Endobronchial Ultrasound/Transbronchial Needle Aspiration-Biopsy for Systematic Mediastinal lymph Node Staging of Non-Small Cell Lung Cancer in Patients Eligible for Surgery: A Prospective Multicenter Study

SIMPLE SUMMARY: Histological and/or cytological evaluation of the mediastinal lymph nodes is essential for the successful treatment of lung cancer. This study analyzes the role of endobronchial ultrasound (EBUS) in the preoperative staging of non-small cell lung cancer. We carried out a prospective study between December 2019 and December 2022 on 217 lung cancer patients eligible for surgical resection. The lymph nodes biopsied, the number of samples, and the likelihood ratio for positive and for negative outcomes were the variables considered. All patients were discharged from hospital on day one. A downstaging and upstaging were noted in 16 patients (8 and 8, respectively, 7.4%). The sensitivity, specificity, positive and negative predictive value, and diagnostic accuracy were 90%, 90%, 82%, 94%, and 90%, respectively. The likelihood ratio for positive and negative results confirmed cancer when present, excluding it when absent. EBUS is the only minimally invasive and easy procedure for mediastinal staging. The direct visualization of the vessels, especially if posterior to the lymph node, allows for method-checking at every step and makes it safe and effective. Therefore, the endoscopist and the histologist/cytologist must have carried out an adequate learning curve in order not to negatively affect the method. ABSTRACT: Background: The treatment of lung cancer depends on histological and/or cytological evaluation of the mediastinal lymph nodes. Endobronchial ultrasound/transbronchial needle aspiration-biopsy (EBUS/TBNA-TBNB) is the only minimally invasive technique for a diagnostic exploration of the mediastinum. The aim of this study is to analyze the reliability of EBUS in the preoperative staging of non-small cell lung cancer (NSCLC). Methods: A prospective study was conducted from December 2019 to December 2022 on 217 NSCLC patients, who underwent preoperative mediastinal staging using EBUS/TBNA-TBNB according to the ACCP and ESTS guidelines. The following variables were analyzed in order to define the performance of the endoscopic technique—comparing the final staging of lung cancer after pulmonary resection with the operative histological findings: clinical characteristics, lymph nodes examined, number of samples, and likelihood ratio for positive and negative outcomes. Results: No morbidity or mortality was noted. All patients were discharged from hospital on day one. In 201 patients (92.6%), the preoperative staging using EBUS and the definitive staging deriving from the evaluation of the operative specimen after lung resection were the same; the same number of patients were detected in downstaging and upstaging (8 and 8, 7.4%). The sensitivity, specificity, positive and negative predictive value, and diagnostic accuracy were 90%, 90%, 82%, 94%, and 90%, respectively. The likelihood ratio for positive and negative results was 9 and 0.9, respectively, confirming cancer when present and excluding it when absent. Conclusions: EBUS is the only low-invasive and easy procedure for mediastinal staging. The possibility to check the method in each of its phases—through direct visualization of the vessels regardless of their location in relation to the lymph nodes—makes it safe both for the endoscopist and for the patient. Certainly, the cytologist/histologist and/or operator must have adequate expertise in order not to negatively affect the outcome of the method, although three procedures appear to reduce the impact of the individual professional involved on performance.