Non Small Cell Lung Cancer Clinical Trial
— EVIEPEBOfficial title:
Medico-economic Evaluation of a Preoperative Algorithm Including EBUS for NSCLC Initial Staging
Verified date | January 2013 |
Source | University Hospital, Rouen |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Institutional Ethical Committee |
Study type | Observational |
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.
Status | Completed |
Enrollment | 363 |
Est. completion date | December 2011 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
France | Rouen University Hospital | Rouen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Rouen |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | number of mediastinoscopy avoided | 24h | No |
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