Comparison between Wedge Resection and Segmentectomy for Ground Glass Opacity-dominant Early Stage Non-Small Cell Lung Cancer (TSCI 002): Study protocol for a randomized controlled trial

Background: Currently, there are no universally recognized criteria to choose between segmentectomy and wedge resection. However, compared with segmentectomy, wedge resection is more accessible, less invasive, preserves more pulmonary tissues and presents a faster post-operative recovery process, which in turn, result in a higher quality of life. We hypothesize that wedge resection could be a potential alternative to anatomic segmentectomy for patients with very early non-small cell lung cancer (NSCLC), and we plan to conduct the first randomized trial comparing the effectiveness and safety of wedge resection and segmentectomy to guide the surgical decision. Methods: We plan to conduct a prospective, multicentre, randomized, open, parallel control and non-inferiority verification adopted study. Patients from 21 sites of China who satisfy all the inclusion criteria and do not fall into any of the exclusion criteria are qualified to be included in this study. They will then be randomly allocated into two groups: lung wedge resection + hilar and mediastinal lymph node resection / sampling (study group) and segmentectomy + hilar and mediastinal lymph node resection/sampling (control group). A recruitment period of no more than two years is anticipated. The primary endpoint of the study is 5-year disease-free survival (DFS) between the two groups. The secondary endpoints are 3-year DFS, 5-year overall survival （OS）, 30-day morbidity and mortality rates, and pulmonary function. Discussion: This is a multi-centre, randomized, open, parallel control, and non-inferiority verification adopted study to evaluate whether lung wedge resection and segmentectomy are equivalent in long-term oncological efficacy in patients with ground glass opacity (GGO)-dominant early stage peripheral non-small cell lung cancer.