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

Minimally Invasive Mediastinal Staging of Potentially Operable Lung Cancer With Endobronchial Ultrasound Guided Transbronchial Needle Aspiration(EBUS-TBNA) and Transesophageal Aspiration Using Ultrasonic Bronchoscope (EUS-B-FNA)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00741247

Enrollment

150

Registered

2008-08-26

Start date

2008-08-31

Completion date

2009-03-31

Last updated

2009-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

staging, Endobronchial ultrasound, Endoscopic ultrasound

Brief summary

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.

Interventions

PROCEDUREEBUS-TBNA, EUS-B-FNA (EUS-FNA with bronchoscope)

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).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The diagnostic values of EBUS-TBNA plus EUS-B-FNA as compared to EBUS-TBNA alone	June 2009

Secondary

Measure	Time frame
The Proportion and the location of lymph nodes accessible by EBUS-TBNA and EUS-B-FNA.	June 2009

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026