Non Small Cell Lung Cancer
Conditions
Keywords
Non-small cell lung cancer, mediastinal lymph node, resectable, EBUS, stage IIIA, significant mediastinal lymph node at thoracic CT Scan
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.
Interventions
PROCEDUREEBUS
a minimally invasive technique of mediastinal lymph node staging using an integrated videoendoscopic device equipped with ultrasound for the localization and transbronchial sampling of lymph nodes in real time
Sponsors
University Hospital, Rouen
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of mediastinoscopy avoided | 24h |
Countries
France
Outcome results
None listed