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Completed

NCT Number: NCT01079520

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

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.

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Key information

Conditions

Carcinoma, Non-small Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Endobronchial Ultrasound (EBUS)

Procedure

Minimally invasive technique to stage lung cancers

Mediastinoscopy

Procedure

Traditional surgical method to stage lung cancers

Primary outcomes

  1. The primary outcome measure of the study is to compare the sensitivity of EBUS-TBNA vs. mediastinoscopy.

    Time frame: 1 month interval

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

A Prospective Trial of Endobronchial Ultrasound- Transbronchial Needle Aspiration Compared to Mediastinoscopy for Mediastinal Lymph Node Staging of Non-small Cell Lung Cancer

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 3, 2010
Registry last updated
Nov 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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