Clinical trial NCT01079520: Endobronchial Ultrasound- Transbronchial Needle Aspiration (EBUS-TBNA) Versus Mediastinoscopy for Mediastinal Lymph Node Staging of Non-small Cell Lung Cancer (NSCLC)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carcinoma, Non-Small Cell Lung
Keywords: Cancer
Lung Cancer
Ultrasound
Surgery
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-03-03
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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)

Primary outcomes:
measure: The primary outcome measure of the study is to compare the sensitivity of EBUS-TBNA vs. mediastinoscopy.
timeFrame: 1 month interval
Secondary outcomes:
measure: 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.
timeFrame: 1 month interval
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Sang-Won Um, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.