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

• Sponsor: National Cancer Center, Korea (Other)
• Overall Status: Completed
• CT.gov ID: NCT00741247
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Duration (Months): 7
• Patients Per Site Per Month: 21.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Procedure: EBUS-TBNA, EUS-B-FNA (EUS-FNA with bronchoscope)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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)
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Outcome Measures

Primary Outcome Measures

1. The diagnostic values of EBUS-TBNA plus EUS-B-FNA as compared to EBUS-TBNA alone [June 2009]

Secondary Outcome Measures

1. The Proportion and the location of lymph nodes accessible by EBUS-TBNA and EUS-B-FNA. [June 2009]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	NCCKorea	Gyeonggi-do		Korea, Republic of

Sponsors and Collaborators

• National Cancer Center, Korea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00741247
• Other Study ID Numbers: NCCCTS-08-332
• First Posted: Aug 26, 2008
• Last Update Posted: Jun 24, 2009
• Last Verified: Jun 1, 2009

• Keywords provided by , ,: staging; Endobronchial ultrasound; Endoscopic ultrasound
• Additional relevant MeSH terms: Lung Neoplasms

Study Results

No Results Posted as of Jun 24, 2009