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

N

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Withdrawn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)

0 participants in 1 patient group

EBUS-TBNA
Experimental group
Treatment:
Procedure: EBUS-TBNA, integrated PET/CT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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