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

Carcinoma, Non-Small Cell Lung Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01079520
• Other study ID #: 2009-08-053
• Secondary ID: CRS110-19-1
• Status: Completed
• Phase: N/A
• First received: January 20, 2010
• Last updated: October 31, 2012
• Start date: March 2010
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma, Non-Small Cell Lung
• Carcinoma, Non-Small-Cell Lung

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure of the study is to compare the sensitivity of EBUS-TBNA vs. mediastinoscopy.		1 month interval	No
Secondary	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.		1 month interval	No