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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
EBUS-TBNA, EUS-B-FNA (EUS-FNA with bronchoscope)
Sponsored by
National Cancer Center, Korea
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring staging, Endobronchial ultrasound, Endoscopic ultrasound

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • NCCKorea

Outcomes

Primary Outcome Measures

The diagnostic values of EBUS-TBNA plus EUS-B-FNA as compared to EBUS-TBNA alone

Secondary Outcome Measures

The Proportion and the location of lymph nodes accessible by EBUS-TBNA and EUS-B-FNA.

Full Information

First Posted
August 25, 2008
Last Updated
June 23, 2009
Sponsor
National Cancer Center, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT00741247
Brief Title
Mediastinal Staging of Lung Cancer With EBUS-TBNA and EUS-B-FNA
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 Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Center, Korea

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
staging, Endobronchial ultrasound, Endoscopic ultrasound

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
EBUS-TBNA, EUS-B-FNA (EUS-FNA with bronchoscope)
Intervention Description
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).
Primary Outcome Measure Information:
Title
The diagnostic values of EBUS-TBNA plus EUS-B-FNA as compared to EBUS-TBNA alone
Time Frame
June 2009
Secondary Outcome Measure Information:
Title
The Proportion and the location of lymph nodes accessible by EBUS-TBNA and EUS-B-FNA.
Time Frame
June 2009

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
NCCKorea
City
Gyeonggi-do
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
20348194
Citation
Hwangbo B, Lee GK, Lee HS, Lim KY, Lee SH, Kim HY, Lee HS, Kim MS, Lee JM, Nam BH, Zo JI. Transbronchial and transesophageal fine-needle aspiration using an ultrasound bronchoscope in mediastinal staging of potentially operable lung cancer. Chest. 2010 Oct;138(4):795-802. doi: 10.1378/chest.09-2100. Epub 2010 Mar 26.
Results Reference
derived

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

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