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

NCT ID: NCT01079520

Last Updated: 2012-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2012-10-31

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.

Conditions

Carcinoma, Non-Small Cell Lung

Keywords

Cancer; Lung Cancer; Ultrasound; Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

Endobronchial ultrasound (EBUS)

Minimally invasive technique to stage lung cancers

Intervention Type: PROCEDURE

Mediastinoscopy

Traditional surgical method to stage lung cancers

Intervention Type: PROCEDURE

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sang-Won Um

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sang-Won Um, MD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

References

Um SW, Kim HK, Jung SH, Han J, Lee KJ, Park HY, Choi YS, Shim YM, Ahn MJ, Park K, Ahn YC, Choi JY, Lee KS, Suh GY, Chung MP, Kwon OJ, Kim J, Kim H. Endobronchial ultrasound versus mediastinoscopy for mediastinal nodal staging of non-small-cell lung cancer. J Thorac Oncol. 2015 Feb;10(2):331-7. doi: 10.1097/JTO.0000000000000388.

Reference Type: DERIVED

PMID: 25611227 (View on PubMed)

Other Identifiers

CRS110-19-1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2009-08-053

Identifier Type: -

Identifier Source: org_study_id