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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sang-Won Um, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01079520
First received: January 20, 2010
Last updated: October 31, 2012
Last verified: October 2012
  Purpose

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 Intervention
Carcinoma, Non-Small Cell Lung
Procedure: Endobronchial ultrasound (EBUS)
Procedure: Mediastinoscopy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • The primary outcome measure of the study is to compare the sensitivity of EBUS-TBNA vs. mediastinoscopy. [ Time Frame: 1 month interval ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 138
Study Start Date: March 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Endobronchial ultrasound (EBUS)
    Minimally invasive technique to stage lung cancers
    Procedure: Mediastinoscopy
    Traditional surgical method to stage lung cancers
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01079520

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Sang-Won Um, MD Samsung Medical Center
  More Information

No publications provided

Responsible Party: Sang-Won Um, Assistant Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01079520     History of Changes
Other Study ID Numbers: 2009-08-053, CRS110-19-1
Study First Received: January 20, 2010
Last Updated: October 31, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
Cancer
Lung Cancer
Ultrasound
Surgery

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014