早期胃癌行腹腔镜和开腹全胃切除术RCT研究(CLASS-02)进展

胃癌腹腔镜和开腹根治性全胃切除术安全性的多中心、随机、对照临床研究(CLASS-02)是中国腹腔镜胃肠外科研究组(CLASS)成立后的第2个系列研究,目前已基本完成入组和数据核查工作,预计2019年6月将完成数据分析。CLASS-02研究设计及实施过程中对医学伦理学、入组病例基线评估、消化道重建方式、并发症记录、严重不良事件预案、随访、数据管理等方面问题进行了严格的质量控制。CLASS-02研究完成入组将为后续的腹腔镜全胃切除术的有效性Ⅲ期临床研究(CLASS-02.2)奠定基础。CLASS系列研究将助力中国高质量临床研究数据的发布和外科技术创新。

Progress of CLASS-02 trial of laparoscopic and open total gastrectomy for early gastric cancer

Progress of CLASS-02 trial of laparoscopic and open total gastrectomy for early gastric cancer　　SUN Yi-hong. Department of General Surgery, Institute of General Surgery,Zhongshan Hospital of Fudan University, Shanghai 200032, China
Corresponding author: SUN Yi-hong, E-mail: sun.yihong@zs-hospital.sh.cn
Abstract　CLASS-02 was the second study since the establishment of Chinese Laparoscopic Gastrointestinal Surgery Study Group (CLASS). Till now, the enrollment and data verification had been nearly completed, and it was expected to finish the data analysis in June 2019. Under strict quality control, each of the process included medical ethics, baseline assessment, surgical standardization,evaluation of morbidity, follow-up, and data management was well considered during the study. The results of CLASS-02 study will set a solid foundation for the subsequent phase III clinical trial on efficacy of laparoscopic total gastrectomy. We hope that the CLASS series studies will facilitate the release of high-quality clinical research data and surgical innovation forgastriccancerin China.