Evaluation of Preoperative Endobronchial Ultrasound (EBUS) in Non Small Cell Lung Cancer (NSCLC)
Completed
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Procedure: EBUS
- Registration Number
- NCT00960271
- Lead Sponsor
- University Hospital, Rouen
- Brief Summary
This study aims to assess both the role and cost-effectiveness of EBUS in preoperative Non small cell lung cancer staging. This controlled multicentric study will be conducted in 22 centers in France. The study design includes two prospective phases. In phase 1, one investigator in each center will prospectively be evaluated for its ability to perform EBUS, with a required goal of 9 informative samplings out of 10 consecutive patients. The phase 2 will include the medico-economic assessment of the technique in the preoperative setting. A maximum of 420 patients for each phase is forecasted.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 363
Inclusion Criteria
- adult patients over 18
- non small cell lung cancer histologically or cytologically proved
- Clinical Stage IIIA
- anatomically and functionally resectable
Exclusion Criteria
- uncorrected bleeding disorders
- absence of lymphadenopathy superior to 1cm in small axis at CT scan
- contraindication to bronchoscopy
- extrathoracic or intrathoracic metastasis
- respiratory function tests not compatible with curative resection of lung cancer
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description NON SMALL CELL LUNG CANCER EBUS Non small cell lung cancer, with clinical N2 disease, otherwise operable.
- Primary Outcome Measures
Name Time Method number of mediastinoscopy avoided 24h
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Rouen University Hospital
🇫🇷Rouen, France