of the current study was to compare EBUS-TBNA to the current ‘gold standard’ for mediastinal lymph node sampling: mediastinoscopy (MS) for mediastinal lymph node staging of non-small cell lung cancer (NSCLC).
METHODS: Patients with confirmed or suspected NSCLC who require MS to determine suitability for lung cancer resection were entered into the trial. All patients underwent EBUS-TBNA followed by MS under general anesthesia. The convex probe EBUS integrated with a 7.5 MHz convex scanning probe on its tip was used for EBUS-TBNA. EBUS-TBNA was performed for all lymph nodes > 5mm in short axis using a dedicated 22-gauge needle. Rapid on-site cytology was performed to confirm the adequacy of the specimen. The surgeon performing the MS was blinded to the pathological findings of the EBUS during the procedure. If the absence of N2 or N3 disease was confirmed, the patient went on to thoracotomy for lung resection.
RESULTS: Between July 2006 to December 2006, 45 patients were enrolled in the study. 33 (32 NSCLC, 1SCLC) cases were completed. The mean age of the group was 65 years (range, 45 to 85 years). The clinical staging prior to EBUS-TBNA and MS were 12 stage IA, 9 stage IB, 9 stage IIIA, 2 stage IIIB, and 1 stage IV disease. EBUS visualized 146 lymph nodes (average 4.4/patient) out of which EBUS-TBNA were performed in 111 lymph nodes in various stations (average 3.4/patient). The mean short axis of the biopsied lymph nodes was 6.7 mm (range, 2 to 23 mm). MS sampled 133 lymph nodes (average 4.0/patient). The prevalence of N2/N3 disease was 39.4 %. Three patients diagnosed as N0 disease by EBUS-TBNA were upstaged to N2 disease by MS. On the other hand, EBUS-TBNA upstaged two patients diagnosed as N0 by MS to N2 disease. The diagnostic accuracy of EBUS-TBNA and MS for analysis of each lymph node stations were 95.6 % and 96.6 %. The sensitivity, specificity, and diagnostic accuracy for the correct lymph node staging for EBUS-TBNA and MS were 76.9 %, 100%, 90.9 %, and 84.6%, 100%, 93.9% respectively. EBUS-TBNA was uneventful and there were no complications.
CONCLUSIONS: This study exploring this new technology is ongoing. EBUS-TBNA is a safe procedure that has access to all of the lymph node stations accessible to MS, as well as N1 hilar lymph node stations. These preliminary results show that EBUS-TBNA may reduce the number of MS needed for the staging of the mediastinum in NSCLC. However, due to the possibility of micrometastases, it is not clear that EBUS-TBNA will completely replace MS for mediastinal staging.
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