title: Lung cancer diagnosis and staging with endobronchial ultrasound-guided transbronchial needle aspiration compared with conventional approaches: an open-label, pragmatic, randomised controlled trial.
abstract: BACKGROUND
  The diagnosis and staging of lung cancer is an important process that identifies treatment options and guides disease prognosis. We aimed to assess endobronchial ultrasound-guided transbronchial needle aspiration as an initial investigation technique for patients with suspected lung cancer.
  
  
  METHODS
  In this open-label, multicentre, pragmatic, randomised controlled trial, we recruited patients who had undergone a CT scan and had suspected stage I to IIIA lung cancer, from six UK centres and randomly assigned them to either endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) or conventional diagnosis and staging (CDS), for further investigation and staging. If a target node could not be accessed by EBUS-TBNA, then endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) was allowed as an alternative procedure. Randomisation was stratified according to the presence of mediastinal lymph nodes measuring 1 cm or more in the short axis and by recruiting centre. We used a telephone randomisation method with permuted blocks of four generated by a computer. Because of the nature of the intervention, masking of participants and consenting investigators was not possible. The primary endpoint was the time-to-treatment decision after completion of the diagnostic and staging investigations and analysis was by intention-to-diagnose. This trial is registered with ClinicalTrials.gov, number NCT00652769.
  
  
  RESULTS
  Between June 10, 2008, and July 4, 2011, we randomly allocated 133 patients to treatment: 66 to EBUS-TBNA and 67 to CDS (one later withdrew consent). Two patients from the EBUS-TBNA group underwent EUS-FNA. The median time to treatment decision was shorter with EBUS-TBNA (14 days; 95% CI 14-15) than with CDS (29 days; 23-35) resulting in a hazard ratio of 1·98, (1·39-2·82, p<0·0001). One patient in each group had a pneumothorax from a CT-guided biopsy sample; the patient from the CDS group needed intercostal drainage and was admitted to hospital.
  
  
  CONCLUSIONS
  Transbronchial needle aspiration guided by endobronchial ultrasound should be considered as the initial investigation for patients with suspected lung cancer, because it reduces the time to treatment decision compared with conventional diagnosis and staging techniques.
  
  
  BACKGROUND
  UK Medical Research Council.
authors: Department of Thoracic Medicine, University College London Hospital, London, UK; Lungs for Living Research Centre, UCL Respiratory, University College London, London, UK; Medical Research Council Clinical Trials Unit, London, UK.
authors: Neal
authors: N
authors: Navani
authors: Medical Research Council Clinical Trials Unit, London, UK.
authors: Matthew
authors: M
authors: Nankivell
authors: Department of Cardiothoracic Surgery, The Heart Hospital, London, UK.
authors: David R
authors: DR
authors: Lawrence
authors: Department of Respiratory Medicine, Whittington Hospital, London, UK.
authors: Sara
authors: S
authors: Lock
authors: Department of Respiratory Medicine, North Middlesex University Hospital, London, UK.
authors: Himender
authors: H
authors: Makker
authors: Department of Respiratory Medicine, Nottingham University Hospital, Nottingham, UK.
authors: David R
authors: DR
authors: Baldwin
authors: Medical Research Council Clinical Trials Unit, London, UK.
authors: Richard J
authors: RJ
authors: Stephens
authors: Medical Research Council Clinical Trials Unit, London, UK.
authors: Mahesh K
authors: MK
authors: Parmar
authors: Department of Thoracic Medicine, University College London Hospital, London, UK; Department of Respiratory Medicine, Royal Brompton Hospital, London, UK.
authors: Stephen G
authors: SG
authors: Spiro
authors: Department of Applied Health Research, University College London, London, UK.
authors: Stephen
authors: S
authors: Morris
authors: Department of Thoracic Medicine, University College London Hospital, London, UK; Lungs for Living Research Centre, UCL Respiratory, University College London, London, UK. Electronic address: s.janes@ucl.ac.uk.
authors: Sam M
authors: SM
authors: Janes
mesh_terms: D000368:Aged; D001706:Biopsy / Q000379:methods; D001999:Bronchoscopy / Q000379:methods*; D002289:Carcinoma, Non-Small-Cell Lung / Q000175:diagnosis / Q000473:pathology*; D000066491:Clinical Decision-Making; D061765:Endoscopic Ultrasound-Guided Fine Needle Aspiration / Q000379:methods*; D005260:Female; D006801:Humans; D008168:Lung / Q000000981:diagnostic imaging / Q000473:pathology*; D008175:Lung Neoplasms / Q000175:diagnosis / Q000473:pathology*; D008198:Lymph Nodes / Q000473:pathology*; D008297:Male; D008481:Mediastinoscopy; D008875:Middle Aged; D064847:Multimodal Imaging; D009367:Neoplasm Staging; D049268:Positron-Emission Tomography; D016016:Proportional Hazards Models; D013997:Time Factors; D014057:Tomography, X-Ray Computed