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| ID | Type | Description | Link |
|---|---|---|---|
| CRS110-19-1 | Other Grant/Funding Number | Samsung Medical Center Clinical Research Development Program |
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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endobronchial ultrasound (EBUS) | Procedure | Minimally invasive technique to stage lung cancers | ||
| Mediastinoscopy | Procedure | Traditional surgical method to stage lung cancers |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure of the study is to compare the sensitivity of EBUS-TBNA vs. mediastinoscopy. | 1 month interval |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sang-Won Um, MD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25611227 | Derived | 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. |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009369 | Neoplasms |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D008481 | Mediastinoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019616 | Thoracic Surgical Procedures |
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