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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT00741247
First received: August 25, 2008
Last updated: June 23, 2009
Last verified: June 2009
History of Changes
  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)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

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 ]

Enrollment: 150
Study Start Date: August 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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).
  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

Locations
Korea, Republic of
NCCKorea
Gyeonggi-do, Korea, Republic of
Sponsors and Collaborators
National Cancer Center, Korea
  More Information

No publications provided by National Cancer Center, Korea

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT00741247     History of Changes
Other Study ID Numbers: NCCCTS-08-332
Study First Received: August 25, 2008
Last Updated: June 23, 2009
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by National Cancer Center, Korea:
staging
Endobronchial ultrasound
Endoscopic ultrasound

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013