Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS-TBNA) for Mediastinal Re-staging of Non-small Cell Lung Cancer(NSCLC)

Study Overview
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Brief Summary
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The aim of this study is to determine the diagnostic values of EBUS-TBNA in the mediastinal re-staging after induction treatment in patients with non-small cell lung cancer. Primary objective: 1. To determine the sensitivity, specificity, positive predictive value, negative predictive value and the accuracy of EBUS-TBNA in the detection of mediastinal metastasis in mediastinal re-staging after induction treatment. Secondary objectives: To compare the diagnostic values of EBUS-TBNA and integrated PET/CT in mediastinal re-staging To evaluate the changes of ultrasonographic features of mediastinal lymph nodes after induction therapy To determine procedure related complications

Official Title
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Endobronchial Ultrasound Guided Transbronchial Needle Aspiration for the Mediastinal Re-staging After Induction Therapy in Non-small Cell Lung Cancer. A Prospective Study

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Procedure: EBUS-TBNA, integrated PET/CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven non-small cell lung cancer Patients who have initially histologically proven N2 disease (Stage IIIA) Patients who underwent induction treatment (chemotherapy or chemoradiation therapy) and are considred for surgery Written informed consent Exclusion Criteria: Contraindications for bronchoscopy Medically inoperable patients Patients who are found to have M1 disease, inoperable T4 disease or supraclavicular metastasis after induction treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EBUS-TBNA<br> | Procedure: EBUS-TBNA, integrated PET/CT<br>* EBUS-TBNA and integrated PET/CT will be performed for patients with non-small cell lung cancer after induction therapy. PET/CT will be performed before EBUS-TBNA. Negative findings of EBUS-TBNA will be evaluated by surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The diagnostic values of EBUS-TBNA in the mediastinal re-staging after induction treatment in non-small cell lung cancer. |  | 1.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The diagnostic values of integrated PET/CT in the mediastinal re-staging after induction treatment in non-small cell lung cancer |  | 1.5 years | 
| The changes of ultrasonographic features of mediastinal lymph nodes after induction therapy |  | 1.5 years |