Minimally Invasive, Diagnosis and Staging of Lung Cancer
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Purpose
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 | Intervention |
|---|---|
|
Lung Cancer |
Procedure: Cervical Mediastinoscopy Procedure: Endobronchial Ultrasound (EBUS) Procedure: Endoscopic Ultrasound (EUS) |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Minimally Invasive, Trans-Luminal Diagnosis and Staging of Lung Cancer: A Prospective Head-to-Head Comparison With Traditional Gold Standard Diagnostic Techniques |
- 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]Compare morbidity, convenience, cost and efficiencies between traditional and minimally invasive diagnostic strategies.
- Procedure-related morbidity [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
- Procedural, hopsitalization and overall cost [ Time Frame: termination of enrollment ] [ Designated as safety issue: No ]
- Clinical decision making realted to diagnostic technique results. [ Time Frame: termination of enrollment ] [ Designated as safety issue: No ]
| Enrollment: | 166 |
| Study Start Date: | October 2009 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
-
Procedure: Cervical Mediastinoscopy
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Lung lesion with mediastinal lymphadenopathy* and/or positive PET scan in the mediastinum
- Lung lesion (>1cm) without mediastinal lymphadenopathy* or positive PET scan in the mediastinum
Exclusion Criteria:
- Age < 18 years old
- CT or PET positivity in an extra-thoracic site (adrenal, liver, brain, bone…)
- Indeterminate pulmonary nodule less than 1cm in diameter without mediastinal lymphadenopathy* on CT and a negative PET scan
- History of previous mediastinoscopy
- Biopsy proven positive mediastinal LN(s)
- Inability to consent for the study
- Cervical or thoracic anatomy precluding mediastinoscopy
- Inability to tolerate general anesthesia
- Pre-operative plan for carinal resection or carinal pneumonectomy (CM contraindicated prior to operative procedure due to additional difficulty secondary to scarring at time of resection)
- Active pulmonary infection (bronchitis, pneumonia)
- Active cutaneous infection overlying proposed surgical site(s)
Lymphadenopathy will be defined as short axis LN diameter of >10 mm on CT scan
Contacts and Locations| Canada, Quebec | |
| 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 |
More Information
No publications provided
| Responsible Party: | Centre hospitalier de l'Université de Montréal (CHUM) |
| ClinicalTrials.gov Identifier: | NCT01011595 History of Changes |
| Other Study ID Numbers: | CE 09.107 |
| Study First Received: | November 9, 2009 |
| Last Updated: | June 20, 2012 |
| Health Authority: | Canada: Ethics Review Committee Canada: Health Canada |
Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
|
lung cancer mediastinoscopy mediastinal lymph nodes staging |
EBUS EUS Endobronchial Ultrasound Endoscopic Ultrasound |
Additional relevant MeSH terms:
|
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 23, 2013