结直肠肛门外科2024,Vol.30Issue(3) :366-367,369.DOI:10.19668/j.cnki.issn1674-0491.2024.03.023

[评论]关于手术质量评价的探讨:基于腹腔镜改良完整结肠系膜切除术治疗非转移性右半结肠癌的肿瘤学结局的前瞻性研究(PIONEER研究)

Surgical quality assessment for the prospective study of oncologic outcomes after laparoscopic modified complete mesocolic excision for nonmetastatic right colon cancer(PIONEER study)

YANG S Y KIM M J KYE B H 陈北峰 孙凌宇
结直肠肛门外科2024,Vol.30Issue(3) :366-367,369.DOI:10.19668/j.cnki.issn1674-0491.2024.03.023

[评论]关于手术质量评价的探讨:基于腹腔镜改良完整结肠系膜切除术治疗非转移性右半结肠癌的肿瘤学结局的前瞻性研究(PIONEER研究)

Surgical quality assessment for the prospective study of oncologic outcomes after laparoscopic modified complete mesocolic excision for nonmetastatic right colon cancer(PIONEER study)

YANG S Y KIM M J KYE B H 陈北峰 1孙凌宇2
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作者信息

  • 1. 内蒙古赤峰松山医院肛肠科 内蒙古赤峰 024005
  • 2. 哈尔滨医科大学附属第四医院肿瘤外科 黑龙江哈尔滨 150000
  • 折叠

摘要

背景 用于治疗右半结肠癌的改良完整结肠系膜切除术是在原有完整结肠系膜切除方法基础上形成的个体化治疗策略.基于右半结肠癌患者手术标本质量的客观评价结果来评价腹腔镜改良完整结肠系膜切除术的安全性和可行性的研究数量是有限的.PIONEER研究旨在评价腹腔镜改良完整结肠系膜切除术治疗后的肿瘤学结局,同时根据经验丰富的腹腔镜外科医师所施行手术的短期疗效来确定标准腹腔镜右半结肠癌手术的优选的临床相关研究终点及其参考数值.材料和方法 这是一项正在进行中的前瞻性、多中心、单臂研究.本研究在韩国的5个三级结直肠癌诊疗中心进行,纳入250例计划进行腹腔镜改良完整结肠系膜切除术的右半结肠腺癌患者(病灶部位:阑尾至近侧半段横结肠).主要研究终点为3年无病生存情况,次要研究终点包括3年总生存情况、术后4周内的并发症发生率、改良完整结肠系膜切除术的完整性、中央区域手术的彻底性和转移性淋巴结的分布.生存数据将在随访完成(2024年6月)之后可用.结果 术后并发症的发生率为12.9%,其中严重并发症的发生率为2.5%.87%的患者在肠系膜上静脉完全显露或超出肠系膜上静脉所在位置完全显露的条件下完成了彻底的中央区域手术.基于术中照片的评估结果得出75.9%的患者实现了完整结肠系膜平面切除.转移性淋巴结的分布因肿瘤位置和肿瘤分期而异.对术后并发症发生风险低的患者的临床资料进行分析,确定了7个优选的临床相关研究终点,包括总体术后并发症、严重并发症、切除的肠系膜的面积、手术标本质量(完整结肠系膜)、淋巴结检出数目、径向切缘<1mm、中央区域手术的彻底性.结论腹腔镜改良完整结肠系膜切除术治疗右半结肠癌的术后短期疗效良好.本研究确定的优选的临床相关研究终点及其参考数值可作为评价该术式疗效的参考依据.

Abstract

Background The modified complete mesocolic excision(mCME)procedure for right-sided colon cancer is a tailored approach based on the original complete mesocolic excision(CME)methodology.Limited studies evaluated the safety and feasibility of laparoscopic mCME using objective surgical quality assessments in patients with right colon can-cer.The objectives of the PIONEER study were to evaluate oncologic outcomes after laparoscopic mCME and to identify optimal clinically relevant endpoints and values for standardizing laparoscopic right colon cancer surgery based on short-term outcomes of procedures performed by expert laparoscopic surgeons.Materials and methods This is an ongoing pro-spective,multi-institutional,single-arm study conducted at five tertiary colorectal cancer centers in South Korea.Study reg-istrants included 250 patients scheduled for laparoscopic mCME with right-sided colon adenocarcinoma(from the appen-dix to the proximal half of the transverse colon).The primary endpoint was 3-year disease-free survival.Secondary out-comes included 3-year overall survival,incidence of morbidity in the first 4 weeks postoperatively,completeness of mCME,central radicality,and distribution of metastatic lymph nodes.Survival data will be available after the final follow-up date(June 2024).Results The postoperative complication rate was 12.9%,with a major complication rate of 2.7%.In 87%of patients,central radicality was achieved with dissection at or beyond the level of complete exposure of the su-perior mesenteric vein.Mesocolic plane resection with an intact mesocolon was achieved in 75.9%of patients,as as-sessed through photographs.Metastatic lymph node distribution varied by tumor location and extent.Seven optimal clini-cally relevant endpoints and values were identified based on the analysis of complications in low-risk patients.Conclu-sions Laparoscopic mCME for right-sided colon cancer produced favorable short-term postoperative outcomes.The identi-fied optimal clinically relevant endpoints and values can serve as a reference for evaluating surgical performance of this procedure.

关键词

改良完整结肠系膜切除术/右半结肠癌/短期疗效/标准手术

Key words

modified complete mesocolic excision/right-sided colon cancer/short-term outcomes/standardized surgery

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出版年

2024
结直肠肛门外科
广西医科大学

结直肠肛门外科

CSTPCD
影响因子:0.957
ISSN:1674-0491
参考文献量1
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