title: Mediastinoscopy vs endosonography for mediastinal nodal staging of lung cancer: a randomized trial.
abstract: BACKGROUND
  Mediastinal nodal staging is recommended for patients with resectable non-small cell lung cancer (NSCLC). Surgical staging has limitations, which results in the performance of unnecessary thoracotomies. Current guidelines acknowledge minimally invasive endosonography followed by surgical staging (if no nodal metastases are found by endosonography) as an alternative to immediate surgical staging.
  
  
  OBJECTIVE
  To compare the 2 recommended lung cancer staging strategies.
  
  
  METHODS
  Randomized controlled multicenter trial (Ghent, Leiden, Leuven, Papworth) conducted between February 2007 and April 2009 in 241 patients with resectable (suspected) NSCLC in whom mediastinal staging was indicated based on computed or positron emission tomography.
  
  
  METHODS
  Either surgical staging or endosonography (combined transesophageal and endobronchial ultrasound [EUS-FNA and EBUS-TBNA]) followed by surgical staging in case no nodal metastases were found at endosonography. Thoracotomy with lymph node dissection was performed when there was no evidence of mediastinal tumor spread.
  
  
  METHODS
  The primary outcome was sensitivity for mediastinal nodal (N2/N3) metastases. The reference standard was surgical pathological staging. Secondary outcomes were rates of unnecessary thoracotomy and complications.
  
  
  RESULTS
  Two hundred forty-one patients were randomized, 118 to surgical staging and 123 to endosonography, of whom 65 also underwent surgical staging. Nodal metastases were found in 41 patients (35%; 95% confidence interval [CI], 27%-44%) by surgical staging vs 56 patients (46%; 95% CI, 37%-54%) by endosonography (P = .11) and in 62 patients (50%; 95% CI, 42%-59%) by endosonography followed by surgical staging (P = .02). This corresponded to sensitivities of 79% (41/52; 95% CI, 66%-88%) vs 85% (56/66; 95% CI, 74%-92%) (P = .47) and 94% (62/66; 95% CI, 85%-98%) (P = .02). Thoracotomy was unnecessary in 21 patients (18%; 95% CI, 12%-26%) in the mediastinoscopy group vs 9 (7%; 95% CI, 4%-13%) in the endosonography group (P = .02). The complication rate was similar in both groups.
  
  
  CONCLUSIONS
  Among patients with (suspected) NSCLC, a staging strategy combining endosonography and surgical staging compared with surgical staging alone resulted in greater sensitivity for mediastinal nodal metastases and fewer unnecessary thoracotomies.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00432640.
authors.affiliation: Department of Pulmonology, C3-P, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands. j.t.annema@lumc.nl
authors.forename: Jouke T
authors.initials: JT
authors.lastname: Annema
authors.forename: Jan P
authors.initials: JP
authors.lastname: van Meerbeeck
authors.forename: Robert C
authors.initials: RC
authors.lastname: Rintoul
authors.forename: Christophe
authors.initials: C
authors.lastname: Dooms
authors.forename: Ellen
authors.initials: E
authors.lastname: Deschepper
authors.forename: Olaf M
authors.initials: OM
authors.lastname: Dekkers
authors.forename: Paul
authors.initials: P
authors.lastname: De Leyn
authors.forename: Jerry
authors.initials: J
authors.lastname: Braun
authors.forename: Nicholas R
authors.initials: NR
authors.lastname: Carroll
authors.forename: Marleen
authors.initials: M
authors.lastname: Praet
authors.forename: Frederick
authors.initials: F
authors.lastname: de Ryck
authors.forename: Johan
authors.initials: J
authors.lastname: Vansteenkiste
authors.forename: Frank
authors.initials: F
authors.lastname: Vermassen
authors.forename: Michel I
authors.initials: MI
authors.lastname: Versteegh
authors.forename: Maud
authors.initials: M
authors.lastname: Veseliç
authors.forename: Andrew G
authors.initials: AG
authors.lastname: Nicholson
authors.forename: Klaus F
authors.initials: KF
authors.lastname: Rabe
authors.forename: Kurt G
authors.initials: KG
authors.lastname: Tournoy
mesh_terms: D000368:Aged; D002289:Carcinoma, Non-Small-Cell Lung / Q000473:pathology* / Q000601:surgery; D019160:Endosonography; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000473:pathology* / Q000601:surgery; D008197:Lymph Node Excision; D008207:Lymphatic Metastasis / Q000000981:diagnostic imaging*; D008297:Male; D008481:Mediastinoscopy; D008875:Middle Aged; D009367:Neoplasm Staging / Q000379:methods*; D011183:Postoperative Complications; D012680:Sensitivity and Specificity; D013908:Thoracotomy