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Lung cancer diagnosis and staging with endobronchial ultrasound-guided transbronchial needle aspiration compared with conventional approaches : an open-label , pragmatic , randomised controlled trial . 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 . FINDINGS 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 . INTERPRETATION 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 . FUNDING UK Medical Research Council .
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Intervention_Physical
endobronchial ultrasound-guided transbronchial needle aspiration
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Intervention_Physical
endobronchial ultrasound-guided transbronchial needle aspiration
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Intervention_Physical
endobronchial ultrasound-guided transbronchial needle aspiration
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Intervention_Physical
conventional diagnosis and staging
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Intervention_Physical
endoscopic ultrasound-guided fine needle aspiration
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Outcome_Mental
time-to-treatment decision
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Outcome_Mental
median time to treatment decision
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Outcome_Adverse-effects
pneumothorax
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Participant_Condition
Lung cancer diagnosis
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Participant_Condition
patients with suspected lung cancer .
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Participant_Condition
lung cancer
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Participant_Sample-size
133 patients
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Participant_Sample-size
66
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Participant_Sample-size
67
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Participant_Condition
for patients with suspected lung cancer