BMJ open · 2025
Robot-assisted versus video-assisted thoracoscopic thymectomy for stage I-II thymic epithelial tumour: a protocol for the first multicentre, randomised controlled clinical trial.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод в очереди
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Wang Shuai, Zhu Junkan, Sun Zhenguo, Jiang Jiahao, Wu Bin, Liang Fei, Zheng Yuansheng, Yang Xinyu, Jiang Xifei, Ao Yong-Qiang, Gao Jian, Tan Lijie, Qi Yu, Yue Weiming, Ding Jianyong
Аннотация
BACKGROUND: Minimally 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 ANALYSIS: This 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 DISSEMINATION: The 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 NUMBER: NCT06654830.
METHODS AND ANALYSIS: This 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 DISSEMINATION: The 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 NUMBER: NCT06654830.