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Prospective Controlled Trial of Mediastinoscopy Compared With Endobronchial Ultrasound Guided Transbronchial Needle Aspiration for Assessment of the Mediastinum in Lung Cancer.


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-small Cell Lung Cancer

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Trial Information

Prospective Controlled Trial of Mediastinoscopy Compared With Endobronchial Ultrasound Guided Transbronchial Needle Aspiration for Assessment of the Mediastinum in Lung Cancer.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Sensitivity

Outcome Time Frame:

1 day

Safety Issue:

No

Principal Investigator

Shaf Keshavjee, MD MSc FRCSC FACS

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Toronto

Authority:

Canada: Health Canada

Study ID:

06-0085-A

NCT ID:

NCT00372203

Start Date:

July 2006

Completion Date:

March 2010

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non-small cell lung cancer
  • NSCLC
  • EBUS
  • Endobronchial ultrasound
  • mediastinoscopy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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