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Evaluation of Endobronchial Ultrasound (EBUS) for Staging Lung Cancer (EBUS)

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ClinicalTrials.gov Identifier: NCT01799980
Recruitment Status : Completed
First Posted : February 27, 2013
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Study Description
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Brief Summary:
This study will compare two different methods of staging lung cancer to determine whether endobronchial ultrasound (EBUS) staging of mediastinal lymph nodes will provide good diagnostic yield in detecting lung cancer, when compared to current methods of a staging bronchoscopy and cervical mediastinoscopy.

Condition or disease
Lung Cancer

Study Design
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Study Type : Observational
Actual Enrollment : 37 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Endobronchial Ultrasound (EBUS) for Staging Lung Cancer
Study Start Date : June 2012
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Groups and Cohorts
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Group/Cohort
Cervical mediastinoscopy
This group will undergo cervical mediastinoscopy before surgery to stage their lung cancer (procedure decided by the surgeon).
Endo-bronchial ultrasound
This group will undergo endobronchial ultrasound before surgery to stage their lung cancer (procedure decided by the surgeon).


Outcome Measures
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Primary Outcome Measures :
  1. Lung cancer staging [ Time Frame: Pre-op and post-op ]
    Lung cancer staging (assessed by either cervical mediastinoscopy or EBUS) will be compared both pre-op and post-op.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing a staging procedure for lung cancer (either cervical mediastinoscopy or endobronchial ultrasound).
Criteria

Inclusion Criteria:

Patients, > 18 years of age,

Gender- Males and Female

Diagnosis of Non Small Cell Lung Cancer.

Patients who have consented on an Ottawa Hospital consent form to undergo a mediastinoscopy procedure or EBUS-TBNA, and a Positron emission tomography (PET) of the chest for lung cancer staging.

Exclusion Criteria:

Females who are pregnant (or found to be pregnant) during the course of this research study.

Patients who do not provide their Ottawa Hospital consent to undergo a staging bronchoscopy , cervical mediastinoscopy or EBUS-TBNA.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799980


Locations
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Canada, Ontario
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
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Principal Investigator: Donna E Maziak, MD, MSc Ottawa Hospital Research Institute
More Information
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01799980    
Other Study ID Numbers: 2009471-01H
First Posted: February 27, 2013    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Keywords provided by Ottawa Hospital Research Institute:
Lung cancer
Cervical mediastinoscopy
Endobronchial ultrasound
Staging
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases