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Endobronchial Ultrasound- Transbronchial Needle Aspiration (EBUS-TBNA) Versus Mediastinoscopy for Mediastinal Lymph Node Staging of Non-small Cell Lung Cancer (NSCLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01079520
Recruitment Status : Completed
First Posted : March 3, 2010
Last Update Posted : November 1, 2012
Information provided by (Responsible Party):
Sang-Won Um, Samsung Medical Center

Brief Summary:
Accurate staging of the mediastinum is essential to evaluate prognosis in non-small cell lung cancer and to devise an appropriate treatment plan. Mediastinal staging by surgical techniques (mainly cervical mediastinoscopy) is considered to be the gold standard, although surgical staging is invasive, requires general anesthesia, and is subject to potential serious complications. Endobronchial ultrasound (EBUS)-transbronchial needle aspiration (TBNA) is a new modality for the evaluation of mediastinal and hilar lymph node metastasis from lung cancer. Compared to other diagnostic methods, EBUS-TBNA is a real-time procedure that enables multiple biopsies with high-quality histologic cores under local anesthesia. However, there have been few data on the head-to-head comparisons of mediastinoscopy and EBUS-TBNA. The aim of this prospective study is to determine the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of EBUS-TBNA and mediastinoscopy in identifying N2 and N3 lymph node for patients with non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small Cell Lung Procedure: Endobronchial ultrasound (EBUS) Procedure: Mediastinoscopy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Prospective Trial of Endobronchial Ultrasound- Transbronchial Needle Aspiration Compared to Mediastinoscopy for Mediastinal Lymph Node Staging of Non-small Cell Lung Cancer
Study Start Date : March 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Intervention Details:
  • Procedure: Endobronchial ultrasound (EBUS)
    Minimally invasive technique to stage lung cancers
  • Procedure: Mediastinoscopy
    Traditional surgical method to stage lung cancers

Primary Outcome Measures :
  1. The primary outcome measure of the study is to compare the sensitivity of EBUS-TBNA vs. mediastinoscopy. [ Time Frame: 1 month interval ]

Secondary Outcome Measures :
  1. The secondary outcome measures of the study are to compare the specificity, negative predictive value, positive predictive value, and accuracy of EBUS-TBNA vs. mediastinoscopy. [ Time Frame: 1 month interval ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histology-proven non-small cell lung cancer
  • N2 or N3 lymph node invasion is suspected based on chest CT or PET/CT scans (at least one of three criteria) : 1) enlarged (1cm or more in short axis diameter) mediastinal lymph node(s), 2) FDG uptake in the mediastinal lymph node(s), or 3) FDG uptake in N1 node(s)
  • The patient is otherwise considered a candidate for a surgical treatment with the intention to cure

Exclusion Criteria:

  • Distant metastasis
  • Inoperable T4 disease
  • Confirmed supraclavicular lymph node metastasis
  • Former therapy (chemotherapy or radiotherapy or surgery) for lung cancer
  • Contraindications for bronchoscopy
  • Uncorrected coagulopathy
  • Concurrent other malignancies
  • Suspicious mediastinal lymph node metastasis which are not accessible by EBUS-TBNA or mediastinoscopy (i.e. paraaortic, aortopulmonary window, or paraesophageal lymph nodes)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01079520

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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
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Principal Investigator: Sang-Won Um, MD Samsung Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sang-Won Um, Assistant Professor, Samsung Medical Center Identifier: NCT01079520    
Other Study ID Numbers: 2009-08-053
CRS110-19-1 ( Other Grant/Funding Number: Samsung Medical Center Clinical Research Development Program )
First Posted: March 3, 2010    Key Record Dates
Last Update Posted: November 1, 2012
Last Verified: October 2012
Keywords provided by Sang-Won Um, Samsung Medical Center:
Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms