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

Sponsored by:	National Cancer Center, Korea
Information provided by:	National Cancer Center, Korea
ClinicalTrials.gov Identifier:	NCT00741247

Purpose

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.

Condition	Intervention
Lung Cancer	Procedure: EBUS-TBNA, EUS-B-FNA (EUS-FNA with bronchoscope)

MedlinePlus related topics: Cancer Lung Cancer Ultrasound

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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)

Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:

The diagnostic values of EBUS-TBNA plus EUS-B-FNA as compared to EBUS-TBNA alone [ Time Frame: June 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The Proportion and the location of lymph nodes accessible by EBUS-TBNA and EUS-B-FNA. [ Time Frame: June 2009 ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	August 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00741247

Contacts

Contact: Bin Hwangbo, Dr

82-31-920-1115

hbb@ncc.re.kr

Locations

Korea, Republic of
NCCKorea	Recruiting
Gyeonggi-do, Korea, Republic of
Contact: Soyoung Ju, secretary +82-31-920-0425 syju@ncc.re.kr

Sponsors and Collaborators

National Cancer Center, Korea

More Information

Responsible Party:	National Cancer Center, Korea ( National Cancer Center, Korea )
Study ID Numbers:	NCCCTS-08-332
Study First Received:	August 25, 2008
Last Updated:	August 28, 2008
ClinicalTrials.gov Identifier:	NCT00741247
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by National Cancer Center, Korea:

staging
Endobronchial ultrasound
Endoscopic ultrasound

Study placed in the following topic categories:

Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009