Journal Article

Robot-assisted versus video-assisted thoracoscopic thymectomy for stage I–II thymic epithelial tumour: a protocol for the first multicentre, randomised controlled clinical trial

Ao, Yong-Qiang, Tan, Lijie, Liang, Fei, Zheng, Yuansheng, Yang, Xinyu, Sun, Zhenguo, Wang, Shuai, Gao, Jian, Yue, Weiming, Jiang, Jiahao, Ding, Jianyong, Wu, Bin, Jiang, Xifei, Zhu, Junkan, Qi, Yu

2025

Overview

BackgroundMinimally invasive approaches, including video-assisted thoracoscopic thymectomy (VATT) and robot-assisted thoracoscopic thymectomy (RATT), have emerged as alternatives to median sternotomy for resectable thymic epithelial tumours (TETs). However, their comparative clinical efficacy remains inconclusive due to limited prospective evidence. This phase II randomised controlled trial aims to provide the first direct comparative analysis of perioperative outcomes between RATT and VATT in stage I–II TETs.Methods and analysisThis phase II clinical trial is a prospective, multicentre, randomised controlled study. A total of 100 patients with stage I–II TETs will be recruited and randomly allocated into two groups: RATT and VATT groups, with a 1:1 ratio. Follow-up visits will be scheduled at 1 month, 3 months and 6 months postsurgery, and semiannual visits will continue until November 2027, including the record of tumour recurrence, metastasis, survival outcomes and overall long-term effects. The primary endpoint is total postoperative thoracic drainage. Secondary outcomes encompass intraoperative factors like R0 resection rate, operative time, postoperative drainage duration, hospital stay length, conversion rates, levels of stress markers, pain scores, quality of life assessments, perioperative complication rates, mortality rates and 3-year disease-free and overall survival rates.Ethics and disseminationThe study protocol is approved by the ethics committees of Zhongshan Hospital, Fudan University (No. B2024-365), and will be conducted under the guidance of the Helsinki Declaration. All data and findings will be disseminated and published through peer review.Trial registration numberNCT06654830.

• Publisher: British Medical Journal Publishing Group,BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Adult / Classification / Clinical Protocols / Clinical trials / Female / Hospitals / Humans / Male / Metastasis / Middle Aged / Multicenter Studies as Topic / Neoplasm Staging / Neoplasms, Glandular and Epithelial - pathology / Neoplasms, Glandular and Epithelial - surgery / Oncology / Patients / Prospective Studies / Protocol / Pulmonary arteries / Quality of life / Randomized Controlled Trial / Randomized Controlled Trials as Topic / Robotic surgery / Robotic Surgical Procedures - methods / Surgeons / Thoracic surgery / Thoracic Surgery, Video-Assisted - methods / Thymectomy - methods / Thymus gland / Thymus Neoplasms - pathology / Thymus Neoplasms - surgery / Treatment Outcome / Tumors / Veins & arteries