Lung cancer diagnosis and staging with endobronchial ultrasound-guided transbronchial needle aspiration compared with conventional approaches: an open-label, pragmatic, randomised controlled trial. (Record no. 75852)

MARC details
000 -LEADER
fixed length control field 07888cam a2200301 4500
001 - CONTROL NUMBER
control field NMDX6729
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 120401t2015 xxu||||| |||| 00| 0 eng d
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER
International Standard Serial Number 22132600
100 ## - MAIN ENTRY--PERSONAL NAME
Personal name Navani, N.
240 ## - UNIFORM TITLE
Uniform title <a href="The Lancet Respiratory Medicine">The Lancet Respiratory Medicine</a>
245 ## - TITLE STATEMENT
Title Lung cancer diagnosis and staging with endobronchial ultrasound-guided transbronchial needle aspiration compared with conventional approaches: an open-label, pragmatic, randomised controlled trial.
260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT)
Date of publication, distribution, etc. 2015
500 ## - GENERAL NOTE
General note NMUH Staff Publications
500 ## - GENERAL NOTE
General note 3
520 ## - SUMMARY, ETC.
Summary, etc. &lt;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;"&gt;&lt;span style="font-size: 8pt;"&gt;&lt;span style="font-family: Arial;"&gt;BACKGROUND:&lt;/span&gt;&lt;/span&gt;&lt;/h4&gt;&lt;p style="margin: 0px 0px 0.5em; font-family: arial, helvetica, clean, sans-serif; font-size: 13px; line-height: 17.9998016357422px;"&gt;&lt;span style="font-size: 8pt;"&gt;&lt;span style="font-family: Arial;"&gt;The&amp;nbsp;&lt;span class="highlight"&gt;diagnosis&lt;/span&gt;&amp;nbsp;and&amp;nbsp;&lt;span class="highlight"&gt;staging&lt;/span&gt;&amp;nbsp;of&amp;nbsp;&lt;span class="highlight"&gt;lung&lt;/span&gt;&amp;nbsp;&lt;span class="highlight"&gt;cancer&lt;/span&gt;&amp;nbsp;is an important process that identifies treatment options and guides disease prognosis. We aimed to assess&amp;nbsp;&lt;span class="highlight"&gt;endobronchial&lt;/span&gt;&amp;nbsp;&lt;span class="highlight"&gt;ultrasound-guided&lt;/span&gt;&amp;nbsp;&lt;span class="highlight"&gt;transbronchial&lt;/span&gt;&amp;nbsp;&lt;span class="highlight"&gt;needle&lt;/span&gt;&amp;nbsp;&lt;span class="highlight"&gt;aspiration&lt;/span&gt;&amp;nbsp;as an initial investigation technique for patients with suspected&lt;span class="highlight"&gt;lung&lt;/span&gt;&amp;nbsp;&lt;span class="highlight"&gt;cancer&lt;/span&gt;.&lt;/span&gt;&lt;/span&gt;&lt;/p&gt;&lt;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;"&gt;&lt;span style="font-size: 8pt;"&gt;&lt;span style="font-family: Arial;"&gt;METHODS:&lt;/span&gt;&lt;/span&gt;&lt;/h4&gt;&lt;p style="margin: 0px 0px 0.5em; font-family: arial, helvetica, clean, sans-serif; font-size: 13px; line-height: 17.9998016357422px;"&gt;&lt;span style="font-size: 8pt;"&gt;&lt;span style="font-family: Arial;"&gt;In this&amp;nbsp;&lt;span class="highlight"&gt;open-label&lt;/span&gt;, multicentre,&amp;nbsp;&lt;span class="highlight"&gt;pragmatic&lt;/span&gt;,&amp;nbsp;&lt;span class="highlight"&gt;randomised&lt;/span&gt;&amp;nbsp;&lt;span class="highlight"&gt;controlled&lt;/span&gt;&amp;nbsp;&lt;span class="highlight"&gt;trial&lt;/span&gt;, we recruited patients who had undergone a CT scan and had suspected stage I to IIIA&amp;nbsp;&lt;span class="highlight"&gt;lung&lt;/span&gt;&amp;nbsp;&lt;span class="highlight"&gt;cancer&lt;/span&gt;, from six UK centres and randomly assigned them to either&amp;nbsp;&lt;span class="highlight"&gt;endobronchial&lt;/span&gt;&amp;nbsp;&lt;span class="highlight"&gt;ultrasound-guided&lt;/span&gt;&amp;nbsp;&lt;span class="highlight"&gt;transbronchial&lt;/span&gt;&lt;span class="highlight"&gt;needle&lt;/span&gt;&amp;nbsp;&lt;span class="highlight"&gt;aspiration&lt;/span&gt;&amp;nbsp;(EBUS-TBNA) or&amp;nbsp;&lt;span class="highlight"&gt;conventional&lt;/span&gt;&amp;nbsp;&lt;span class="highlight"&gt;diagnosis&lt;/span&gt;&amp;nbsp;and&amp;nbsp;&lt;span class="highlight"&gt;staging&lt;/span&gt;&amp;nbsp;(CDS), for further investigation and&amp;nbsp;&lt;span class="highlight"&gt;staging&lt;/span&gt;. If a target node could not be accessed by EBUS-TBNA, then endoscopic&amp;nbsp;&lt;span class="highlight"&gt;ultrasound-guided&lt;/span&gt;&amp;nbsp;fine&amp;nbsp;&lt;span class="highlight"&gt;needle&lt;/span&gt;&amp;nbsp;&lt;span class="highlight"&gt;aspiration&lt;/span&gt;&amp;nbsp;(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&amp;nbsp;&lt;span class="highlight"&gt;staging&lt;/span&gt;&amp;nbsp;investigations and analysis was by intention-to-diagnose. This&amp;nbsp;&lt;span class="highlight"&gt;trial&lt;/span&gt;&amp;nbsp;is registered with ClinicalTrials.gov, number&lt;a href="http://clinicaltrials.gov/show/NCT00652769" title="See in ClincalTrials.gov" style="border-bottom-width: 0px;"&gt;NCT00652769&lt;/a&gt;.&lt;/span&gt;&lt;/span&gt;&lt;/p&gt;&lt;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;"&gt;&lt;span style="font-size: 8pt;"&gt;&lt;span style="font-family: Arial;"&gt;FINDINGS:&lt;/span&gt;&lt;/span&gt;&lt;/h4&gt;&lt;p style="margin: 0px 0px 0.5em; font-family: arial, helvetica, clean, sans-serif; font-size: 13px; line-height: 17.9998016357422px;"&gt;&lt;span style="font-size: 8pt;"&gt;&lt;span style="font-family: Arial;"&gt;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&amp;lt;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.&lt;/span&gt;&lt;/span&gt;&lt;/p&gt;&lt;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;"&gt;&lt;span style="font-size: 8pt;"&gt;&lt;span style="font-family: Arial;"&gt;INTERPRETATION:&lt;/span&gt;&lt;/span&gt;&lt;/h4&gt;&lt;p style="margin: 0px 0px 0.5em; font-family: arial, helvetica, clean, sans-serif; font-size: 13px; line-height: 17.9998016357422px;"&gt;&lt;span style="font-family: Arial;"&gt;&lt;span style="font-size: 8pt;"&gt;&lt;span class="highlight"&gt;Transbronchial&lt;/span&gt;&amp;nbsp;&lt;span class="highlight"&gt;needle&lt;/span&gt;&amp;nbsp;&lt;span class="highlight"&gt;aspiration&lt;/span&gt;&amp;nbsp;guided by&amp;nbsp;&lt;span class="highlight"&gt;endobronchial&lt;/span&gt;&amp;nbsp;ultrasound should be considered as the initial investigation for patients with suspected&amp;nbsp;&lt;span class="highlight"&gt;lung&lt;/span&gt;&amp;nbsp;&lt;span class="highlight"&gt;cancer&lt;/span&gt;, because it reduces the time to treatment decision&amp;nbsp;&lt;span class="highlight"&gt;compared&lt;/span&gt;&amp;nbsp;with&amp;nbsp;&lt;span class="highlight"&gt;conventional&lt;/span&gt;&amp;nbsp;&lt;span class="highlight"&gt;diagnosis&lt;/span&gt;&amp;nbsp;and&amp;nbsp;&lt;span class="highlight"&gt;staging&lt;/span&gt;techniques.&lt;/span&gt;&lt;/span&gt;&lt;/p&gt;
700 ## - ADDED ENTRY--PERSONAL NAME
Personal name Nankivell, M.
700 ## - ADDED ENTRY--PERSONAL NAME
Personal name Lawrence, D.R.
700 ## - ADDED ENTRY--PERSONAL NAME
Personal name Lock, S.
700 ## - ADDED ENTRY--PERSONAL NAME
Personal name Makker, H.K.
700 ## - ADDED ENTRY--PERSONAL NAME
Personal name Baldwin, D.R.
700 ## - ADDED ENTRY--PERSONAL NAME
Personal name Stephens, R.J.
700 ## - ADDED ENTRY--PERSONAL NAME
Personal name Parmar, M.K.
700 ## - ADDED ENTRY--PERSONAL NAME
Personal name Spiro, S.G.
700 ## - ADDED ENTRY--PERSONAL NAME
Personal name Morris, S.
700 ## - ADDED ENTRY--PERSONAL NAME
Personal name Janes, S.M.
710 ## - ADDED ENTRY--CORPORATE NAME
Corporate name or jurisdiction name as entry element Lung-BOOST trial investigators
856 ## - ELECTRONIC LOCATION AND ACCESS
Uniform Resource Identifier <a href="http://www.sciencedirect.com/science/article/pii/S2213260015000296">http://www.sciencedirect.com/science/article/pii/S2213260015000296</a>
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