Carcinoma, Non-Small-Cell Lung Clinical Trial
Official title:
Complete Echo-Endoscopic Staging of Lung Cancer vs Surgical Staging: a Randomized Clinical Trial
Lung cancer is one of the most prevalent cancers and has a very high mortality. Both
treatment and prognosis depend on the staging. Surgical staging of the mediastinum mainly by
means of a cervical mediastinoscopy is the gold standard. Mediastinal staging is however a
field that undergoes a fast technological development. Transesophageal ultrasound guided
fine-needled aspiration (EUS-FNA) and an endobronchial ultrasound guided transbronchial
fine-needled aspiration (EBUS-TBNA) are two complementary endoscopic ultrasound techniques
which together allow cytological analysis of all mediastinal lymph nodes. This means that
the combination of both techniques enables a complete (bilateral) mediastinal investigation
(N2 and N3, except para-aortal station 6).
Hypothesis: complete endoscopic ultrasound staging identifies more patients with locally
advanced disease compared to surgical staging (current standard of care).
Study design: A randomized controlled multi-center double arm diagnostic phase III trial, in
which patients are randomly assigned to either surgical staging (arm B) or endoscopic
ultrasound staging with both EUS-FNA and EBUS-TBNA (arm A).
Arm A: Examination by EUS-FNA and EBUS-TBNA. These techniques are performed in an outpatient
one session setting under conscious sedation and take together about 30 to 60 minutes. If no
metastasis are shown, the patient undergoes a surgical staging procedure (for confirmation).
For reasons of convenience and patient-comfort, the EUS-FNA investigation is performed
before the EBUS-TBNA.
Arm B: Surgical staging with either cervical mediastinoscopy, parasternal mediastinoscopy,
thorascopic mediastinal exploration or exploratory thoracotomy, performed according to
institutional practice.
Patients in whom no lymph node metastasis are found proceed to thoracotomy with systematic
lymph node sampling to obtain an accurate intraoperative mediastinal staging.
Primary outcome: The assessment of N2-N3 lymph node metastases.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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