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中华结直肠疾病电子杂志 ›› 2026, Vol. 15 ›› Issue (04) : 289 -298. doi: 10.3877/cma.j.issn.2095-3224.2026.04.001

指南与共识

结直肠癌人工智能应用场景评测专家共识(2026版)
中华医学会外科学分会结直肠外科学组, 中国抗癌协会大肠癌专业委员会, 中国医师协会外科医师分会结直肠外科医师专家组   
  1. 1. 首都医科大学附属北京友谊医院普通外科中心,北京 100050
    2. 国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院结直肠外科,北京 100021
    3. 中山大学附属第六医院普通外科(结直肠外科),广州 510655
  • 收稿日期:2026-06-12 出版日期:2026-08-25
  • 基金资助:
    国家自然科学基金项目(U25C2037)

Expert consensus on evaluation standards for artificial intelligence applications in colorectal cancer (2026 edition)

Colorectal Surgery Group, Chinese Society of Surgery, Chinese Medical Association, Colorectal Cancer Committee, China Anti-Cancer Association, Colorectal Surgeon Expert Group, Surgeon Branch, Chinese Medical Doctor Association   

  1. 1. General Surgery Center, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
    2. Department of Colorectal Surgery, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
    3. Department of General Surgery (Colorectal Surgery Division), the Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou 510655, China
  • Received:2026-06-12 Published:2026-08-25
引用本文:

中华医学会外科学分会结直肠外科学组, 中国抗癌协会大肠癌专业委员会, 中国医师协会外科医师分会结直肠外科医师专家组. 结直肠癌人工智能应用场景评测专家共识(2026版)[J/OL]. 中华结直肠疾病电子杂志, 2026, 15(04): 289-298.

Colorectal Surgery Group, Chinese Society of Surgery, Chinese Medical Association, Colorectal Cancer Committee, China Anti-Cancer Association, Colorectal Surgeon Expert Group, Surgeon Branch, Chinese Medical Doctor Association. Expert consensus on evaluation standards for artificial intelligence applications in colorectal cancer (2026 edition)[J/OL]. Chinese Journal of Colorectal Diseases(Electronic Edition), 2026, 15(04): 289-298.

结直肠癌诊疗场景中人工智能(AI)技术正在快速进入肿瘤筛查、内镜诊疗、影像和病理分析、治疗决策、手术辅助和随访管理等环节,但不同系统在任务定义、数据来源、验证方式、性能指标、安全边界和真实临床适用性方面差异明显,亟须建立面向结直肠癌专病场景的评价框架。为此,中华医学会外科学分会结直肠外科学组、中国抗癌协会大肠癌专业委员会和中国医师协会外科医师分会结直肠外科医师专家组召集国内结直肠外科、消化内镜、影像、病理、肿瘤内科、放疗、AI、医学统计、医疗信息化、伦理与法规等领域的专家组成工作组,基于文献检索、现有指南和监管文件梳理、专家函询及会议讨论,提出了13条推荐意见,并按证据等级和推荐强度进行标注,制定了《结直肠癌人工智能应用场景评测标准专家共识(2026版)》。本共识提出以算法性能、临床安全、临床效用、用户体验、可解释性、伦理合规和持续监管为核心的分层评价框架,重点明确内镜辅助检出、影像和病理辅助诊断、生成式AI和辅助决策、手术相关AI、真实世界监测等场景的评价要求。本共识同时强调,AI系统应定位为临床辅助工具,不能替代临床医师独立作出诊断、治疗或手术决策。结直肠癌AI系统进入临床应用前,应完成与风险等级相匹配的验证,设置专病安全红线,落实医师复核和全生命周期监管。

Artificial intelligence (AI) technologies are rapidly being applied across all segments of colorectal cancer management, including cancer screening, endoscopic diagnosis and treatment, imaging and pathological analysis, therapeutic decision‐making, intraoperative assistance, and follow‐up management. Nevertheless, substantial disparities exist among various AI systems in terms of task definition, data sources, validation methodologies, performance metrics, safety thresholds, and real‐world clinical practicability. There is an urgent need to establish a dedicated evaluation framework tailored to clinical scenarios specific to colorectal cancer. To address this demand, the Colorectal Surgery Group of the Chinese Society of Surgery (Chinese Medical Association), the Colorectal Cancer Committee of China Anti‐Cancer Association, and the Colorectal Surgeon Expert Group of the Surgeon Branch (Chinese Medical Doctor Association) jointly assembled a working group composed of specialists covering colorectal surgery, digestive endoscopy, medical imaging, pathology, medical oncology, radiation oncology, artificial intelligence, medical statistics, medical informatization, medical ethics, and regulations. Through systematic literature retrieval, collation of existing clinical guidelines and regulatory documents, expert letter consultations, and panel discussions, the working group formulated 13 recommendations graded by levels of evidence and strength of recommendation, and developed the Expert Consensus on Evaluation Standards for Artificial Intelligence Applications in Colorectal Cancer (2026 Edition). This consensus establishes a tiered evaluation framework centered on seven core dimensions: algorithmic performance, clinical safety, clinical efficacy, user experience, model interpretability, ethical compliance, and continuous supervision. It further clarifies targeted evaluation requirements for key AI application scenarios, including AI‐assisted lesion detection during endoscopy, AI‐aided diagnosis via imaging and pathological slides, generative AI and clinical decision support, intraoperative AI assistance, and real‐world surveillance of AI systems. The consensus underscores that AI systems shall only serve as auxiliary clinical tools and must not replace clinicians to independently render diagnostic, therapeutic or surgical decisions. Prior to clinical deployment, all AI systems for colorectal cancer shall undergo rigorous validation commensurate with their risk classification, implement disease‐specific safety red lines, mandate mandatory clinician review, and enforce full‐lifecycle supervision throughout clinical use.

表1 证据等级与推荐强度[6-7]
图1 结直肠癌人工智能应用场景评测标准专家共识总体框架图(绘图人:张寅萌)。注:MDT为多学科诊疗
表2 人工智能系统安全红线与处置机制
表3 人工智能(AI)临床应用效用评价指标体系
应用场景 评价目标 核心评价指标 安全红线 推荐验证方式
内镜AI系统 提高结直肠早期病变检出能力 腺瘤检出率(ADR)、息肉检出率、漏诊率、平均检出时间 高级别病变(T1癌或高级别上皮内瘤变)漏检 前瞻性随机对照试验(RCT)或多中心真实世界研究
影像AI系统 提高术前分期与风险评估准确性 T/N/M分期准确率、曲线下面积(AUC)、敏感度、特异度 分期错误导致治疗路径改变(过度或不足治疗) 多中心外部验证队列研究
病理AI系统 提高病理诊断一致性与准确性 诊断一致性、Kappa系数、误诊率 癌与非癌误判或关键分型错误 病理金标准对照多中心研究
辅助决策系统 提高治疗决策规范性与一致性 多学科团队(MDT)一致性(Kappa)、指南符合率、推荐正确率 错误治疗建议(禁忌治疗、过度治疗或治疗延误) MDT对照研究、回顾性真实世界数据分析
手术相关AI系统 提高手术安全性与根治质量 R0切除率、环周切缘(CRM)阳性率、并发症发生率 关键解剖结构误识别导致器官损伤或功能损害 前瞻性队列研究、手术视频回顾分析
随访与管理AI系统 提高复发监测效率与随访依从性 复发检出提前时间、随访依从率、失访率 复发漏报或延迟干预 真实世界队列研究
生成式AI系统 提供规范化临床信息支持与建议 指南一致性、回答正确率、专家一致性(Kappa) 错误治疗建议或违反临床禁忌输出 医师盲法评价、MDT一致性研究
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