对同步双侧肺结节进行一阶段与两阶段视频辅助胸部手术:单中心非随机临床试验 (OTVATS-1) 的协议
Yu Han1, Weixun Zhang1, Peihang Xu1
1Department of General Thoracic Surgery, China-Japan Friendship Hospital, Beijing, China.
BMC surgery
|January 28, 2025
概括
这项前性研究比较了双边肺结节的一阶段和两阶段视频辅助胸部手术 (VATS). 它的目的是为这些手术提供关键的前性数据,以了解这些手术的生存和手术结果.
科学领域:
- 胸部外科手术 胸部外科手术
- 手术瘤学手术瘤学
- 肺部医学 肺部医学
背景情况:
- 回顾性研究表明,一阶段和两阶段的视频辅助胸部手术 (VATS) 对双边肺结节是安全的.
- 目前,将这些方法进行比较的前性数据有限.
研究的目的:
- 为了前性地比较同步双边肺结节的单阶段和双阶段VATS的预后和术后结果.
- 建立基于证据的指导方针,用于双边肺结节的外科治疗.
主要方法:
- 预期的临床试验,在一个机构5年内招募198名患者.
- 主要终点:5年总体存活率. 二级终点包括无病生存率,并发症率,死亡率,疼痛,手术指标和生活质量.
主要成果:
- 该部分将在研究完成后填写.
结论:
- 这项研究代表了第一个前性注册临床试验,对同步双边非小细胞肺癌的一阶段和两阶段VATS进行比较.
- 这些发现将为双边肺结节患者的手术决策提供信息.
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