结直肠癌病人影像学检查临床适用性评价指南(2021版)
通信作者:张忠涛教授
通信作者:王振常教授
【引用本文】中华医学会外科学分会结直肠外科学组,北京市医学影像质量控制和改进中心. 结直肠癌病人影像学检查临床适用性评价指南(2021版)[J]. 中国实用外科杂志,2021,41(10):1104-1110.
结直肠癌病人影像学检查临床适用性
评价指南(2021版)
中华医学会外科学分会结直肠外科学组
北京市医学影像质量控制和改进中心
中国实用外科杂志,2021,41(10):1104-1110
通信作者:张忠涛,E-mail:zhangzht@ccmu.edu.cn;王振常,E-mail:cjr.wzhch@vip.163.com
1 方法
本指南根据美国癌症联合委员会(American Joint Committee on Cancer,AJCC)第8版癌症分期系统,除了对“原发肿瘤T-区域淋巴结N-远处转移M”的TNM基本癌症分期进行评价外,还对基于TNM分期系统衍生的诸多“解剖学”风险因素和疗效预测因素[如环周切缘(circumferential resection margin,CRM)、直肠癌的壁外血管侵犯(extramural venous invasion,EMVI)等]展开评估。临床分期需要在TNM分期前冠以“c”(clinical),病理分期冠以“p”(pathological),接受新辅助治疗后分期冠以“y”(yielding),复发肿瘤冠以“r”(recurrent)[3]。 本指南适用于从事结直肠癌诊治相关的临床医生和研究人员,计划目标人群为怀疑或确诊为结直肠癌的病人。
通过编审委员会中影像医学与核医学、普通外科学、肿瘤外科学、临床流行病学专家合作,开展如下工作:(1)明确结直肠癌诊疗的临床需求。(2)确定文献检索策略并检索。(3)应用美国放射学会使用的推荐分级的评估、制定与评价(Grading of Recommendations Assessment,Development and Evaluation,GRADE)方法评价证据质量,等级A~D代表研究质量由高到低(表1)。(4)根据文献开展影像学检查的临床适用性评价[4]。(5)借鉴国际实践指南报告规范(reporting items for practice guidelines in healthcare,RIGHT)撰写指南[5-6]。
本指南在国际实践指南注册平台注册(注册号为IPGRP-2021CN175)。
检索实施时间:2021-07-05;检索时间范围:1985-01-01至2021-06-30。检索语种:中文,英文。
中文数据库:万方数据库、中国知网数据库、中国生物医学文献数据库。
英文数据库:PubMed、Ovid MEDLINE Epub Ahead of Print、In-Process & Other Non-Indexed Citations、Ovid MEDLINE Daily and Ovid MEDLINE(1946 to Present)。
检索主题词:CT(computed tomography);磁共振成像(magnetic resonance imaging,MRI);检查(examination);影像学(radiology);核医学(nuclear medicine);正电子发射型计算机断层显像(positron emission tomography-computer tomography,PET-CT);超声(ultrasound);直肠腔内超声(endorectal ultrasonography,ERUS);内镜超声(endoscopic ultrasonography,EUS);结肠癌(colon cancer);直肠癌(rectal cancer);结直肠癌(colorectal cancer);分期(staging);淋巴结(lymph node);转移瘤(metastasis);肝(liver);卵巢(ovary);库肯勃瘤(Krukenberg tumor);腹膜(peritoneum);肺(lung);骨骼(bone);并发症(complication);吻合口(anastomosis);漏(leak);梗阻(obstruction)。
检索限定试验对象为人,排除动物试验。排除个案报道、专题笔谈、专家笔谈、讲座。最终写入与本指南密切相关文献共计50篇(参考文献[7]-[56]),并评价证据质量。
2 证据汇总与推荐意见
本指南凝练了结直肠癌诊疗关注的4个常见临床需求,对不同临床需求中涉及的影像学检查开展临床适用性评价,总结如下。 临床需求1:结直肠癌手术前评估
直肠癌首诊治疗前分期:直肠MRI(也有称盆腔MRI,均强调“高分辨成像”;下同)是首选检查方法[7-8](A,A),肿瘤分期诊断准确率为67%~83%[9](A)。良恶性淋巴结判断的敏感度为36%~50%,特异度为95%~100%[10](C)。MRI可较为准确地判断CRM状态[11](A),预测病理学CRM的特异度为92%[12](D);可较准确的判断EMVI,病理结果符合率为80%[13-14](C,B)。对于远处转移瘤的筛查,需选用胸部CT平扫联合腹盆部CT平扫+增强检查[7-8](A,A)。
ERUS和EUS能显示直肠壁分层,有助于评估中下段早期直肠癌肠壁内的肿瘤侵袭深度,诊断浸润深度的准确率为64%~96%[15-17](A,A,B),为内镜黏膜切除术(endoscopic mucosal resection,EMR)、内镜黏膜下剥离术(endoscopic submucosal dissection,ESD)以及肠壁全层切除等手术规划提供支持。诊断淋巴结转移的敏感度为73.2%(95%CI 70.6-75.6)、特异度为75.8%(95%CI 73.5-78.0)(A),但难以检测到较小或距离肿瘤较远的淋巴结,对盆壁淋巴结的诊断能力有限[18]。受探测范围的影响,ERUS对中上段直肠癌的诊断能力有限,ERUS和EUS均无法用于肠梗阻病人。
对于直肠癌病灶局部评估,腹盆部CT平扫+增强检查仅用于MRI检查禁忌的病人[7](A),其判断肿瘤T分期的准确率仅为33%~87%[19-20](C,C),判断淋巴结转移N分期的准确率为35%[19](C),CRM判断的敏感度为43.3%~46.7%[21](B)。
18F-氟代脱氧葡萄糖-正电子发射计算机体层成像(18F-FDG PET-CT)对T分期的判断几乎完全依赖于CT[22](A),不推荐用于结直肠癌的局部病灶浸润深度、CRM、EMVI的评估[23-24](A,C)。但可用于复发性病灶的检出与评估,敏感度、特异度均为91%[25](A)。
直肠癌新辅助治疗效果评估:首选直肠高分辨率MRI,建议增强检查,可有效评估肿瘤缓解程度,预测准确率为86.8%[26](B),治疗后病理T分期(ypT)、病理N分期(ypN)、CRM判断的准确率分别为34%、68%、85%,而CT平扫+增强检查分别为37%、62%、71%,ERUS判断ypT、ypN的准确率分别为27%、65%[27](C)。一项纳入181例病人的研究表明,18F-FDG PET-CT预测病理完全缓解的敏感度、特异度、阳性预测值、阴性预测值及准确率分别为73.1%、64.5%、25.7%、93.5%、65.7%,MRI分别为38.5%、58.1%、13.3%、84.9%、55.2%[28](C)。尚缺乏基于ERUS和CT判断新辅助治疗效果的相关研究。18F-FDG PET-MRI对ypT、ypN判断的准确率均为92%[29](C),但设备普及率很低。见表2。
结肠癌首诊治疗前分期:首选腹盆部CT平扫+增强检查,其判断T分期、N分期的准确率分别为81%、59%~71%[30-32](D,D,D),也用于复发病灶的评估。CT结肠造影检查(CT colonography,CTC)有利于检出结肠病灶[33](B),是肠镜无法开展情况下的首选替代方案[33](A),其禁忌证是临床怀疑或诊断肠梗阻。远处转移瘤的筛查首选胸部CT平扫联合腹盆部CT平扫+增强检查[7-8](A,A)。
MRI平扫+增强检查可作为补充[35](A),检查前需进行充分的肠道准备并注射胃肠动力抑制剂。该方法判断T3、T4肿瘤分期的敏感度为72%~91%,特异度为84%~89%,判断浆膜受累的敏感度为68%~88%,特异度为64%~74%;判断EMVI的敏感度为88%~100%,特异度为62%~70%;判断N分期的敏感度为47%~68%,特异度为64%~86%[36](D)。MRI平扫检查对于T分期、N分期、EMVI判断准确率分别为90%~93%、69%~72%、78%~82%[37](D),但一般不作为首选推荐。
EUS的T分期效能较高,各期肿瘤的T分期敏感度、特异度分别为:T1期,90%、98%;T2期,67%、96%;T3~T4期,97%、83%;N分期的敏感度、特异度分别为59%、78%[38](A)。
有关18F-FDG PET-CT用于评估结肠癌的相关内容,基本与直肠癌相同。
结肠癌新辅助治疗效果评估:建议腹盆部CT平扫+增强检查,T分期及N分期的准确率分别为62%和87%[39](D)。尚缺乏基于MRI和EUS的相关研究。见表3。
临床需求2:结直肠癌手术后随访
胸腹盆部CT平扫+增强检查覆盖范围大、速度快,是结直肠癌术后随访的首选检查方法。对于直肠癌术后病人,还需直肠MRI平扫+增强检查。碘对比剂禁忌的病人可使用腹部+盆部MRI增强联合胸部CT平扫检查,需注意腹盆部检查范围的全覆盖[7-8,11,40](A,A,A,A)。见表4。不同部位转移瘤针对性评估详见临床需求3及表5。
临床需求3:结直肠癌转移瘤针对性评估
不同检查方法评估不同部位的转移瘤的效能存在差异。如发现或高度怀疑转移瘤,建议进行针对性评估。
肝转移:肝脏MRI平扫+增强诊断肝转移的敏感度、特异度分别为81.1%、97.2%[41](A),是确诊肝转移瘤的首选检查方法,在手术切除策略制定等临床决策中发挥重要作用[7,42-43](A,A,C)。应用肝细胞特异性对比剂可增加小病灶的检出能力,敏感度85%[44](A)。CT增强检查诊断肝转移瘤敏感度约80%[44](A),但对小病灶(直径≤1 cm)诊断的敏感度仅约为50%,肝脂肪变性或纤维化背景会增加检出难度[45](A),适用于MRI禁忌的病人。
肝脏超声常用于筛查,发现肝转移瘤的敏感度、特异度分别为63.0%、97.6%[41](A),一般不作为转移瘤的确诊方法。对于CT、MRI难以定性病灶,可使用肝脏超声造影(增强超声),诊断准确率为60%~70%[46](D);尽管术中超声造影诊断肝转移瘤准确率可达97%[47](B),但技术普及程度低。
18F-FDG PET-CT价格贵、普及程度低,在临床怀疑转移但其他影像检查无法确诊、或重大治疗决策前,可作为补充手段,其肝转移性病灶评估的敏感度、特异度分别为91%、76%[25](A),新辅助治疗后准确度降至63%[48](D)。对于直径≤1 cm转移瘤或黏液腺癌肝转移,该检查未显示出明显优势。
肝外转移(肺、非区域淋巴结、卵巢、腹膜、腹腔、骨、脑等):胸部CT平扫即可有效检出肺转移瘤。胸部CT平扫联合腹盆部CT平扫+增强检查是目前检出与评估非区域淋巴结、卵巢、腹膜、腹腔转移瘤的首选检查方法[49](B)。MRI对淋巴结的检出敏感度更高,但MRI、CT均存在难以确定淋巴结性质的问题[50-51](D,A)。骨窗观察胸+全腹CT检查图像可作为骨转移瘤的筛查手段,对于发现可疑病灶或者出现骨痛症状需要明确有无骨转移的高危病人,建议行核素骨扫描进行“一站式”全身骨骼系统评估。脑转移相对少见,临床怀疑时推荐首选颅脑MRI平扫+增强检查,CT平扫或增强仅对较大转移瘤评估有一定价值。18F-FDG PET-CT可作为补充。不建议超声检查。
对于随访频率及非影像学随访内容,详见相关指南[7-8,11,40](A,A,A,A)。见表5。
临床需求4:结直肠癌术后肠梗阻、吻合口漏的诊断
肠梗阻:临床常用腹盆部CT平扫(+增强),增强后有助于判断肠壁血运的状况。腹部平片仅可定性诊断,不作为首选推荐。一般不用腹部MRI检查。肿瘤复发导致的肠梗阻见临床需求1。
吻合口漏:采用水溶性对比剂灌肠后行腹盆部CT检查(A),敏感度、特异度、阳性预测值、阴性预测值为82%、100%、100%、89%,准确率为92%[52](C)。CT平扫+增强检查判断的敏感度为14.8%~57.0%[53-55](D,D,D)。CT平扫临床常用,可观察吻合口周围积气、包裹性积液,但上述征象不具诊断特异性。
超声较难准确判断肠梗阻、吻合口漏的位置与程度,可用于积液的诊断与随访。见表6。
特殊亚组人群考虑 对于检查禁忌的病人,建议谨慎选择检查项目。
病人意愿和价值观考虑 建议医生与病人共同探讨检查的风险及获益。面对术后吻合口漏等亟需临床处理的问题,则以医生的临床技能与经验为主要依据。
有利和不利因素估计 有利因素:将促进临床医生更为合理地选择影像学检查方法。不利因素:语言为中文,限制了在非汉语国家的使用。需根据应用情况进行必要调整。
局限性和不足 适用性评价借鉴了临床医生经验,考虑了临床应用习惯,可能产生偏倚;未进行病人意愿和价值观调查;没有考虑非影像学检查方法。
实施、传播和更新 未来预期进一步开展指南实施效果的评价工作。成果可加入临床辅助决策支持系统。预计2025年前进行必要的修订和更新。
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