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

National Cancer Center (NCC)

Status: Withdrawn

Conditions: Non Small Cell Lung Cancer

Treatments: Procedure: EBUS-TBNA, integrated PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT00859742

NCCTS-06-211

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

EBUS-TBNA

Experimental group

Treatment:

Procedure: EBUS-TBNA, integrated PET/CT