Endosonography for Mediastinal Nodal Staging of Clinical N1 Non-small Cell Lung Cancer A Prospective Multicenter Study

BACKGROUND: Patients with clinical N1 (cN1) lung cancer based on imaging are at risk for malignant mediastinal nodal involvement (N2 disease). Endosonography with a needle technique is suggested over surgical staging as a best fi rst test for preoperative invasive mediastinal staging. Th e addition of a confi rmatory mediastinoscopy seems questionable in patients with a normal mediastinum on imaging. Th is prospective multicenter trial investigated the sensitivity of preoperative linear endosonography and mediastinoscopy for mediastinal nodal staging of cN1 lung cancer. METHODS: Consecutive patients with operable and resectable cN1 non-small cell lung cancer underwent a lobe-specifi c mediastinal nodal staging by endosonography. Th e primary study outcome was sensitivity to detect N2 disease. Th e secondary end points were the prevalence of N2 disease, the negative predictive value (NPV) of both endosonography and endosonography with confi rmatory mediastinoscopy, and the number of patients needed to detect one additional N2 disease with mediastinoscopy. RESULTS: Of the 100 patients with cN1 on imaging, 24 patients were diagnosed with N2 disease. Invasive mediastinal nodal staging with endosonography alone has a sensitivity of 38%, which can be increased to 73% by adding a mediastinoscopy. NPV was 81% and 91%, respectively. Ten mediastinoscopies are needed to detect one additional N2 disease missed by endosonography. CONCLUSIONS: Endosonography alone has an unsatisfactory sensitivity to detect mediastinal nodal metastasis in cN1 lung cancer, and the addition of a confi rmatory mediastinoscopy is of added value.