Lung cancer diagnosis and staging with endobronchial ultrasound-guided transbronchial needle aspiration compared with conventional approaches: an open-label, pragmatic, randomised controlled trial.

NMUH Staff Publications

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<h4 style="font-size: 13px; margin: 0px 0.25em 0px 0px; text-transform: uppercase; float: left; font-family: arial, helvetica, clean, sans-serif; line-height: 17.9998016357422px;"><span style="font-size: 8pt;"><span style="font-family: Arial;">BACKGROUND:</span></span></h4><p style="margin: 0px 0px 0.5em; font-family: arial, helvetica, clean, sans-serif; font-size: 13px; line-height: 17.9998016357422px;"><span style="font-size: 8pt;"><span style="font-family: Arial;">The <span class="highlight">diagnosis</span> and <span class="highlight">staging</span> of <span class="highlight">lung</span> <span class="highlight">cancer</span> is an important process that identifies treatment options and guides disease prognosis. We aimed to assess <span class="highlight">endobronchial</span> <span class="highlight">ultrasound-guided</span> <span class="highlight">transbronchial</span> <span class="highlight">needle</span> <span class="highlight">aspiration</span> as an initial investigation technique for patients with suspected<span class="highlight">lung</span> <span class="highlight">cancer</span>.</span></span></p><h4 style="font-size: 13px; margin: 0px 0.25em 0px 0px; text-transform: uppercase; float: left; font-family: arial, helvetica, clean, sans-serif; line-height: 17.9998016357422px;"><span style="font-size: 8pt;"><span style="font-family: Arial;">METHODS:</span></span></h4><p style="margin: 0px 0px 0.5em; font-family: arial, helvetica, clean, sans-serif; font-size: 13px; line-height: 17.9998016357422px;"><span style="font-size: 8pt;"><span style="font-family: Arial;">In this <span class="highlight">open-label</span>, multicentre, <span class="highlight">pragmatic</span>, <span class="highlight">randomised</span> <span class="highlight">controlled</span> <span class="highlight">trial</span>, we recruited patients who had undergone a CT scan and had suspected stage I to IIIA <span class="highlight">lung</span> <span class="highlight">cancer</span>, from six UK centres and randomly assigned them to either <span class="highlight">endobronchial</span> <span class="highlight">ultrasound-guided</span> <span class="highlight">transbronchial</span><span class="highlight">needle</span> <span class="highlight">aspiration</span> (EBUS-TBNA) or <span class="highlight">conventional</span> <span class="highlight">diagnosis</span> and <span class="highlight">staging</span> (CDS), for further investigation and <span class="highlight">staging</span>. If a target node could not be accessed by EBUS-TBNA, then endoscopic <span class="highlight">ultrasound-guided</span> fine <span class="highlight">needle</span> <span class="highlight">aspiration</span> (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 <span class="highlight">staging</span> investigations and analysis was by intention-to-diagnose. This <span class="highlight">trial</span> is registered with ClinicalTrials.gov, number<a href="http://clinicaltrials.gov/show/NCT00652769" title="See in ClincalTrials.gov" style="border-bottom-width: 0px;">NCT00652769</a>.</span></span></p><h4 style="font-size: 13px; margin: 0px 0.25em 0px 0px; text-transform: uppercase; float: left; font-family: arial, helvetica, clean, sans-serif; line-height: 17.9998016357422px;"><span style="font-size: 8pt;"><span style="font-family: Arial;">FINDINGS:</span></span></h4><p style="margin: 0px 0px 0.5em; font-family: arial, helvetica, clean, sans-serif; font-size: 13px; line-height: 17.9998016357422px;"><span style="font-size: 8pt;"><span style="font-family: Arial;">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.</span></span></p><h4 style="font-size: 13px; margin: 0px 0.25em 0px 0px; text-transform: uppercase; float: left; font-family: arial, helvetica, clean, sans-serif; line-height: 17.9998016357422px;"><span style="font-size: 8pt;"><span style="font-family: Arial;">INTERPRETATION:</span></span></h4><p style="margin: 0px 0px 0.5em; font-family: arial, helvetica, clean, sans-serif; font-size: 13px; line-height: 17.9998016357422px;"><span style="font-family: Arial;"><span style="font-size: 8pt;"><span class="highlight">Transbronchial</span> <span class="highlight">needle</span> <span class="highlight">aspiration</span> guided by <span class="highlight">endobronchial</span> ultrasound should be considered as the initial investigation for patients with suspected <span class="highlight">lung</span> <span class="highlight">cancer</span>, because it reduces the time to treatment decision <span class="highlight">compared</span> with <span class="highlight">conventional</span> <span class="highlight">diagnosis</span> and <span class="highlight">staging</span>techniques.</span></span></p>