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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00859742
Enrollment
0
Registered
2009-03-11
Start date
2009-03-31
Completion date
2010-08-31
Last updated
2018-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

Brief summary

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

Interventions

PROCEDUREEBUS-TBNA, integrated PET/CT

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.

Sponsors

National Cancer Center, Korea
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

MeasureTime frame
The diagnostic values of integrated PET/CT in the mediastinal re-staging after induction treatment in non-small cell lung cancer1.5 years
The changes of ultrasonographic features of mediastinal lymph nodes after induction therapy1.5 years

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026