A prospective, multicenter, randomized controlled trial (CLASS-01) of laparoscopic versus open surgery for locally advanced distal gastric cancer provides high-level evidence-based evidence for minimally invasive surgery for locally advanced gastric cancer. The findings showed that the experienced surgeons could perform laparoscopic D2 distal gastrectomy for locally advanced gastric cancer safely and effectively, with significant minimally invasive advantages, which attracting extensive attention in the academic community. In order to correctly understand and scientifically apply the results of this research in clinical practice, this paper summarized the research
consensus of CLASS-01 trail for readers, including relevant definitions, surgical indications, device preparation, perioperative management, surgical principles and standards as well as the operational processes and quality control. The relevant standard procedures in this paper are the consensuses which were reached between the researchers when writing the CLASS-01 research plan. The basic principles referred to the international and domestic treatment
guidelines and at the same time fully considered the actual situation of laparoscopic gastric cancer surgery in China. It has crucial guiding significance for the scientific development and rational promotion of laparoscopic surgery for gastric cancer in China.
腹腔镜对比开腹手术治疗局部进展期远端胃癌的前瞻性、多中心、随机对照研究(CLASS-01),为局部进展期胃癌微创外科提供了高级别循证医学证据。结果表明,经验丰富的团队实施腹腔镜远端胃癌D(2)根治术治疗局部进展期患者是安全、有效的,具有显著的微创优势。这一研究成果引起了学术界的广泛关注。为了在临床实践中正确地认识和科学地应用该研究的成果,本文发布CLASS-01研究共识,以飨读者。内容包括相关定义、手术适应证、器械准备、围手术期处理、手术原则与标准操作流程以及质量控制等关键问题。相关标准操作流程是CLASS-01研究方案撰写时,研究者之间达成的共识,其中的基本原则参考了国际国内权威指南,也充分考虑了我国腹腔镜胃癌外科的实际状况,对我国局部进展期胃癌腹腔镜外科技术的科学发展与合理推广,具有重要的指导意义。.