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全结肠系膜切除术与右半结肠癌传统手术的比较:意大利外科肿瘤学会结直肠癌网络的一项全国多中心研究(CoME-in试验)。一项随机对照试验的研究方案。

Complete mesocolic excision in comparison with conventional surgery for right colon cancer: a nationwide multicenter study of the Italian Society of Surgical Oncology colorectal cancer network (CoME-in trial). Study protocol for a randomized controlled trial.

作者信息

Degiuli Maurizio, Solej Mario, Resendiz Aguilar Hogla Aridai, Marchiori Giulia, Reddavid Rossella

机构信息

University of Turin, Department of Oncology, Surgical Oncology and Digestiver Surgery, San Luigi University Hospital, Orbassano, 10043 Torino, Italy.

出版信息

Jpn J Clin Oncol. 2022 Oct 6;52(10):1232-1241. doi: 10.1093/jjco/hyac116.

Abstract

Complete mesocolic excision with central vascular ligation, or simply CME, includes the sharp dissection along the mesocolic visceral and parietal layers, with the ligation of the main vessels at their origins. To date, there is low evidence on its safety and efficacy. This is a study-protocol of a multicenter, randomized, superiority trial in patients with right-sided colon cancer. It aims to investigate whether the complete mesocolic excision improves the oncological outcomes as compared with conventional right hemicolectomy, without worsening early outcomes. Data on efficacy and safety of complete mesocolic excision are available only from a large trial recruiting eastern patients and from a low-volume single-center western study. No results on survival are still available. For this reason, complete mesocolic excision continues to be a controversial topic in daily practice, particularly in western world. This new nationwide multicenter large-volume trial aims to provide further data on western patients, concerning both postoperative and survival outcomes.

摘要

完整结肠系膜切除术伴中央血管结扎术,简称CME,包括沿结肠系膜脏层和壁层进行锐性分离,并在主要血管起始处进行结扎。迄今为止,关于其安全性和有效性的证据不足。这是一项针对右侧结肠癌患者的多中心、随机、优效性试验的研究方案。其目的是研究与传统右半结肠切除术相比,完整结肠系膜切除术是否能改善肿瘤学结局,且不恶化早期结局。关于完整结肠系膜切除术有效性和安全性的数据仅来自一项招募东方患者的大型试验以及一项低样本量的单中心西方研究。目前仍没有生存结果。因此,完整结肠系膜切除术在日常实践中仍是一个有争议的话题,尤其是在西方世界。这项新的全国性多中心大样本量试验旨在提供更多关于西方患者术后和生存结局的数据。

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