Background: Safety and short-term efficacy of video-assisted thoracoscopic surgery (VATS) for early-stage non-small lung cancer (NSCLC) has been demonstrated by observational studies previously. However, these outcomes have never been verified by a large randomized controlled trial (RCT). The aim of our RCT was to confirm that VATS is not inferior or even superior to open operation for early-stage NSCLC in terms of short-term and oncologic efficacy.
Methods: The trial was undertaken at five tertiary hospitals. Patients aged between 18 and 75 years with clinically early-stage NSCLC were randomly assigned to the VATS and axillary thoracotomy groups. Lobectomy plus mediastinal lymph node dissection was standard surgical intervention. Because patients continue to be followed up for oncologic outcome, the short-term perioperative outcomes would be reported here.
Results: Between 2008 and 2014, 508 patients were recruited and 425 were eligible for analyses (215 VATS and 210 axillary thoracotomy). Eight VATS procedures were converted to open operation intraoperatively (3.72%). Median operation time with VATS was significantly less than axillary thoracotomy (150 versus 166 minutes, p = 0.009). In addition, VATS was associated with less intraoperative blood loss (p = 0.001). There was no difference for postoperative pleural drainage, length of hospitalization, and rates of morbidity and mortality. Cancer residual margins were found in 1 patient with VATS and 5 with axillary thoracotomy (p = 0.128). The yield of lymph nodes from either surgical approach was similar (p = 0.389).
Conclusions: Our study demonstrates that VATS lobectomy is safe and reliable to treat NSCLCs, and it may be superior to axillary thoracotomy for operation time and intraoperative blood loss. ClinicalTrials.gov identifier: NCT01102517.
Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.