中国抗癌协会
立即下载App胃肠道肿瘤手术安全与质量控制未来展望篇——《中国恶性肿瘤学科发展报告（2024）》
1. 概述
胃肠肿瘤是全球性的健康挑战[1-4]，手术干预是治疗胃肠肿瘤的基石[3, 5, 6]，但各国的手术安全、质量、经济支出各不相同。长久以来，外科医生和研究人员一直尝试比较不同国家和地区之间的手术安全与质量。既往文献中常使用的衡量指标包括术后并发症、死亡率、非计划二次手术率等[7-14]。然而，由于在手术实践、并发症定义、医疗系统和其他因素方面存在显著差异和变化，对手术安全进行跨地区比较一直难以实现[15-18]。尽管如此，国内外的外科医生和研究人员一直努力应对这一挑战。传统上，常常使用Clavien-Dindo分级系统（Clavien Dindo Classification，CDC）分级系统[19, 20]和并发症综合指数（Charlson Comorbidity Index，CCI)[21]对术后并发症的严重程度进行衡量。最近，一些新兴的工具为不同外科实践的质量评估提供了新的思路，例如，国际上多个地区已经采用救援失败（failure to rescue，FTR）[22]、教科书结果（textbook outcome，TO）、benchmark[23]等指标来比较不同中心之间的手术质量[24-26]。此外，关于胃肠手术中最重要的并发症“吻合口漏”的国际共识已经建立[27-29]，以协助医疗专业人员在全球范围内进行标准化实践。
近些年，中国在胃肠道肿瘤手术安全与质量控制方面也取得了显著进展。20年前我国胃癌根治手术率<20%，而近年全国多中心数据显示，根治手术率已经提升到95%以上。然而，中国的胃肠肿瘤手术安全与质量控制与国际水平之间的关系尚不明朗。PACAGE（Prevalence of Abdominal Complications After Gastroenterological Surgery）数据库作为国内并发症登记的首次大规模尝试，可以提供中国胃肠肿瘤手术安全与质量控制的一瞥。本行业发展报告将对国内外胃肠肿瘤手术安全与手术质量进行综述，以《手术质量安全提升行动方案（2023-2025年）》为背景，旨在了解我国胃肠外科手术安全的真实水平，比较我国胃肠肿瘤外科手术与国际水平的相似性和差异性，为卫生医疗政策的制定给予最为详实的数据支撑[30-40]。
4. 本学科发展趋势与对策
4.1 未来5年发展的战略需求
持续的监测显示，近年来我国医疗机构开展的手术种类中位数和手术例次数快速增长，手术方法也不断改良，手术质量安全水平稳步提升，但包括手术并发症、麻醉并发症等在内的负性事件发生率在少数医疗机构呈上升趋势，需要进一步加强科学管理。因此，2023年，国家卫生健康委办公厅将“手术质量安全提升行动”作为《全面提升医疗质量行动计划（2023-2025年）》的子行动进行了安排[138]。同年，国家卫生健康委办公厅印发了《手术质量安全提升行动方案（2023-2025年）》，中国胃肠道肿瘤手术安全和质量控制进入了新的阶段[139]。其中提到，计划到“2025年末，住院患者围手术期死亡、手术并发症、麻醉并发症等负性事件发生率进一步下降，非计划重返手术室再手术率不高于1.8‰，住院患者手术后获得性指标发生率不高于7.5‰，手术麻醉期间低体温发生率、I类切口手术抗菌药物预防使用率进一步降低，日间手术占择期手术的比例进一步提高，四级手术术前多学科讨论制度得到全面落实”[139]。 通过精细化管理和技术创新，提升手术安全水平，保障患者生命健康，推动医疗质量持续改进，构建高效安全的手术环境，确保每一环节精准无误。在手术全流程中，严格把控术前评估、术中操作及术后监护。
4.2 未来5年重点发展方向
1. 数据库建设与大数据精准应用
未来将进一步完善全国范围内手术数据的采集与整合，依托PACAGE、CCCD等现有数据库，实现手术过程及术后随访数据的标准化、全面化收集。利用人工智能与大数据技术，对海量数据进行深度挖掘，构建精准风险评估与并发症预测模型，推动从经验驱动向数据驱动的转变。这一方面不仅能够实现实时动态监测、及时反馈手术安全指标，促进各医疗机构之间的经验对标和质量改进，还能为精准医疗提供科学依据，从而有效降低并发症发生率，提升患者预后水平。
2. 手术技术创新与标准化操作推广
未来五年，将持续推动微创、机器人辅助手术等前沿技术在临床中的应用。以胃肠肿瘤手术为例，通过推广D2根治术和腹腔镜手术技术，形成一套涵盖术前风险评估、手术操作、围术期管理及术后随访的全流程标准化操作规范。不断修订和完善国家级诊疗指南，结合多中心临床试验成果，建立严谨的质量评估指标体系，从而实现各手术中心之间水平对标、差距缩小和技术持续进步，确保新技术在提高疗效的同时具备高安全性。
3. 多中心协同研究与质量控制体系建设
以国家癌症中心为核心，我国将进一步强化多中心协同研究机制和全国统一的质量控制体系。通过整合全国各大医院和科研机构的资源，开展针对手术并发症、术后恢复和长期预后的大规模多中心临床研究，实现从术前、术中到术后的全过程监控和精细管理。同时，借鉴并对标国际NSQIP、日本NCD、荷兰DUCA（现改为DICA以覆盖更多癌种）及GlobalSurg等项目的经验，不断完善风险调整模型和质量评价指标，实现国内外标准的接轨和互通，从而推动我国手术质量控制体系迈向国际领先水平。
4. 人才培养与国际合作的深度拓展
高水平人才是推动手术安全与质量控制持续进步的关键。未来5年，我国将加大对外科技术、数据科学及质量管理领域高层次人才的培养和引进力度，通过国内外学术交流、专题培训及联合研究，提升医务人员整体素质。与此同时，深化与国际著名学术组织和质量控制项目（如NSQIP、NCD、DICA、NELA、GlobalSurg Collaborative）的合作，开展联合学术会议、互访研讨和合作研究，吸收和借鉴国际先进经验，不断优化和创新手术安全管理模式。
4.3 未来5年发展对策
在《手术质量提升计划（2023-2025年）》的指导下，未来中国胃肠道肿瘤手术的安全与质量控制可以从以下几个方面进行改进：
1. 完善顶层规划与标准体系建设
未来五年，我国应继续强化国家层面的政策引导和标准制定工作。依托国家癌症中心等权威机构，修订和完善《手术质量安全提升行动方案（2023-2025年）》及相关诊疗规范，形成涵盖术前风险评估、手术操作流程、围术期管理和术后随访的全流程标准体系。各级医疗机构需要依此开展自查与内控，通过制定统一的手术评价指标和质量反馈机制，实现跨区域、跨机构的对标与互查，确保手术操作的规范性和安全性。
2. 推动大数据与人工智能精准应用
构建和完善全国性手术数据库（如PACAGE、CCCD等）仍是未来发展的重要基础。通过持续数据采集、标准化数据录入和多维度分析，利用人工智能技术构建风险评估和并发症预测模型，为临床决策提供实时支持。各中心可建立数据共享平台，实现不同医院之间的信息互通和质量对比，并依托大数据挖掘开展精准医疗研究。这不仅能及时发现安全隐患，还能根据数据反馈动态调整手术流程，从而实现手术风险的精准管理。
3. 强化技术创新与多中心协同研究
在现有优势基础上，未来应进一步推动微创手术、机器人辅助手术、分子检测等新技术在临床中的应用与推广。重点开展包括腹腔镜手术、机器人辅助及新型影像学技术在内的多中心随机对照试验，验证新技术在降低并发症和改善患者预后方面的有效性。同时，构建以国家癌症中心为核心的多中心协同研究网络，开展涵盖多种癌种的临床路径研究和质量控制标准探索，实现从手术前、中、后全过程的精细管理，促进国内外经验对接与互鉴。
4. 加强人才培养与国际合作
高质量人才是技术创新和质量提升的根本保障。未来五年，要加大对外科、数据科学和质量管理等跨学科人才的培养力度，建立完善的培训和继续教育体系，通过举办国际学术会议、专题培训和联合研究，吸纳国际先进经验，缩小与欧美及日韩先进水平的差距。同时，深化与NSQIP、NCD、DICA、NELA及GlobalSurg等国际项目的交流合作，共同制定或更新手术安全和质量控制标准，提升我国在全球外科领域的话语权和影响力。
5. 强化基层和区域医疗资源下沉
在推动高端技术和标准体系建设的同时，也要注重基层和区域医疗机构的技术推广。通过建立示范基地和适宜技术推广网络，向县级、乡镇医院输送先进的手术安全管理经验和技术，缩小城乡、区域间医疗服务水平的差距。依托国家癌症防控信息平台，开展远程会诊和技术指导，确保各级医院均能执行统一标准，提升整体手术安全水平。未来需要更多关注基层医疗机构的技术培训和能力提升，以实现全国范围内的均衡发展。
结论
我国在胃肠外科手术安全与质量控制领域取得了显著进步。依托庞大的手术量、标准化的操作流程及PACAGE、CCCD等多中心数据库，我国实现了术前风险评估、手术过程管理和术后随访的全流程精准控制，有效降低了并发症和死亡率。国家癌症中心等顶层机构在制定国家级诊疗规范、构建全国信息平台和统一质量评价标准方面发挥了关键作用，并借鉴了国际先进经验。未来，将通过大数据与人工智能应用、微创及机器人手术技术创新、多中心协同研究、以及高层次人才培养和国际合作，进一步推动手术全流程标准化、精准化管理，提升我国外科整体水平，为保障公众健康提供坚实支撑。
【主编】
李子禹 北京大学肿瘤医院
季加孚 北京大学肿瘤医院
徐泽宽 南京医科大学第一附属医院（江苏省人民医院）
胡建昆 四川大学华西医院
【副主编】
余 江 南方医科大学南方医院
臧 潞 上海交通大学医学院附属瑞金医院
张万广 华中科技大学同济医学院附属同济医院
郑朝辉 福建医科大学附属协和医院
胡文庆 长治市人民医院
赵 岩 辽宁省肿瘤医院
赵 群 河北省肿瘤医院
陕 飞 北京大学肿瘤医院
吴舟桥 北京大学肿瘤医院
【编委】（按姓氏拼音排序）
顾庭菲 北京大学肿瘤医院
王敬普 郑州大学第一附属医院
★
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