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Mediastinoscopy vs endosonography for mediastinal nodal staging of lung cancer: a randomized trial

Jouke T Annema, Jan Van Meerbeeck UGent, Robert C Rintoul, Christophe Dooms, Ellen Deschepper UGent, Olaf M Dekkers, Paul De Leyn, Jerry Braun, Nicholas R Carroll and Marleen Praet UGent, et al. (2010) JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION. 304(20). p.2245-2252
abstract
Context Mediastinal nodal staging is recommended for patients with resectable non-small cell lung cancer (NSCLC). Surgical staging has limitations, which results in the performance of unnecessary thoracotomies. Current guidelines acknowledge minimally invasive endosonography followed by surgical staging (if no nodal metastases are found by endosonography) as an alternative to immediate surgical staging. Objective To compare the 2 recommended lung cancer staging strategies. Design, Setting, and Patients Randomized controlled multicenter trial (Ghent, Leiden, Leuven, Papworth) conducted between February 2007 and April 2009 in 241 patients with resectable (suspected) NSCLC in whom mediastinal staging was indicated based on computed or positron emission tomography. Intervention Either surgical staging or endosonography (combined transesophageal and endobronchial ultrasound [EUS-FNA and EBUS-TBNA]) followed by surgical staging in case no nodal metastases were found at endosonography. Thoracotomy with lymph node dissection was performed when there was no evidence of mediastinal tumor spread. Main Outcome Measures The primary outcome was sensitivity for mediastinal nodal (N2/N3) metastases. The reference standard was surgical pathological staging. Secondary outcomes were rates of unnecessary thoracotomy and complications. Results Two hundred forty-one patients were randomized, 118 to surgical staging and 123 to endosonography, of whom 65 also underwent surgical staging. Nodal metastases were found in 41 patients (35%; 95% confidence interval [CI], 27%-44%) by surgical staging vs 56 patients (46%; 95% CI, 37%-54%) by endosonography (P=.11) and in 62 patients (50%; 95% CI, 42%-59%) by endosonography followed by surgical staging (P=.02). This corresponded to sensitivities of 79% (41/52; 95% CI, 66%-88%) vs 85% (56/66; 95% CI, 74%-92%) (P=.47) and 94% (62/66; 95% CI, 85%-98%) (P=.02). Thoracotomy was unnecessary in 21 patients (18%; 95% CI, 12%-26%) in the mediastinoscopy group vs 9 (7%; 95% CI, 4%-13%) in the endosonography group (P=.02). The complication rate was similar in both groups. Conclusions Among patients with (suspected) NSCLC, a staging strategy combining endosonography and surgical staging compared with surgical staging alone resulted in greater sensitivity for mediastinal nodal metastases and fewer unnecessary thoracotomies. Trial Registration clinicaltrials.gov Identifier: NCT00432640
Please use this url to cite or link to this publication:
author
organization
year
type
journalArticle (original)
publication status
published
subject
keyword
DEFINITION, CLASSIFICATION, EBUS-TBNA, DIAGNOSIS, ESTS GUIDELINES, ENDOBRONCHIAL ULTRASOUND, ENDOSCOPIC ULTRASOUND, GUIDELINES 2ND EDITION, FINE-NEEDLE-ASPIRATION, SURGERY
journal title
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
JAMA-J. Am. Med. Assoc.
volume
304
issue
20
pages
2245 - 2252
Web of Science type
Article
Web of Science id
000284548400023
JCR category
MEDICINE, GENERAL & INTERNAL
JCR impact factor
30.011 (2010)
JCR rank
3/151 (2010)
JCR quartile
1 (2010)
ISSN
0098-7484
DOI
10.1001/jama.2010.1705
language
English
UGent publication?
yes
classification
A1
copyright statement
I have transferred the copyright for this publication to the publisher
id
1087565
handle
http://hdl.handle.net/1854/LU-1087565
date created
2010-12-15 10:24:12
date last changed
2015-06-17 09:19:22
@article{1087565,
  abstract     = {Context Mediastinal nodal staging is recommended for patients with resectable non-small cell lung cancer (NSCLC). Surgical staging has limitations, which results in the performance of unnecessary thoracotomies. Current guidelines acknowledge minimally invasive endosonography followed by surgical staging (if no nodal metastases are found by endosonography) as an alternative to immediate surgical staging. 
Objective To compare the 2 recommended lung cancer staging strategies.
Design, Setting, and Patients Randomized controlled multicenter trial (Ghent, Leiden, Leuven, Papworth) conducted between February 2007 and April 2009 in 241 patients with resectable (suspected) NSCLC in whom mediastinal staging was indicated based on computed or positron emission tomography.
Intervention Either surgical staging or endosonography (combined transesophageal and endobronchial ultrasound [EUS-FNA and EBUS-TBNA]) followed by surgical staging in case no nodal metastases were found at endosonography. Thoracotomy with lymph node dissection was performed when there was no evidence of mediastinal tumor spread.
Main Outcome Measures The primary outcome was sensitivity for mediastinal nodal (N2/N3) metastases. The reference standard was surgical pathological staging. Secondary outcomes were rates of unnecessary thoracotomy and complications.
Results Two hundred forty-one patients were randomized, 118 to surgical staging and 123 to endosonography, of whom 65 also underwent surgical staging. Nodal metastases were found in 41 patients (35\%; 95\% confidence interval [CI], 27\%-44\%) by surgical staging vs 56 patients (46\%; 95\% CI, 37\%-54\%) by endosonography (P=.11) and in 62 patients (50\%; 95\% CI, 42\%-59\%) by endosonography followed by surgical staging (P=.02). This corresponded to sensitivities of 79\% (41/52; 95\% CI, 66\%-88\%) vs 85\% (56/66; 95\% CI, 74\%-92\%) (P=.47) and 94\% (62/66; 95\% CI, 85\%-98\%) (P=.02). Thoracotomy was unnecessary in 21 patients (18\%; 95\% CI, 12\%-26\%) in the mediastinoscopy group vs 9 (7\%; 95\% CI, 4\%-13\%) in the endosonography group (P=.02). The complication rate was similar in both groups.
Conclusions Among patients with (suspected) NSCLC, a staging strategy combining endosonography and surgical staging compared with surgical staging alone resulted in greater sensitivity for mediastinal nodal metastases and fewer unnecessary thoracotomies. Trial Registration clinicaltrials.gov Identifier: NCT00432640},
  author       = {Annema, Jouke T and Van Meerbeeck, Jan and Rintoul, Robert C and Dooms, Christophe and Deschepper, Ellen and Dekkers, Olaf M and De Leyn, Paul and Braun, Jerry and Carroll, Nicholas R and Praet, Marleen and De Ryck, Frederik and Vansteenkiste, Johan and Vermassen, Frank and Versteegh, Michel I and Veseli\c{c}, Maud and Nicholson, Andrew G and Rabe, Klaus F and Tournoy, Kurt},
  issn         = {0098-7484},
  journal      = {JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION},
  keyword      = {DEFINITION,CLASSIFICATION,EBUS-TBNA,DIAGNOSIS,ESTS GUIDELINES,ENDOBRONCHIAL ULTRASOUND,ENDOSCOPIC ULTRASOUND,GUIDELINES 2ND EDITION,FINE-NEEDLE-ASPIRATION,SURGERY},
  language     = {eng},
  number       = {20},
  pages        = {2245--2252},
  title        = {Mediastinoscopy vs endosonography for mediastinal nodal staging of lung cancer: a randomized trial},
  url          = {http://dx.doi.org/10.1001/jama.2010.1705},
  volume       = {304},
  year         = {2010},
}

Chicago
Annema, Jouke T, Jan Van Meerbeeck, Robert C Rintoul, Christophe Dooms, Ellen Deschepper, Olaf M Dekkers, Paul De Leyn, et al. 2010. “Mediastinoscopy Vs Endosonography for Mediastinal Nodal Staging of Lung Cancer: a Randomized Trial.” Jama-journal of the American Medical Association 304 (20): 2245–2252.
APA
Annema, J. T., Van Meerbeeck, J., Rintoul, R. C., Dooms, C., Deschepper, E., Dekkers, O. M., De Leyn, P., et al. (2010). Mediastinoscopy vs endosonography for mediastinal nodal staging of lung cancer: a randomized trial. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 304(20), 2245–2252.
Vancouver
1.
Annema JT, Van Meerbeeck J, Rintoul RC, Dooms C, Deschepper E, Dekkers OM, et al. Mediastinoscopy vs endosonography for mediastinal nodal staging of lung cancer: a randomized trial. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION. 2010;304(20):2245–52.
MLA
Annema, Jouke T, Jan Van Meerbeeck, Robert C Rintoul, et al. “Mediastinoscopy Vs Endosonography for Mediastinal Nodal Staging of Lung Cancer: a Randomized Trial.” JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION 304.20 (2010): 2245–2252. Print.