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【评论】一项比较右半结肠癌全结肠系膜切除术与传统手术的Ⅲ期随机临床试验--意大利肿瘤外科协会结直肠癌网络的国内多中心研究(CoME-in试验)的中期分析 被引量:1

A randomized phaseⅢtrial of complete mesocolic excision compared with conventional surgery for right colon cancer:interim analysis of a nationwide multicenter study of the Italian Society of Surgical Oncology Colorectal Cancer Network(CoME-in trial)
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摘要 背景虽然全结肠系膜切除术(complete mesocolic excision,CME)被认为与获得更彻底的淋巴结清扫效果、降低局部复发率及改善患者的生存情况相关,但是由于上述结论的支持证据等级较低且缺乏随机对照临床试验的结果支持,目前关于CME的实施仍存在一定的争议。方法这是一项多中心、随机、优效性临床试验(NCT04871399)。该临床试验的主要研究终点为3年无病生存情况;次要研究终点包括安全性(手术时间、围术期并发症、住院时间),肿瘤相关临床转归(淋巴结清扫数量、3年与5年的总生存情况、5年无病生存情况)与手术质量评估指标(手术标本长度、切除系膜的面积及完整度、切除的回结肠及中结肠血管长度)。该临床试验要求在进行中期分析时需要满足CME组获得更多淋巴结清扫数量的条件。结果本篇报道介绍了该临床试验的中期分析结果。该临床试验纳入了来自9个不同的医疗转诊中心的258例患者。CME组的淋巴结清扫数量多于传统手术组(25枚vs.20枚,P=0.012)。两组在术中和术后并发症、术后死亡率及手术时间方面的情况相近。CME组的住院时间更短(P=0.039)。CME组的手术质量评估指标结果优于传统手术组。生存数据暂未可用。结论中期分析结果显示,在医疗转诊中心开展右半结肠癌CME是安全可行的,并且不会增加围术期并发症。这些结果提供了CME可带来更高的手术质量及更彻底的淋巴结清扫效果的支持证据,对于后续继续招募患者并开展理想的比较研究具有重要的意义。 Background Although complete mesocolic excision(CME)is supposed to be associated with a higher lymph node(LN)yield,decreased local recurrence,and survival improvement,its implementation currently is debated because the evidence level of these data is rather low and still not supported by randomized controlled trials.Method This is a multicenter,randomized,superiority trial(NCT04871399).The 3-year disease-free survival(DFS)was the primary end point of the study.The secondary end points were safety(duration of operation,perioperative complications,hospital length of stay),oncologic outcomes(number of LNs retrieved,3-and 5-year overall survival,5-year DFS),and surgery quality(specimen length,area and integrity rate of mesentery,length of ileocolic and middle-colic vessels).The trial design required the LN yield to be higher in the CME group at interim analysis.Results Interim data analysis is presented in this report.The study enrolled 258 patients in nine referral centers.The number of LNs retrieved was significantly higher after CME(25 vs.20;p=0.012).No differences were observed with respect to intra-or post-operative complications,postoperative mortality,or duration of surgery.The hospital stay was even shorter after CME(p=0.039).Quality of surgery indicators were higher in the CME arm of the study.Survival data still were not available.Conclusions Interim data show that CME for right colon cancer in referral centers is safe and feasible and does not increase perioperative complications.The study documented with evidence that quality of surgery and LN yield are higher after CME,and this is essential for continuation of patient recruitment and implementation of an optimal comparison.
作者 吴妙卿 Wu Miaoqing
出处 《结直肠肛门外科》 2024年第1期95-97,共3页 Journal of Colorectal & Anal Surgery
关键词 全结肠系膜切除术 右半结肠癌 右半结肠切除术 基于胚胎层面的解剖 中央血管结扎 淋巴结切除术 随机对照试验 Complete mesocolic excision Right colon cancer Right hemicolectomy Embryological plane dissection Central vascular ligation Lymphadenectomy Randomized controlled trial
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