【DCR专区|临床实践指南】美国结直肠外科医师学会结肠癌诊疗临床实践指南（上篇）

原创中华胃肠外科杂志中华胃肠外科杂志

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DCR专区

【DCR专区】为《中华胃肠外科杂志》与Diseases of the Colon & Rectum杂志合作开辟的新专栏，每个月与美国官网同步上线DCR杂志最新文章的中文翻译。

美国结直肠外科医师协会（ASCRS）致力于促进结直肠肛门疾病的科学化预防和管理，以确保为患者提供高质量的诊疗服务。临床实践指南委员会由结直肠外科领域的专业人士组成，旨在领导为结直肠肛门相关疾病定义优质医疗的国际性努力，并根据可获得的最佳证据制定临床实践指南。本指南非限制性的提供了可用于临床决策的信息，没有规定具体的治疗形式。本指南旨在为所有的执业医师、医疗工作者和患者提供本专业所需的所有相关治疗信息，但未囊括所有适当的诊疗方法，也没有排除其他合理的旨在获得相同结果的诊疗方法。医生须根据每个患者的具体情况，对任何特定步骤的适当性做出最终判断。

一

问题陈述

据美国癌症协会（American Cancer Society）粗略统计，仅2020年，约有10.5万美国人确诊结肠癌，4.3万人确诊直肠癌，5.32万人死于结直肠癌¹。在美国，结直肠癌仍然是第三大高发癌症，也是癌症相关死亡的第三大常见原因²。约有90%的结直肠癌患者是在50岁或50岁以上确诊的。虽然50岁以上人群的结直肠癌发病率和死亡率不断下降，但50岁以下人群的发病率和死亡率却持续攀升¹。结肠癌的治疗在很大程度上是由患者就诊时的分期决定的，并强调综合策略在诊断、评估和治疗中的重要性。手术是大多数结肠癌患者的主要治疗方法，而化疗是最常用的辅助治疗手段。在国际CONCORD-2研究的美国队列中，局部、区域及远处转移的结肠癌患者的5年净生存率分别为90%、70%和14%。³ 大肠癌筛查、肠道准备、遗传性结肠癌、加速康复路径、治愈性治疗后的监测和生存及血栓栓塞性疾病的预防，均与结肠癌患者的管理相关，但超出了本指南的范围，并已在其他ASCRS的指南中阐述^4–9。

二

方法学

本指南基于2017年发布的结肠癌指南¹⁰。与2017年版相比，本指南新增11项推荐，更新10项推荐，去除2项推荐（表1）。使用PubMed进行文献检索，检索组合包括胃肠病学、影像学、肿瘤学、全科医学和外科学等专业特定期刊主题词（附录1：期刊主题词），及医学主题词表（MeSH）中“结直肠肿物”并加上“期刊文章”或“指南”或“临床对照试验”或“临床试验”或“临床研究”或“荟萃分析”或“多中心研究”或“观察性研究”或“实践指南”或“随机对照试验”或“系统回顾”等搜索限制，附加的搜索限制包括针对人类的研究、英文和成人，时间限于2015年4月8日至2021年4月4日。使用PubMed检索词/短语进行其他特定主题词的搜索：（1）“不完整的结肠镜检查”，（2）“转化和结直肠和肝脏”，都限于英文，期刊文章，日期范围限于2015年8月6日到2021年4月4日，和（3）“Oncotype DX 或 coloprint 或 ColDx 或 ctDNA 或循环肿瘤DNA 和结肠癌”，限于英文，期刊文章，日期范围为2009年1月1日至2021年6月27日。并于2020年12月2日前完Embase数据库检索，检索年份2017年至2020年，排除Medline/PubMed中包括的主题词后筛选241个独特的主题词，并在文献综述的定性综合阶段纳入了10个额外的主题词。通过嵌入的参考文献中确定额外的35个主题词。上述检索总共产生7957条特定引文，由一名专业的医学图书馆员为文献检索提供咨询，然后由作者进行审查，并选择与临床实践指南最相关的引文。在初筛、二级和三级审查后，总共有1904条引文初步纳入临床实践指南（附录2：PRISMA流程图）。与此同时，重点纳入前瞻性试验、荟萃分析、系统回顾和实践指南，高质量证据不足的观察性研究和回顾性研究在通过同行评议后方可纳入。最终，共有327条引文被收录到参考文献列表中。对最终使用的源文献进行方法学质量评估，对证据基础进行检查，并由指南编写委员会制定诊疗指南。每项推荐的最终等级采用GRADE工具确定（表2）¹¹。当证据基础或治疗指南未达成共识时，由委员会主席、副主席和两位指定审阅者的一致意见确定结果。从起草到最终出版，ASCRS临床实践指南委员会的全体成员共同完成本指南。全体临床实践指南委员会对编写委员会提出的全部推荐条目进行逐条审查。初稿由两名特设委员会成员（MRW和GJC）进行了额外的审查和编辑，随后提交ASCRS执行理事会批准，并在Diseases of the Colon and Rectum杂志上进行同行评议。通常，ASCRS临床实践指南每5年更新一次。该指南未接受任何资金资助，且作者宣称本文没有利益冲突。本指南符合研究和指南评价工具AGREE的条目要求。

三

I. 评估和风险评价

1. 应采集癌症特异性病史，包括疾病特异性症状、既往史和家族史，并进行体格检查和围手术期医疗风险评估。应进行常规实验室检查，包括癌胚抗原（CEA）水平。推荐等级：基于中等质量证据的强推荐，1B。

散发性、家族性（即无可识别的种系突变）和遗传性（即Lynch综合征、FAP、MYH相关）结直肠癌类型分别占美国新发结直肠癌的约65%、30%和<5% ¹²。个人和家族史应记录癌前病变和癌症的种类、发病年龄以及受影响的一级和二级亲属的谱系。应询问患者已知的遗传性癌症易感综合征、既往基因检测结果和可能相关的家庭血统/种族¹³。发现提示遗传易感性的患者应转诊进行遗传咨询，因其结果可能影响手术决策。在50岁以下的结肠癌患者中，高达1/3的个体可能携带与结肠癌相关的胚系突变，而这些患者通常没有典型的与遗传性癌症综合征相关的临床病史，因此强推荐所有年轻发病的结肠癌患者进行胚系突变检测¹⁴。关于遗传性结直肠癌患者的管理指南本协会已发表^6,7。与国家综合癌症网络（NCCN）的指南保持一致，所有新发的结肠癌都应进行微卫星不稳定（MSI）或错配修复蛋白（MMR）表达的评估¹⁵。

结肠癌可表现为无症状，或以乏力、便血、腹痛、排便习惯改变及梗阻为首发症状。最近美国的一项单中心回顾性研究报告称，75%以上的结肠癌确诊发生在出现症状之后，与内镜筛查发现的结直肠癌相比，有症状的结直肠癌分期更晚^16,17。2016年德国一项基于人群的研究也报告了类似的结果，近70%的新发结直肠癌都有伴随症状¹⁸。

应评估患者的健康和营养状况，以指导围手术期管理，并确定术前优化的时机。建议询问患者的饮酒和吸烟史，因为这些习惯已被证实可以增加结直肠癌的患病风险和术后并发症的发生风险^19–22。术后早期死亡在结肠癌手术患者中并不常见，但在高龄和ECOG评分≥2的患者中更为普遍^23,24。体弱患者可从多模式术前优化（如预康复）中获益，但其对术后并发症和生存的获益尚未确定^25,26。

体格检查应包括对腹部肿块及手术瘢痕的评估，因其会影响诊治决策。常规的血液实验室检查应包括全血细胞计数、肝功能和生化检查。结肠癌择期手术前应检测癌胚抗原（CEA）水平，以确定判断复发和生存的基线值，并为术后监测提供参考²⁷。一项基于美国国家癌症数据库的超过130,000例患者的多变量分析表明，术前CEA水平是I期-III期结肠癌患者总生存的独立预测因子²⁸。与术前CEA水平正常的患者相比，CEA水平升高的患者死亡危险增加62%。虽然术前CEA水平是独立的预后因素，但其确定预后意义的最佳临界值尚不清楚^29–32。在IV期结直肠癌中，化疗后CEA降低与生存率提高相关³³。

2. 在结肠手术前，应获得浸润性腺癌的组织学证据。应尽可能同时评估全部结肠粘膜的病理状态。推荐等级：基于低质量证据的强推荐，1C。

如有可能，结肠癌的组织学诊断应在择期手术前确认，因为良性病变如憩室炎或炎症性肠病可能在大体上与结肠癌的内镜或影像学表现相似。结肠镜检查是首选的评估方法，因为它提供了治疗同时性息肉的机会。由于采样误差，内镜活检可能无法确诊或与浸润性腺癌的临床表现不一致，此时可在适当的情况下重复内镜活检。如果考虑病变为恶性，但无法得到组织学确诊（例如可能的采样误差），又不能内镜下切除，则需要进行肿瘤学切除。在可行的情况下，建议在手术前对结直肠粘膜进行全面评估，以检测同时性癌，据报道，4%的I-III期散发性结肠癌患者存在同时性癌³⁴。对结直肠粘膜进行全面检查也可以发现30%-50%的患者存在同时性腺瘤^35,36。应常规进行内镜下标记，并记录标记的位置（即肿瘤远端或近端），便于术中定位。

对于结肠镜不能通过的近端结肠癌患者，预计肿瘤切除范围包括整个近端结肠（如，梗阻型远端升结肠癌）时，通常无需在手术前检查近端结肠。另外，对于内镜无法通过的远端结肠癌（如乙状结肠）患者，手术范围不包括近端结肠，CT结肠镜或FDG PET/CT可能会有帮助。CT结肠成像检查同时性进展期肿瘤（即高级别腺瘤、大腺瘤或癌）的准确性很高，敏感性为94%，据报道会影响2%-21%患者的手术计划^37–39。FDG PET/CT也可能足以排除近端结肠同时性病变，其对进展期腺瘤和结肠癌的阴性预测值分别为93%和100%⁴⁰。另外，在切除肿瘤、恢复肠道连续性或结肠造口后，术中结肠镜检查同时性病变是可行和安全的^41–43。对于术前或术中无法进行结肠评估或评估不充分的患者，术后行结肠镜检查也是一种选择⁴⁴。对比剂灌肠造影在检测结肠黏膜病变方面的成功率相对较低，因此一般不推荐使用⁴⁵。

四

II. 结肠癌的分期

3. 推荐采用口服及静脉注射造影剂的胸腹盆增强CT，或胸部CT平扫联合腹部MRI检查。推荐等级：基于中等质量证据的强推荐，1B。

推荐在择期结肠癌手术之前对胸部、腹部和盆腔进行静脉注射和口服含碘造影剂的CT扫描^15,46。术前CT检查可以发现同时性转移，这通常需要改变治疗策略，也可能改变手术计划。虽然胸部CT发现结直肠癌肺转移的成功率很低（6-8%），但它相对于标准胸片的优势，以及可通过动态复查未定性病变并发现恶性进展的能力，支持它在这种情况下的使用^47–50。对于对碘造影剂过敏或有其他禁忌证的患者，建议采用PET/CT或胸部平扫CT结合腹部和盆腔MRI检查^51,52。CT上不明确的肝脏病变一般需要MRI弥散加权成像进一步检查^46,53–56。

4. PET/CT通常不推荐用于结肠癌的常规分期，但可能有利于IV期患者的手术决策。推荐等级：基于中等质量证据的强推荐，1B。

前瞻性研究尚未证实PET/CT在检测结直肠癌肝转移或腹膜转移方面优于标准的静脉造影增强CT ^51,57,58。目前尚不清楚PET/CT在结肠癌肺转移检测中是否优于增强CT ⁵⁹。国家癌症综合网络（NCCN）和欧洲医学肿瘤学会（EMSO）都不推荐在结直肠癌的初始分期中使用PET/CT ^15,46。相反，对于已确诊的考虑进行治愈性切除的转移性结肠癌患者可推荐进行PET/CT检查，因为如果发现未被识别的转移性病变，可能会改变治疗方案。一项对18项研究（包括1000多例结直肠癌肝转移患者）的荟萃分析显示，PET或PET/CT检查导致24%的患者的治疗方案发生改变⁶⁰。PET-CT也可用于评估CT或MRI结果不明确的患者（如腹膜后淋巴结病变）⁵²。

5. 结肠癌通常应根据美国癌症联合会关于原发肿瘤、淋巴结、远处转移的评价系统（AJCC/TNM）进行分期，并应包括手术切除完整性的评估。推荐等级：基于中等质量证据的强推荐，1B。

肿瘤浸润深度、淋巴结转移和远处转移已被证明是结肠癌预后的预测因子。这些特征在美国癌症联合会TNM分期系统中描述（见表3）。目前版本（第8版）扩大了转移性疾病的定义，纳入了腹膜种植的M1c类别，澄清了癌结节（N1c）的定义，并强调了淋巴血管和神经周围浸润、微卫星不稳定（MSI）、肿瘤出芽和KRAS、NRAS和BRAF突变对考虑治疗方案的重要性⁶¹。和之前的版本一样，阳性淋巴结被定义为含有≥0.2mm癌细胞结节的淋巴结。尽管关于“孤立的肿瘤细胞”或区域淋巴结中测量< 0.2 mm的肿瘤细胞团块的预后价值仍存在争议，但这些术语不包括在AJCC/TNM分期系统中^62–64。

除TNM分期外，还应评估肿瘤的组织学分级和手术切除的完整性。组织学分级，特别是细胞分化差，已被证明是预后的预测指标，是一些治疗方案的重要参考因素⁶⁵。根据结直肠癌病理标本处理的AJCC协议，手术切除后有无肿瘤残留被指定用以下术语进行描述：不确定（即切缘无法评估），阴性（即切缘未被浸润性腺癌累及）或阳性（即浸润性腺癌离切缘≤ 1 mm）⁶⁶。

五

III. 原发肿瘤的手术治疗

6. 当治疗计划中不包含新辅助治疗时，应及时进行根治性结肠切除术。推荐等级：基于低质量证据的强推荐，1C。

从结肠癌确诊到进行根治性手术的时间间隔对肿瘤结果的影响尚不清楚。最近一项基于美国国家癌症数据库及监测、流行病学和结果数据库（SEER数据库）的回顾性分析表明，手术延迟3-6周与总生存率降低有关，但同时一项基于加拿大人群的回顾性研究和最近的两项单中心研究表明，手术延迟长达12周对无病生存或总体生存时间没有影响^67-70。虽然无法根据现有数据推荐特定的手术间隔时间，但癌症不治疗会随着时间的推移而进展，因此，在没有必要延迟的情况下应尽快完成手术。同时，接受新辅助治疗患者的手术时机根据其治疗计划的时间表决定。

7. 术中应全面探查，并在手术记录中记录探查结果。推荐等级：基于低质量证据的强推荐，1C。

手术探查包括肉眼所见，开放手术可通过触诊了解腹腔、盆腔器官情况，并检查是否合并其他器官受累或出现远处转移（例如邻近器官受累、腹膜转移）。如果在探查过程中偶然发现腹膜转移，建议进行活检明确诊断，并确定和记录转移的范围和分布，推荐使用腹膜癌评分指数进行评估⁷¹。一般来说，如果没有梗阻或穿孔，需要在完成多学科讨论，并获得患者的知情同意后方可以进行结肠切除和细胞减灭术⁷²。

手术记录应包括术前相关检查和探查结果，包括是否存在同时性转移或肠系膜肿大淋巴结、肿瘤部位和邻近器官受累。还应描述手术中的细节，包括切口类型、粘连的严重程度、肠道意外损伤和修补情况、肠管和肠系膜切除的范围、滋养血管结扎的水平、吻合方法、受累器官的整块切除情况，以及术中包括手术切缘的切除完整性的评估。清单式手术记录已被证明是可以改善手术质量的关键因素，目前已被美国外科医生协会癌症委员会认可和推广。

8. 结肠切除范围应与结肠癌的淋巴引流区域相一致。推荐等级：基于中等质量证据的强推荐，1B。

结肠癌根治性切除的范围取决于原发病灶的部位及其淋巴血管引流的途径。在没有病理证实其他部位有病灶情况下，结肠癌切除范围通常应包括近端和远端5-7cm的纵向肠管，以确保充分切除有转移风险的肠周淋巴结^75-76。此外，应切除肿瘤供应血管对应的肠系膜，以便切除引流的中间和中央组淋巴结^77-78。例如，如果没有发现标准切除范围之外的肿大淋巴结，右侧结肠癌只需从回结肠血管和结肠中动脉的右分支根部离断。乙状结肠癌需要在直肠上动脉和左结肠动脉起始处离断，肠系膜下静脉在胰腺下缘附近离断。同时应保证结肠系膜的完整切除^79-80。由于切除时评估的淋巴结总数与存活率相关，因此淋巴结检查应尽可能充分^81-84。建议至少评估12枚淋巴结才能确定N0分期，检查少于12枚淋巴结是II期结肠癌的高危因素^85,86。如果病理报告中淋巴结检出少于12枚，外科医生应根据美国病理学家学会制定的指南要求对标本进行额外的评估、处理和报告^66,87。

横结肠癌和结肠脾曲癌在肿瘤切除范围及淋巴结清扫术式选择方面需要特别关注。2019年一项对横结肠癌患者的荟萃分析表明，横结肠切除术和扩大的左右结肠切除术的短期和长期疗效相当。2020年，一项来自意大利的研究表明，与扩大切除相比，接受节段性切除的患者术后并发症更少，包括吻合口漏发生率更低（2% vs. 4%，p<0.05），3年无病生存率也显著提高（86% vs.78%，p<0.05）^88,89。2021年，一项基于美国国家癌症数据库针对I–III期横结肠癌的研究发现，扩大切除和节段切除的原始5年生存率相似（40.7% vs. 41.3%，p=0.34），但在调整协变量后，扩大结肠切除与较低的存活率相关（HR，1.07；95% CI，1.04–1.10；p<0.001）⁹⁰。由于报告数据存在不一致性，建议在仔细检查肿瘤及其供血血管、预估切除方式对功能影响的基础上再确定手术切除范围。

结肠脾曲癌通常沿左侧结肠系膜血管蒂发生淋巴结转移^91,92，但有研究发现在肠系膜上动脉及其属支（包括结肠中动脉、结肠右动脉和回结肠动脉）周围也发现阳性淋巴结，且发生率高达9% ⁹³。尽管如此，回顾性研究和荟萃分析仍表明，节段性切除是扩大切除术的合理替代方案^90,94-96。

9. 不推荐常规行扩大淋巴结清扫术。推荐等级：基于中等质量证据的弱推荐，2B。

3%至11%的结肠癌患者会出现标准切除范围外的淋巴结转移（即D3淋巴结转移），且T分期较晚的患者发生的概率更大^97-100。在没有结肠周围或中间淋巴结受累（跳跃性转移）的情况下，中央淋巴结转移的发生率为0-4% ^101,102。扩大淋巴结清扫术，又称为“中央血管结扎术”或“D3切除术”，是指清扫主要供血血管和相关中间淋巴结（D2）近端的淋巴结。这在右半结肠癌手术中体现为沿着肠系膜上动脉和静脉清扫淋巴结，而在乙状结肠癌手术中体现为在肠系膜下动脉起点处清扫淋巴结。相反，术语“完整结肠系膜切除”是强调结肠癌切除标本中结肠系膜封包的完整性，而不是强调血管结扎的特定水平¹⁰³。

虽然扩大淋巴结清扫术已被证明可提高淋巴结检出数量，并可能会改善N分期准确性，但同时也增加术后并发症^97,104-107。最近的观察性研究和荟萃分析表明，扩大淋巴结清扫术与降低癌症复发率和提高无复发生存率有关^108-110。相反，其他研究表明，扩大淋巴结清扫术没有使患者得到生存获益^{104,106,111,112}。鉴于当前文献报道结果的不一致性，仍需进一步的研究才能证明常规扩大淋巴结清扫的必要性。但由于中央/D3淋巴结阳性与无复发生存率降低有关，因此对于标准切除范围之外发现临床阳性或可疑阳性的淋巴结可以进行选择性淋巴结清扫¹¹³。

10. 对于粘连或侵犯邻近器官且可以进行根治性切除的结肠癌，建议进行整块切除以确保切缘阴性。推荐等级：基于中等质量证据的强推荐，1B。

局部肿瘤控制是通过完整切除肿物及周围受累组织来实现的^114-117。结肠癌和周围器官之间的粘连不应离断开，已有研究证明34%-84%的结肠癌患者中的黏连组织内含有恶性肿瘤细胞^114,118,119。最近有三项研究强调结肠癌手术切缘阴性的重要性，其中切缘阳性患者在疾病进展、无病生存期和总生存期方面的结果较差^120-122。术前需组成一个多学科的手术团队，并采用多种诊断方法（例如CT或MRI）评估肿瘤邻近器官的受累情况以协助手术团队制定恰当的手术计划¹²³。对于经验丰富的团队，腹腔镜和机器人手术也可以用于肿瘤及周围受累器官的整块切除^124-129。

11. 与卵巢黏连严重的结肠癌患者，通常推荐行卵巢切除，但不推荐常规预防性卵巢切除。推荐等级：基于低质量证据的强推荐，1C。

对于明显累及卵巢的结肠癌，联合卵巢的整块切除通常应作为根治性切除术的一部分。对于怀疑或已明确有远处转移的患者，在回顾性系列研究中发现联合卵巢切除可带来患者的生存获益¹³⁰。在这种情况下，即使另一侧卵巢大体正常，通常也应行双侧卵巢切除^130-132。数据表明，对于双侧卵巢外观大体正常的患者，在结直肠癌手术时不支持行常规预防性卵巢切除¹³³。然而，对于有卵巢癌遗传基因或者渴望降低风险的绝经期女性，可以进行预防性卵巢切除。在乳腺癌易感基因1或2（BRCA1或BRCA2）携带者中，联合卵巢切除可使卵巢癌、输卵管癌或腹膜癌的患病风险降低80%，死亡率降低77% ¹³⁴。

12. 对于局部进展期结肠癌患者，新辅助化疗或放疗可使肿瘤退缩，有助于达到切缘阴性的肿瘤切除。推荐等级：基于中等质量证据的弱推荐，2B。

新辅助化疗和/或放疗可考虑用于促进局部进展期结肠癌的完整切除^135-139。目前NCCN指南建议对“淋巴结融合或临床T4b”结肠癌患者进行基于奥沙利铂的新辅助化疗。在2020年的一项汇总六项研究的系统评价中指出，新辅助化疗使2/3患者的肿瘤体积缩小，使4%-37%的患者发生病理性肿瘤退缩；与无应答的患者相比，有应答的患者3年无病生存率显著提高（94% vs. 63%，p=0.005）。与辅助化疗相比，接受新辅助化疗的cT4b肿瘤匹配患者的3年死亡率降低了23%（HR 0.77，95% CI 0.6–0.98；p = 0.04），但对cT3及cT4a肿瘤患者没有益处¹⁴⁰。

FOxTROT研究是一项来自英国的前瞻性研究，该研究将1053名cT3-4N0-3M0结肠癌受试者随机分配至以奥沙利铂为基础的辅助化疗组（12个周期）和新辅助治疗组（3个周期），然后进行手术和辅助化疗（9个周期）137。该研究的初步结果以摘要的形式发表，研究表明两组之间在术后并发症发生率及死亡率方面没有差异。接受新辅助化疗的患者具有显著的T和N分期的下降（p<0.001），病理完全缓解率为3.8%，并且在2年内有减少复发的趋势（14.0% vs. 17.5%）¹⁴¹。更长时间随访的完整结果可能证实或改变我们的观点。

PRODIGE 22研究是法国的一项多中心协作研究，104名cT3-4和/或N2的结肠癌患者随机分为两组：一组患者在根治性手术后行辅助化疗（12个周期），另一组患者先行新辅助化疗（4个周期）后再行根治性手术、术后再行辅助化疗（8个周期）^[142]。接受新辅助治疗的受试者出现1-2级肿瘤退缩（44% vs. 8%，p<0.001）的可能性更大，并且pTNM降期率显著增加。但是，两组的3年总生存率（90.3% vs. 90.4%）和3年无病生存率（76.8% vs. 69.2%）无明显差异。该研究的局限性是新辅助治疗（实验）组可能存在过度治疗。

虽然FOxTROT和PRODIGE 22研究均未显示新辅助化疗对患者的生存优势，一项2018年的基于美国国家癌症数据库的回顾性分析发现，与辅助化疗相比，接受新辅助化疗的cT4b结肠癌患者的3年总体生存率具有明显优势（74% vs. 66%，p=0.002）¹⁴³。在倾向评分匹配后，新辅助治疗组中cT4b期患者的总生存期提高了23%（HR 0.77，95% CI 0.60-0.98，p= 0.004），但cT3及cT4a期的患者未发现生存优势。

新辅助放疗并未得到广泛应用，但一项单中心研究和一项美国国家癌症数据库研究均得出结论，cT4期疾病的新辅助放疗可能与肿瘤降期、R0切除率升高和总生存期延长有关138,139。在这些复杂的情况下，建议多学科讨论进行决策。

13. 同时性结肠癌可以通过两次节段性切除或次全结肠切除治疗。推荐等级：基于中等质量证据的强推荐，1B。

同时性结肠癌定义是指诊断结肠癌同时发现另一处原发性结肠癌或12个月内确诊第二个原发性结肠癌¹⁴⁴。据报道，同时性结肠癌发生率在4-5%，并且总体生存率下降^34,145。同一区域的同时性结肠癌可进行节段性结肠切除，而不同区域的同时性结肠癌可以进行扩大切除或两次节段性切除术¹⁴⁶。扩大切除虽然不会增加二次手术的发生率，但是也没有增加生存获益，并且可能会降低术后的生活质量^34,147。

当结肠癌合并其他结肠疾病（如慢性溃疡性结肠炎或遗传性非息肉病性结直肠癌综合征）时，切除的范围应重新考虑。这些情况超出了本临床实践指南的范围，并在相关临床实践指南中进行讨论。

14. 当专业技术成熟时，微创结肠切除术是择期结肠癌手术的首选。推荐等级：基于高质量证据的强推荐，1A。

结肠癌手术的微创手术（minimally invasive surgery，MIS）方法包括多孔、单孔、手辅助腹腔镜和机器人技术。尽管由于各种因素（例如：肿瘤巨大，邻近器官侵犯），某些病变可能不适合采用微创方法，但在大多数情况下，如果有适当的专业知识和经验，MIS是首选。最重要的是，MIS应达到与开放手术相同的目标；如果不可能达到，建议转为开放手术。在美国和国际上有经验丰富的外科医生参与的几项大型多中心随机试验表明，与开放手术相比，多孔腹腔镜手术治疗局部结肠癌可以缩短住院时间，改善其他短期结局，并具有同等的肿瘤学效果^149-153。尽管在比较腹腔镜和开腹手术治疗结肠癌的前期试验中，横结肠癌患者被排除在外，但最近的非随机数据和荟萃分析表明，即使在这种情况下，腹腔镜技术在肿瘤学效果上仍是等效的，并改善了短期疗效^154-157。

现有的观察性研究和荟萃分析表明，单孔与多孔腹腔镜手术的外科学和肿瘤学结果相同^158-161。另外，两项分别纳入195名和200名患者的随机对照试验对单孔和多孔腹腔镜手术进行比较，结果发现在手术时间、切除淋巴结数量、切缘长度和术后并发症方面没有明显差异^162,163。

手辅助腹腔镜手术（hand-assisted laparoscopic surgery，HALS）与开放及传统腹腔镜右半结肠切除术治疗结肠癌的随机对照试验表明，腹腔镜和HALS技术的短期疗效与开放手术相似，HALS相对于开放手术疼痛更轻，恢复更快，而长期的肿瘤学效果没有差异^164,165。一项机器人与腹腔镜右结肠切除术治疗结肠癌的随机对照试验表明，机器人组在术后并发症发生率和短期癌症相关预后方面没有差异，但增加了手术时间和成本¹⁶⁶。虽然许多报告支持HALS和机器人手术进行右半结肠切除，但对于左结肠切除术仍没有足够的证据进行有意义的推荐。但是，只要按照结肠癌手术的原则进行手术，就可以合理地得出如下结论，左半结肠切除也适用于HALS或机器人。

15. 对于恶性息肉，选择内镜切除或外科手术切除在很大程度上取决于息肉的组织病理学特征和切除的完整性。推荐等级：基于中等质量证据的强推荐，1B。

恶性息肉，尤其是源于腺瘤性息肉的T1期肿瘤⁵⁵，可以通过内镜切除或结肠切除术进行充分的治疗。对于低危恶性结肠息肉，结肠镜息肉切除术、内镜粘膜切除术、内镜粘膜下剥离术或内镜与腹腔镜联合手术均可常规、安全的进行，并成功地避免了结肠切除^167-171。在选择性的患者中，初始治疗尝试内镜下整块切除通常是必要的，这可使>80%的患者达到治愈性切除^172-174。息肉切除术后标本切缘、癌细胞的粘膜下浸润深度、细胞分化程度、淋巴血管和神经周浸润（LVI和PNI）、肿瘤出芽是内镜切除或结肠切除术时需要考虑的组织病理学因素。

息肉切除术后阴性切缘的定义存在争议，早期的报道提出需要≥2mm切缘¹⁷⁵。2012年美国一项单中心研究，对143名行内镜切除后补充结肠切除的恶性息肉患者回顾性分析发现，切缘≥1mm、<1mm及切缘无法判断者，其手术部位癌残留及区域淋巴结阳性率分别为0%、9%、16%和5%、21%和7%¹⁷²。2013年基于英格兰北部NORCCAG（NORthern Colorectal Cancer Audit Group，北方结直肠癌审计组）数据库的分析发现，恶性息肉切缘0mm和>0mm导致手术部位癌残留和区域淋巴结阳性率分别为34%和5% ¹⁷³。2018年苏格兰的一项全国性研究中，息肉切除术后出现手术部位残余肿瘤及区域淋巴结转移的患者均为7%，而不完整的息肉切除，患者手术部位肿瘤残余和区域淋巴结发生转移的比例达到29%和9%。这项苏格兰研究还表明，息肉切除术后阴性切缘≥1mm与切缘≥0mm相比，并没有降低手术后癌残留的风险¹⁷⁴。

粘膜下浸润深度是恶性息肉的重要预后因素。浸润深度可分为浅层、中层、深层（即SM1、SM2、SM3），或根据测量到粘的浸及膜下层的深度（如<500、500-1000或>1000μm）分层^176,177。2013年的一项系统综述表明，SM1、SM2及SM3侵袭与淋巴结转移相关的比例分别为3.4%、8.5%和22.6% ¹⁷⁸。上述引用的其他研究也进一步支持SM3或>1000μm浸润深度的不良预后价值，并支持行外科手术切除。Haggitt分类法也可用于恶性息肉的淋巴结转移风险或相关其他不良结局的分层。1985年Haggitt报道，当恶性侵犯局限于带蒂息肉的头部、颈部及蒂部（即1、2、3级）时，不存在淋巴结转移，101例患者中只有1例（1%）死于结直肠癌。因此，一般认为在没有其他危险因素（如LVI、分化差等）的情况下，完整切除1-3级浸润性带蒂恶性息肉是足够的。另外，在该研究中Haggitt 4级浸润的患者（定义为带蒂或无蒂息肉的基底部粘膜下层见癌细胞），28例中有7例（25%）出现淋巴结或全身转移。随后的研究发现，高达13%的4级恶性息肉患者存在淋巴结转移，这些数据支持对这类患者应进行结肠切除术^179,180。然而，我们现在知道，当恶性息肉被归类为低风险或高风险并考虑内镜或手术切除时，SM深度和Haggitt分级只是众多变量中需要考虑的两个变量。

2013的一项系统回顾和荟萃分析表明，pT1期结直肠癌患者手术切除后淋巴结转移率为11%，LVI、粘膜下浸润≥1mm、低分化癌和肿瘤出芽与淋巴结转移相关性分别为22%、12%、24%和21% ¹⁷⁸。

低风险的带蒂或无蒂的恶性息肉可定义为无LVI和PNI、无或低肿瘤出芽、切缘阴性、粘膜下浸润深度<1mm的高、中分化癌。对于低风险恶性息肉内镜下切除通常被认为是一种确定性治疗方案，因为发生结肠壁癌残留或淋巴结阳性的风险是可以忽略不计的。相反，当无蒂或带蒂的恶性息肉为低分化癌，切除阳性或不确定，或>1mm的粘膜下浸润，节段性肠管切除术通常是非常必要的，因为内镜切除后会出现无法接受的结肠壁或区域淋巴结累及的高复发风险^{171,172,174,181-183}。

六

IV. 结肠癌相关急诊

大约20%的结肠肿瘤患者会因出血、穿孔或梗阻就诊急诊外科¹⁸⁴。此时的治疗目标是：1）避免并发症的直接负面影响（如死亡、败血症）；2）实现最佳的肿瘤控制；3）快速康复，以便根据需要启动适当的全身治疗。

16. 对于可治愈的梗阻性左侧结肠癌患者，应根据患者意愿和当地医疗机构的专业水平，选择内镜支架减压、转流性结肠造口后二期结肠切除术或一期行结肠节段切除术。推荐等级：基于中等质量证据的强推荐，1B。

2020年，一项汇总27项研究，包括近4000名患者（其中大多数为梗阻性左侧结肠癌）的系统回顾和荟萃分析表明，初始进行支架植入可提高一期吻合率，降低并发症发生率和30天死亡率，而且3年及5年的无病生存和总生存期无显著差异¹⁸⁵。2017年的一项汇总8项随机对照试验的荟萃分析显示，在左侧结肠癌患者中将支架作为桥接手段后再手术和急诊手术相比，60天死亡率为9.6%和9.9%（p>0.05），60天并发症发生率为34%和51%（p=0.02），临时造口率为34%和51%（<0.001），一期吻合率70%和54%（p=0.04）¹⁸⁶。此外，在该研究中，急诊手术组永久造口率更高（35% vs. 22%）。尽管如此，对于吻合风险较低或患者和外科医生均可接受临时性回肠转流造口的患者，肠管节段切除术的初始治疗可能也是合适的。

尽管有报道支架置入成功率为77%-81%，其穿孔率为2%-9%。支架植入后穿孔的患者局部区域癌症复发的风险明显增加^187-190。

对于左侧结肠癌梗阻患者，转流性结肠造口可能是支架置入的替代方案。在最近的荷兰的一项基于全国人群的队列研究中，对匹配的梗阻性左侧结肠癌患者进行初始性转流造口和初始内镜支架减压治疗，初始进行转流性造口的患者更有可能进行腹腔镜结肠节段切除术（57% vs. 9%，p= 0.001），一期吻合率更高（88% vs. 41%，p= 0.001），90天死亡率降低（1.7% vs. 7.2%，p=0.03），3年总生存率显著提高（79% vs. 73%，95% CI 0.20-0.65），永久性造口减少（22% vs 42%，p<0.0010）^191,192。

最后，对每位梗阻性左侧结肠癌的患者，都应考虑患者的病情、外科医生的经验、内镜专业水平以及患者意愿，以选择最佳的治疗方案。

17. 对于可治愈的梗阻性右侧结肠癌或横结肠患者，可以进行一期结肠切除术或一期内镜支架减压行二期结肠切除术。推荐等级：基于低质量证据的强推荐，1C。

对于梗阻性右侧或横结肠癌，肠管节段切除联合回结肠吻合在大多数情况下是安全的¹⁹³。此时进行一期吻合取决于患者手术时的一般状态，以及是否存在其他需要进行转流性造口或单腔造口的因素。

虽然大多数评估支架作为桥接手术（stenting as a bridge to surgery，SBTS）的研究集中在左侧结肠梗阻，但最近的回顾性研究表明，选择性的右侧结肠梗阻患者可以安全有效地进行支架植入，87-96%的病例成功放置支架^194,195。在一项基于日本国家数据库的研究中，1500名匹配的急诊行右侧结肠切除或SBTS的患者中，SBTS组使用腹腔镜的比例更高（50% vs. 25%，p<0.001），造口更少（1.7% vs. 5.1%，p<0.001），住院时间更短（13天 vs. 15天，p<0.001）¹⁹⁶。2020年，一项对比急诊结肠切除术和SBTS治疗右侧结肠癌的系统回顾和荟萃分析显示，两组之间的5年无病生存率和总生存率相似¹⁹⁷。

18. 如果结肠穿孔或即将穿孔，推荐在可行的情况下按照肿瘤学原则进行切除，并以更低的阈值考虑分期手术。推荐等级：基于低质量证据的强推荐，1C。

一些回顾性研究比较了穿孔结肠癌和非穿孔结肠癌的预后^190,198,199。总的来说，穿孔患者初次吻合的可能性较小，且术后发病率和死亡率增加。此外，穿孔癌患者的5年无病生存率和总生存率明显较低¹⁹⁸，而异时性腹膜癌病发生率较高200。游离穿孔患者的总生存率比包裹性穿孔的患者低¹⁹⁹。对于梗阻性肿瘤近端未受累者结肠穿孔的病例建议按照通常的肿瘤学原则切除肿瘤。此外，穿孔段应根据标准的手术原则，通过带或不带转流的修复或切除来处理。在污染最小、组织质量健康、临床稳定的患者中，可以考虑吻合术（带或不带近端转流）作为结肠造口的一种选择。另外，对于包裹穿孔或自由穿孔并发脓肿或腹膜炎的患者，应考虑肿瘤切除术和单腔造口术。自扩张的金属支架在穿孔结肠癌的治疗中是禁忌。

19. 如果可行，新诊断的结肠癌引起的急性下消化道出血最初应采用非手术治疗。推荐等级：基于低质量证据的强推荐，1C。

慢性失血引起的贫血在结肠癌患者中很常见，这通常不会改变手术时机和方法。然而，结肠癌引起的急性大量下消化道出血是一种潜在的威胁生命的并发症。在没有已知来源的胃肠道出血的情况下，需要对病人进行复苏，然后尝试定位出血的部位。术前定位的选择包括放射性核素成像、CT血管造影、常规血管造影和结肠镜检查。在各种病理情形引起的胃肠道出血的研究中，CT血管造影优于放射性核素造影（敏感性分别为85%和20%-60%）^202-205。常规血管造影可检测出40%-90%的患者出血，并可联合血管造影栓塞，可使70%-90%的患者出血停止206。紧急结肠镜检查在消化道出血较低的患者中成功率为20%-40%，与血管造影一样，具有诊断和治疗双重优势^206,207。当非手术方法不能控制结肠癌出血时，通常需要手术干预。在这种情况下，在符合既定外科原则的情况下，当肿瘤切除术可以安全实施时，推荐采用肿瘤切除术。

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