Endobronchial Ultrasound vs Mediastinoscopy in NSCLC

This study has been completed.
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00372203
First received: September 4, 2006
Last updated: June 7, 2012
Last verified: June 2012
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Prospective Controlled Trial of Mediastinoscopy Compared With Endobronchial Ultrasound Guided Transbronchial Needle Aspiration for Assessment of the Mediastinum in Lung Cancer.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Sensitivity [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: July 2006
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Endobronchial Ultrasound Guided Transthoracic Needle Biopsy
    Endobronchial Ultrasound Guided Transthoracic Needle Biopsy of mediastinal lymph nodes at the time of the mediastinoscopy.
  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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00372203

Locations
Canada, Ontario
University Health Network (Toronto General Hospital)
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Shaf Keshavjee, MD MSc FRCSC FACS University Health Network, Toronto
  More Information

No publications provided

Responsible Party: Dr. Shaf Keshavjee, University Health Network
ClinicalTrials.gov Identifier: NCT00372203     History of Changes
Other Study ID Numbers: 06-0085-A
Study First Received: September 4, 2006
Last Updated: June 7, 2012
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014