One-stage versus two-stage video-assisted thoracic surgery for synchronous bilateral pulmonary nodules: protocol for a prospective, multicentre, randomised controlled clinical trial in China (OTVATS-2)

INTRODUCTION: With the increasing detection of synchronous bilateral pulmonary nodules in clinical practice, both one-stage and two-stage video-assisted thoracic surgery (VATS) have been widely applied. This study protocol describes the OTVATS-2 trial, which aims to compare perioperative complications and long-term outcomes between these two surgical strategies. METHODS AND ANALYSIS: A prospective, multicentre, randomised controlled clinical trial will be conducted to compare the surgical outcomes of one-stage versus two-stage VATS in patients with synchronous bilateral pulmonary nodules. A total of 256 patients will be enrolled from three academic institutions in China. This trial is expected to last for 2 years, with patient recruitment starting in July 2025. The primary outcome is perioperative complication rate within 30 days. Secondary outcomes including 5-year overall survival, 5-year disease-free survival, surgical time, blood loss, duration of chest tube, length of stay, postoperative pain scores, quality of life scores as well as anxiety and depression scores. ETHICS AND DISSEMINATION: This study has been approved by the Ethics Committee of China-Japan Friendship Hospital (No. 2025-KY-150) and the institutional review boards of all participating centres, including the Ethics Committees of Peking University Third Hospital and Beijing Hospital. Written informed consent will be obtained from all enrolled participants. Results of the research will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ChiCTR 2500106215.