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Risk Factors of Medistinal Metastasis in Endoscopic Staging of Lung Cancer

N

National Cancer Center (NCC)

Status

Active, not recruiting

Conditions

Non Small Cell Lung Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT02991924
NCC2016-0156

Details and patient eligibility

About

The purpose of this study is to investigate risk factors for mediastinal lymph node metastasis in potentially operable non-small cell lung cancer in order to find indications for endoscopic mediastinal staging. Chest CT, integrated PET/CT, and endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) +/- endoscopic ultrasound with bronchoscope-guided fine needle aspiration (EUS-B-FNA) are performed for mediastinal staging. CT and PET/CT findings, histologic types and other risk factors will be analyzed. The investigators develop the prediction method for mediastinal metastasis.

Enrollment

600 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Histologically confirmed or strongly suspected non-small cell lung cancer (NSCLC)
  • Potentially operable

Exclusion criteria

  • M1 disease
  • Inoperable T4 disease
  • Mediastinal infiltration or extranodal invasion of the mediastinal lymph node visible on chest CT
  • Confirmed supraclavicular lymph node metastasis
  • Pancoast tumours
  • T1 ground glass opacity nodule (with solid part 1<cm)
  • Solid T1 (1<cm)N0 M0 by CT & PET/CT
  • Inoperable patients (after evaluating medical and surgical operability)
  • Patients who refused surgical treatment
  • Contraindications for bronchoscopy
  • Drug reaction to lidocaine, midazolam, fentanyl
  • Pregnancy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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