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

Lung Cancer Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00741247
• Other study ID #: NCCCTS-08-332
• Status: Completed
• Phase: N/A
• First received: August 25, 2008
• Last updated: June 23, 2009
• Start date: August 2008
• Est. completion date: March 2009

Study information

• Verified date: June 2009
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Procedure:
• EBUS-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).

Locations

Country	Name	City	State
Korea, Republic of	NCCKorea	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The diagnostic values of EBUS-TBNA plus EUS-B-FNA as compared to EBUS-TBNA alone		June 2009	No
Secondary	The Proportion and the location of lymph nodes accessible by EBUS-TBNA and EUS-B-FNA.		June 2009	No