Mediastinal Staging of Lung Cancer With EBUS-TBNA and EUS-B-FNA

National Cancer Center, Korea150 enrolled

Overview

The purpose of this study is to find a role of EUS-B-FNA in the mediastinal staging of potentially operable lung cancer. The investigators perform EBUS-TBNA and EUS-B-FNA on potentially operable lung cancer patients. The investigators perform EBUS(+/- TBNA) and EUS-B (ultrasonographic examination through the esophagus) on all subjects. EUS-B-FNA will be performed on inaccessible nodes or difficult nodes to be sampled by EBUS-TBNA. Additional diagnostic values of EUS-B-FNA as compared to EBUS-TBNA alone will be estimated.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

150

Conditions

Lung Cancer

Interventions

EBUS-TBNA, EUS-B-FNA (EUS-FNA with bronchoscope)PROCEDURE

EBUS-TBNA is a bronchoscopic diagnostic method that enables real time aspiration of paratracheal and peribronchial lesions. EUS-FNA is a procedure to obtain samples through the esophagus under real-time ultrasound guidance. In this study, EUS-FNA will be applied using a ultrasonic bronchoscope (EUS-B-FNA).

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically confirmed or strongly suspected potentially operable non-small cell lung cancer (NSCLC) * Potentially operable patients Exclusion Criteria: After staging work-up for NSCLC, including bronchoscopy,CT of the chest and upper abdomen, integrated PET/CT and brain MRI (and/or bone scan) * 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 tumors * Medically inoperable patients * Contraindications for bronchoscopy

Locations (1)

NCCKorea

Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

The diagnostic values of EBUS-TBNA plus EUS-B-FNA as compared to EBUS-TBNA alone

Time frame: June 2009

Secondary Outcomes

The Proportion and the location of lymph nodes accessible by EBUS-TBNA and EUS-B-FNA.

Time frame: June 2009

Data from ClinicalTrials.gov

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