Endobronchial ultrasound-guided needle aspiration in non-small-cell lung cancer restaging verified by the transcervical bilateral extended mediastinal lymphadenectomy--a prospective study.

OBJECTIVES: The aim of the study was to assess the diagnostic yield of the endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in restaging of the non-small-cell lung cancer (NSCLC) patients after neo-adjuvant therapy.

METHODS: In a consecutive group of NSCLC patients with pathologically confirmed N2 disease, who underwent neo-adjuvant chemotherapy, EBUS-TBNA was performed. All patients with negative EBUS-TBNA underwent subsequently the transcervical extended bilateral mediastinal lymphadenectomy (TEMLA) as a confirmatory test.

RESULTS: A total of 61 patients underwent restaging EBUS-TBNA between 1 June 2007 and 31 December 2008. There were 85 mediastinal lymph nodes biopsied (stations: 2R - 2, 4R - 24, 2L - 1, 4L - 18 and 7 - 40). EBUS-TBNA revealed metastatic lymph node involvement in 18 of 61 patients (30%) and in 22 of 85 biopsies (26%). In 43 patients with negative or uncertain EBUS-TBNA, who underwent subsequent TEMLA, metastatic nodes were diagnosed in nine patients (15%) - in seven (12%) in stations accessible for EBUS-TBNA (stations: 2R - 1, 4R - 5, 7 - 4) and in two (3%) in station not accessible for EBUS-TBNA (station: 5 - 2). The false-negative results of biopsies were found only in small nodes (5.8+/-2.8 mm x 7.5+/-2 mm). Moreover, all positive N2 nodes diagnosed by TEMLA contained only small metastatic deposits. There were three of 61 (5%) patients with false-positive results of biopsies in stations: 4R - 1, 4L - 1, and 7 - 2. A diagnostic sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV) of the restaging EBUS-TBNA was 67% (95% confidence interval (CI) - 65-90), 86% (95% CI - 82-95), 80%, 91% (95% CI - 80-100) and 78% (95% CI - 73-93), respectively. No complications of EBUS-TBNA were observed.

CONCLUSIONS: EBUS-TBNA is an effective and safe technique for mediastinal restaging in NSCLC patients, and after the data presented in our study, in patients with negative results of EBUS-TBNA, a surgical restaging of the mediastinum might not be mandatory.