Minimally Invasive, Diagnosis and Staging of Lung Cancer
|ClinicalTrials.gov Identifier: NCT01011595|
Recruitment Status : Completed
First Posted : November 11, 2009
Last Update Posted : June 21, 2012
The gold standard techniques to assess the extent of disease and decide on therapy for patients with lung cancer consists of cervical mediastinoscopy, which is a surgical procedure which entails an incision in the neck and the removal of lymph nodes from around the airway. Endobronchial ultrasound (EBUS) and endoscopic ultrasound (EUS) are new, non-surgical techniques that have been available for the past several years and are proving invaluable in lung cancer evaluation. These techniques are minimally invasive and can be performed without surgery.
To date, there have been no head-to-head studies on the same group of patients using both the old and new techniques. The study will consist of a study which compares traditional staging techniques in lung cancer patients to new, less invasive techniques.
The significance of the proposed project is tremendous. If the new strategies prove to be equivalent (or superior) to traditional techniques, these techniques will be considered the new gold-standard tests. This will change the way lung cancer is evaluated. An equivalent or superior result will also significantly impact on patient care, cost and morbidity due to the speed, convenience and lack of operating room requirement as well as the lack of general anesthesia.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Procedure: Cervical Mediastinoscopy Procedure: Endobronchial Ultrasound (EBUS) Procedure: Endoscopic Ultrasound (EUS)||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||166 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Minimally Invasive, Trans-Luminal Diagnosis and Staging of Lung Cancer: A Prospective Head-to-Head Comparison With Traditional Gold Standard Diagnostic Techniques|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||June 2012|
- Procedure: Cervical Mediastinoscopy
Surgical Meciastinal Lymph Node StagingOther Name: conventional staging procedure
- Procedure: Endobronchial Ultrasound (EBUS)
Minimally Invasive Echo-Bronchoscopic Lymph Node Evaluation and BiopsyOther Name: Minimally invasive mediastinal staging
- Procedure: Endoscopic Ultrasound (EUS)
Minimally Invasive Echo-Endoscopic Lymph Node Evaluation and BiopsyOther Name: Minimally invasive mediastinal staging
- The primary outcome measure will be the accuracy of the combination of minimally invasive diagnostic tests to correctly diagnose the presence or absence of mediastinal lymph node metastases compared to mediastinoscopy. [ Time Frame: 3-6 months ]Define and compare the sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratio and accuriacies between traditional and minimally invasive mediastinal diagnostic and staging techniques for lung cancer.
- The safety of all diagnostic techniques will be evaluated and compared between techniques. [ Time Frame: 3-6 months ]Compare morbidity, convenience, cost and efficiencies between traditional and minimally invasive diagnostic strategies.
- Procedure-related morbidity [ Time Frame: 3-6 months ]
- Procedural, hopsitalization and overall cost [ Time Frame: termination of enrollment ]
- Clinical decision making realted to diagnostic technique results. [ Time Frame: termination of enrollment ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01011595
|Centre Hospitalier de l'Université de Montréal|
|Montreal, Quebec, Canada, H2L 4M1|
|Principal Investigator:||Moishe Liberman, MD, PhD||Centre hospitalier de l'Université de Montréal (CHUM)|