title: Endoscopic ultrasound guided biopsy performed routinely in lung cancer staging spares futile thoracotomies: preliminary results from a randomised clinical trial.
abstract: BACKGROUND
  Up to 45% of operations with curative intent for non-small-cell lung cancer (NSCLC) can be regarded as futile, apparently because the stage of the disease is more advanced than expected preoperatively. During the past decade several studies have evaluated the usefulness of endoscopic ultrasound guided fine needle aspiration biopsy (EUS-FNA) in lung cancer staging with promising results. However, no randomised trials have been performed, in which a staging strategy with EUS-FNA performed in all patients is compared with a conventional workup.
  
  
  METHODS
  Before surgery (i.e. mediastinoscopy and subsequent thoracotomy) 104 patients from one hospital were randomly assigned to either a conventional workup (CWU), including EUS-FNA only for selected patients, or a strategy where all patients were offered EUS-FNA (routine EUS-FNA) in addition to CWU. Patients were followed up for a median period of 1.3 years (range 0.2-2.4 years). Thoracotomy was regarded as futile if the patient had an explorative thoracotomy without tumour resection or if a resected patient had recurrent disease or died from lung cancer during follow-up. Analysis was by intention to treat.
  
  
  RESULTS
  Fifty-three patients were randomly assigned to routine EUS-FNA and 51 patients to CWU. EUS-FNA was performed in 50 patients (94%) in the routine EUS-FNA group and in 14 patients (27%) in the CWU group. In the routine EUS-FNA group five patients (9%) had a futile thoracotomy, compared with 13 (25%) in the CWU group, p = 0.03.
  
  
  CONCLUSIONS
  Addition of routine-EUS-FNA to standard workup in routine clinical practice improved selection of surgically curable patients with NSCLC.
authors.affiliation: Department of Surgical Gasteroenterology, Gentofte University Hospital, Copenhagen, Denmark. ssl@dadlnet.dk
authors.forename: Soeren S
authors.initials: SS
authors.lastname: Larsen
authors.forename: Peter
authors.initials: P
authors.lastname: Vilmann
authors.forename: Mark
authors.initials: M
authors.lastname: Krasnik
authors.forename: Asger
authors.initials: A
authors.lastname: Dirksen
authors.forename: Paul
authors.initials: P
authors.lastname: Clementsen
authors.forename: Niels
authors.initials: N
authors.lastname: Maltbaek
authors.forename: Ulrik
authors.initials: U
authors.lastname: Lassen
authors.forename: Birgit G
authors.initials: BG
authors.lastname: Skov
authors.forename: Grete Krag
authors.initials: GK
authors.lastname: Jacobsen
mesh_terms: D000368:Aged; D001706:Biopsy / Q000379:methods*; D044963:Biopsy, Fine-Needle / Q000379:methods*; D002289:Carcinoma, Non-Small-Cell Lung / Q000175:diagnosis* / Q000000981:diagnostic imaging*; D002986:Clinical Trials as Topic; D004724:Endoscopy / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000175:diagnosis* / Q000000981:diagnostic imaging*; D008297:Male; D008481:Mediastinoscopy / Q000379:methods*; D008875:Middle Aged; D009367:Neoplasm Staging / Q000379:methods*; D011300:Preoperative Care; D011897:Random Allocation; D013908:Thoracotomy / Q000706:statistics & numerical data; D013997:Time Factors; D016896:Treatment Outcome; D014465:Ultrasonics; D014463:Ultrasonography