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

National Cancer Center, Korea

Overview

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: 1. To compare the diagnostic values of EBUS-TBNA and integrated PET/CT in mediastinal re-staging 2. To evaluate the changes of ultrasonographic features of mediastinal lymph nodes after induction therapy 3. To determine procedure related complications

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Non Small Cell Lung Cancer

Interventions

EBUS-TBNA, integrated PET/CTPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

NCCKorea

Goyang-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

The diagnostic values of EBUS-TBNA in the mediastinal re-staging after induction treatment in non-small cell lung cancer.

Time frame: 1.5 years

Secondary Outcomes

The diagnostic values of integrated PET/CT in the mediastinal re-staging after induction treatment in non-small cell lung cancer

Time frame: 1.5 years

The changes of ultrasonographic features of mediastinal lymph nodes after induction therapy

Time frame: 1.5 years

Data from ClinicalTrials.gov

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