在局部晚期胃癌患者的3年无病生存期上, laparoscopic与开放的远端胃切除术的影响:CLASS-01随机临床试验
Jiang Yu1, Changming Huang2, Yihong Sun3
1Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, China.
JAMA
|May 29, 2019
概括
laparoscopic远部胃切除术与局部晚期胃癌的开放手术一样有效,显示了类似的3年无病生存率. 这种微创方法在晚期疾病患者中提供了相似的结果.
科学领域:
- 外科瘤学
- 胃肠道手术
- 最少的入侵性手术
背景情况:
- laparoscopic 远距离胃切除术用于早期的胃癌.
- 对于局部发达的胃癌,腹腔镜远部胃切除术的有效性尚不清楚.
研究的目的:
- 在局部晚期胃癌中比较腹腔镜和开放的远部胃切除术之间的3年无病生存期.
- 作为次要结果,评估整体存活率和复发率.
主要方法:
- 一项随机临床试验,涉及1056名局部晚期胃癌患者 (T2- T4a阶段).
- 患者被随机分为腹腔镜隔离胃切除术 (n=528) 或D2淋巴切除术的开放隔离胃切除术 (n=528).
- 主要终点是3年无病生存期,腹腔镜方法的非劣势率为-10%.
主要成果:
- 腹腔镜术的三年无病生存率为76. 5%,开放胃切除术的77. 8% (绝对差异为-1. 3%,没有超过非劣势率).
- 在3年总生存率 (83. 1% vs. 85. 2%) 或复发模式 (18. 8% vs.
- 这项研究实现了无病生存的主要非劣势终点.
结论:
- 在局部晚期胃癌的3年无病生存期方面, laparoscopic远端胃切除术与开放的远端胃切除术不相差.
- 这些发现支持腹腔镜远部胃切除术作为这种患者群体开放手术的可行替代方案.
- 进一步的研究可能会探讨长期的瘤结果和生活质量.
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