Christophe Dooms1, Kurt G Tournoy2, Olga Schuurbiers3, Herbert Decaluwe4, Frédéric De Ryck5, Ad Verhagen6, Roel Beelen7, Erik van der Heijden8, Paul De Leyn4. 1. Respiratory Division, University Hospitals Leuven, Leuven, Belgium. Electronic address: christophe.dooms@uzleuven.be. 2. The Department of Pneumology, University Hospital Ghent, Ghent, Belgium. 3. Respiratory Division, University Hospitals Leuven, Leuven, Belgium. 4. The Department of Thoracic Surgery, University Hospitals Leuven, Leuven, Belgium. 5. The Department of Thoracic Surgery, University Hospital Ghent, Ghent, Belgium. 6. Respiratory Division, University Hospitals Leuven, Leuven, Belgium; Department of Pneumology, Radboud University Medical Center Nijmegen, Nijmegen, The Netherlands. 7. The Department of Thoracic Surgery, University Hospital Ghent, Ghent, Belgium; Department of Pneumology, OLV Ziekenhuis Aalst, Aalst, Belgium. 8. Respiratory Division, University Hospitals Leuven, Leuven, Belgium; Department of Cardiothoracic Surgery, OLV Ziekenhuis Aalst, Aalst, Belgium.
Abstract
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 first test for preoperative invasive mediastinal staging. The addition of a confirmatory mediastinoscopy seems questionable in patients with a normal mediastinum on imaging. This 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-specific mediastinal nodal staging by endosonography. The primary study outcome was sensitivity to detect N2 disease. The secondary end points were the prevalence of N2 disease, the negative predictive value (NPV) of both endosonography and endosonography with confirmatory 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 confirmatory mediastinoscopy is of added value. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01456429; URL: www.clinicaltrials.gov.
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 first test for preoperative invasive mediastinal staging. The addition of a confirmatory mediastinoscopy seems questionable in patients with a normal mediastinum on imaging. This prospective multicenter trial investigated the sensitivity of preoperative linear endosonography and mediastinoscopy for mediastinal nodal staging of cN1lung cancer. METHODS: Consecutive patients with operable and resectable cN1 non-small cell lung cancer underwent a lobe-specific mediastinal nodal staging by endosonography. The primary study outcome was sensitivity to detect N2 disease. The secondary end points were the prevalence of N2 disease, the negative predictive value (NPV) of both endosonography and endosonography with confirmatory 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 cN1lung cancer, and the addition of a confirmatory mediastinoscopy is of added value. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01456429; URL: www.clinicaltrials.gov.
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