完整结肠系膜切除术治疗结肠癌的疗效和安全性：前瞻性、非随机、双盲、对照临床试验的 3 年结果。
Efficacy and Safety of Complete Mesocolic Excision in Patients With Colon Cancer: Three-year Results From a Prospective, Nonrandomized, Double-blind, Controlled Trial.
机构信息
Department of Gastrointestinal Surgery, Peking University People's Hospital, Beijing, China.
Key Laboratory of Colorectal Cancer Diagnosis and Treatment Research, Beijing, China.
出版信息
Ann Surg. 2020 Mar;271(3):519-526. doi: 10.1097/SLA.0000000000003012.
OBJECTIVE
The aim of the study was to evaluate the oncological outcomes of complete mesocolic excision (CME) in colon cancer patients.
SUMMARY BACKGROUND DATA
CME is considered a standard procedure for colon cancer patients. However, previous evidence regarding the effect of CME on prognosis has fundamental limitations that prevent it from being fully accepted.
METHODS
Patients who underwent radical resection for colon cancer were enrolled between November 2012 and March 2016. According to the principles of CME, patients were stratified into 2 groups based on intraoperative surgical fields and specimen photographs. The primary outcome was local recurrence-free survival (LRFS). The clinicopathological data and follow-up information were collected and recorded. The final follow-up date was April 2016. The trial was registered in ClinicalTrials.gov (identifier: NCT01724775).
RESULTS
There were 220 patients in the CME group and 110 patients in the noncomplete mesocolic excision (NCME) group. Baseline characteristics were well balanced. Compared with NCME, CME was associated with a greater number of total lymph nodes (24 vs 20, P = 0.002). Postoperative complications did not differ between the 2 groups. CME had a positive effect on LRFS compared with NCME (100.0% vs 90.2%, log-rank P < 0.001). Mesocolic dissection (100.0% vs 87.9%, log-rank P < 0.001) and nontumor deposits (97.2% vs 91.6%, log-rank P < 0.022) were also associated with improved LRFS.
CONCLUSIONS
Our findings demonstrate that, compared with NCME, CME improves 3-year LRFS without increasing surgical risks.
目的
本研究旨在评估结肠癌患者完整结肠系膜切除术（CME）的肿瘤学结局。
背景资料概要
CME 被认为是结肠癌患者的标准手术程序。然而，之前关于 CME 对预后影响的证据存在根本性的局限性，使其无法被完全接受。
方法
本研究纳入了 2012 年 11 月至 2016 年 3 月期间接受根治性切除术治疗结肠癌的患者。根据 CME 的原则，根据术中手术视野和标本照片将患者分为 2 组。主要结局是无局部复发生存率（LRFS）。收集并记录临床病理数据和随访信息。最终随访日期为 2016 年 4 月。本试验在 ClinicalTrials.gov 注册（标识符：NCT01724775）。
结果
CME 组有 220 例患者，非完整结肠系膜切除术（NCME）组有 110 例患者。基线特征均衡。与 NCME 相比，CME 与更多的总淋巴结数（24 个 vs. 20 个，P=0.002）相关。两组术后并发症无差异。与 NCME 相比，CME 对 LRFS 有积极影响（100.0% vs. 90.2%，对数秩 P<0.001）。结肠系膜切开术（100.0% vs. 87.9%，对数秩 P<0.001）和非肿瘤沉积物（97.2% vs. 91.6%，对数秩 P<0.022）也与改善 LRFS 相关。
结论
与 NCME 相比，CME 可提高结肠癌患者 3 年 LRFS，而不增加手术风险。
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