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

Not Applicable
Withdrawn
Conditions
Non Small Cell Lung Cancer
Registration Number
NCT00859742
Lead Sponsor
National Cancer Center, Korea
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

Detailed Description

Not available

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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

Trial Locations

Locations (1)

NCCKorea

🇰🇷

Goyang, Gyeonggi-do, Korea, Republic of

NCCKorea
🇰🇷Goyang, Gyeonggi-do, Korea, Republic of

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