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Endobronchial Ultrasound vs Mediastinoscopy in NSCLC

This study is currently recruiting participants.
Verified by University Health Network, Toronto, February 2007

Sponsored by: University Health Network, Toronto
Information provided by: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00372203
  Purpose

Proper staging of Lung cancer is of paramount concern when determining a treatment regime. Currently the assessment of surgical candidacy is performed with the staging process, mainly the mediastinoscopy. A mediastinoscopy has the ability to access samples of the paratracheal lymph node stations (Levels 2R, 2L, 3, 4R, 4L), as well as the anterior subcarinal lymph node station (Level 7). In comparison, the EBUS-TBNA technique is a real-time procedure that has the potential to access the same paratracheal and subcarinal lymph node stations associated with the mediastinoscopy, but also extending out to the hilar lymph nodes (Levels 10 and 11). Because of the possibility of extended sampling range and a reduction in procedural invasiveness, EBUS-TBNA may represent a more efficient patient centered alternative to mediastinoscopy in the staging of lung cancer patients. Additionally, patients who are have lymph nodes in the N2 region frequently undergo chemotherapy and/or radiotherapy prior to surgery. Assessment of the lymph nodes after chemo/radiation is done using CT scans, as re-mediastinoscopy is a technically difficult procedure. These patients may benefit from EBUS-TBNA.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Procedure: Endobronchial Ultrasound Guided Transthoracic Needle Biopsy
Phase II

MedlinePlus related topics:   Cancer    Lung Cancer    Ultrasound   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:   Prospective Controlled Trial of Mediastinoscopy Compared With Endobronchial Ultrasound Guided Transbronchial Needle Aspiration for Assessment of the Mediastinum in Lung Cancer.

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Sensitivity

Estimated Enrollment:   180
Study Start Date:   July 2006

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

A) Age 18 years or older B) Patients with confirmed or suspected non-small cell lung cancer who require a mediastinoscopy as part of their staging investigations of the mediastinum to determine suitability for lung cancer resection will be considered for the trial.

C) Patients with undiagnosed enlarged lymph nodes in the mediastinum suspicious for lung cancer in which a tissue diagnosis is required.

Exclusion Criteria:

A) Patients who are deemed on clinical grounds not to be medically fit for a bronchoscopy or a mediastinoscopy or who are not suitable for definitive surgical resection by thoracotomy will be excluded.

B) Patients who have verified stage IV disease or who are not appropriate for lung cancer resection by virtue of direct invasion of mediastinal structures or large parts of the chest wall.

C) Known small cell lung cancer. D) Patients where there is a high clinical suspicion of lymphoma. E) Inability to give informed consent.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00372203

Contacts
Contact: Devon Chafe     416-340-4800 ext 5446     Devon.Chafe@uhn.on.ca    
Contact: Jennifer Hornby, BSc CCRP     416-340-4857     Jennifer.Hornby@uhn.on.ca    

Locations
Canada, Ontario
University Health Network (Toronto General Hospital)     Recruiting
      Toronto, Ontario, Canada, M5G 2C4
      Contact: Devon Chafe     416-340-4800 ext 5446     Devon.Chafe@uhn.on.ca    
      Contact: Jennifer Hornby, BSc CCRP     416-340-4857     Jennifer.Hornby@uhn.on.ca    
      Principal Investigator: Shaf Keshavjee, MD MSc FRCSC FACS            

Sponsors and Collaborators
University Health Network, Toronto

Investigators
Principal Investigator:     Shaf Keshavjee, MD MSc FRCSC FACS     University Health Network, Toronto    
  More Information


Study ID Numbers:   06-0085-A
First Received:   September 4, 2006
Last Updated:   February 28, 2007
ClinicalTrials.gov Identifier:   NCT00372203
Health Authority:   Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Non-small cell lung cancer  
NSCLC  
EBUS  
Endobronchial ultrasound  
mediastinoscopy  

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 16, 2008




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