title: A Multicenter Feasibility Study of EBUS-TBNA for Potentially Operable Non-Small Cell Lung Cancer: The JMTO LC07-02 Study (UMIN000001280).
abstract: BACKGROUND
  Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a standard procedure for the pathological evaluation of the mediastinal nodal (N2) status of lung cancer; however, its feasibility in potentially operable patients with suspicion of minimal N2 disease remains unestablished.
  
  
  METHODS
  A prospective multicenter study was conducted to assess the feasibility of EBUS-TBNA in this setting. Patients with clinical stage IIIA-N2 non-small cell lung cancer (NSCLC) and mediastinal nodal enlargement on computed tomography (CT) were eligible; patients were ineligible when CT revealed bulky (> 3 cm in the long-axis diameter) N2 or multiple (≥ 3) station N2. If EBUS-TBNA revealed negative results, surgical staging procedures were mandatory.
  
  
  RESULTS
  Among 20 eligible patients, EBUS-TBNA provided pathological confirmation of N2 disease (true-positive) in 12 patients. Among 8 patients with negative results with EBUS-TBNA, 4 patients were pathologically diagnosed as having N2 disease with surgical staging procedures (false-negative), and 4 were finally diagnosed as having non-N2 disease with nodal dissection by thoracotomy (true-negative). As a result, the sensitivity of EBUS-TBNA for N2 evaluation (primary endpoint) was 75.0% (95% confidence interval 47.6-92.7%). No grade 3-5 adverse event were documented.
  
  
  CONCLUSIONS
  EBUS-TBNA is potentially safe and useful in the pathological evaluation of N2 status even in potentially operable NSCLC patients with suspicion of minimal N2 disease on preoperative CT.
authors.affiliation: Department of Thoracic Surgery, Hyogo College of Medicine, Nishinomiya, Japan.
authors.forename: Fumihiro
authors.initials: F
authors.lastname: Tanaka
authors.forename: Seiki
authors.initials: S
authors.lastname: Hasegawa
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Kondo
authors.forename: Ryo
authors.initials: R
authors.lastname: Miyahara
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Date
authors.forename: Shinji
authors.initials: S
authors.lastname: Atagi
authors.forename: Masaaki
authors.initials: M
authors.lastname: Kawahara
authors.forename: Takeharu
authors.initials: T
authors.lastname: Yamanaka
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Manabe
authors.forename: Hiromi
authors.initials: H
authors.lastname: Wada
mesh_terms: D001980:Bronchi / Q000473:pathology*; D002289:Carcinoma, Non-Small-Cell Lung / Q000473:pathology* / Q000601:surgery; D004210:Dissection; D061765:Endoscopic Ultrasound-Guided Fine Needle Aspiration / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007564:Japan; D008175:Lung Neoplasms / Q000473:pathology* / Q000601:surgery; D008297:Male; D009367:Neoplasm Staging; D009369:Neoplasms; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity