Comparison of the Diagnostic Efficiency of Mediastinal Lymph Node Endobronchial and Endoesophageal Ultrasound with Transcervical Extended Mediastinal Lymphadenectomy in Operable Non-Small Cell Lung Cancer.

Objectives: The aim of the study was to compare the diagnostic efficiency between combined endobronchial ultrasound (EBUS)/endoesophageal ultrasound (EUS) and transcervical extended mediastinal lymphadenectomy (TEMLA) for preoperative staging of mediastinal lymph nodes in non-small cell lung cancer (NSCLC). Material and Methods: Between June 2011 and December 2017, a single-institution prospective randomized trial was conducted, and 250 patients with cytologically confirmed NSCLC, clinical stages cI-IIIA, were included. Positron emission tomography/computed tomography (PET/CT) was performed in all patients. After exclusions, 204 patients were randomized into the EBUS/EUS or TEMLA arms. Patients without N2/N3 metastases after mediastinal staging underwent surgery. The diagnostic yield and complication rates of the EBUS/EUS and TEMLA groups were compared. Results: There were 103 patients in the EBUS/EUS group, and N2 metastases were found in nine cases (8.7%). Ninety-four patients underwent surgery; in six cases, previously unsuspected N2 metastases were revealed. One hundred and one patients were randomized to the TEMLA group, which detected N2/N3 metastases in 15 cases (15.1%). Three patients were not operated on due to postoperative complications following TEMLA. Eighty-three patients underwent surgery, and a single N2 metastatic nodule was detected in one case. The diagnostic sensitivity, specificity, accuracy, PPV, and NPV were 94%, 100%, 99%, 100%, and 99% for TEMLA, respectively, and 60%, 100%, 94%, 100%, and 94% for EBUS/EUS, respectively. There was a significant difference in sensitivity (60% vs. 94%) between the EBUS/EUS and TEMLA groups in favor of the TEMLA group. Postoperative complications occurred in 6/101 (6%) patients after TEMLA, while no complications were observed in the EBUS/EUS group. Conclusions: TEMLA demonstrated superior sensitivity for detecting N2/3 disease compared to EBUS/EUS in terms of diagnostic performance for mediastinal staging of cI-IIIA NSCLC. Due to its more invasive nature, TEMLA was associated with a higher number of complications compared with EBUS/EUS.