Risk Factors of Medistinal Metastasis in Endoscopic Staging of Lung Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2026-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Non Small Cell Lung Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No