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中华胃肠内镜电子杂志

中华胃肠内镜电子杂志 ›› 2025, Vol. 12 ›› Issue (03) : 147 -176. doi: 10.3877/cma.j.issn.2095-7157.2025.03.002

共识与指南

超级微创手术治疗消化道肿瘤的临床实践指南(2025年，北京)
中华医学会消化内镜学分会, 世界内镜组织超级微创委员会   
  1. 100710　北京，中华医学会消化内镜学分会
    100853　北京，世界内镜组织超级微创委员会
  • 收稿日期:2025-04-02 出版日期:2025-08-15

Clinical practice guidelines for super minimally invasive surgery of digestive tract tumors (2025, Beijing)

Chinese Society of Digestive Endoscopology, Beijing 100700, China, SMIS Committee of World Endoscopy Organization, 100853 Beijing, China   

  • Received:2025-04-02 Published:2025-08-15
  • Supported by:
    National Key Research and Development Program of China(2022YFC2503600)
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中华医学会消化内镜学分会, 世界内镜组织超级微创委员会. 超级微创手术治疗消化道肿瘤的临床实践指南(2025年，北京)[J/OL]. 中华胃肠内镜电子杂志, 2025, 12(03): 147-176.

Chinese Society of Digestive Endoscopology, Beijing 100700, China, SMIS Committee of World Endoscopy Organization, 100853 Beijing, China. Clinical practice guidelines for super minimally invasive surgery of digestive tract tumors (2025, Beijing)[J/OL]. Chinese Journal of Gastrointestinal Endoscopy(Electronic Edition), 2025, 12(03): 147-176.

用于治疗消化道肿瘤的"器官切除，解剖重建"模式虽然能治愈疾病，但手术切除重要结构(如贲门、幽门、肛门)与消化道重建改变了生理解剖结构，术后并发症多且严重影响患者生活质量(如近端胃切除术后导致顽固性胃食管反流、胃大部切除术后倾倒综合征、低位直肠术后肛门功能丧失等)。针对这一模式的不足，2016年令狐恩强教授提出一种全新的理念—"治愈疾病、恢复如初"，并将其命名为"超级微创手术(SMIS)"[1]，为实现各种类型的SMIS，发展了四种手术通道：经自然腔道、隧道、穿刺及多腔隙通道。SMIS因创伤小、器官功能保留优势显著，被国内外权威机构认可并快速发展。基于其临床价值及推广需求，亟需制定规范化指南以指导实践。世界内镜组织超级微创委员会(SMIS Committee of World Endoscopy Organization)、中华医学会消化内镜学分会等机构牵头，联合消化内科、外科、病理科等多学科专家，共同制定《超级微创手术治疗消化道肿瘤的临床实践指南》 (以下简称《指南》)。本《指南》通过系统检索PubMed、Embase、中国知网等9大数据库中2025年前中英文文献，纳入随机对照试验、观察性研究及病例系列等证据，采用GRADE系统评估证据质量与推荐强度(高级证据：随机对照试验；低级证据：观察性研究)。推荐意见经多轮专家讨论与投票，并参照AGREE II和RIGHT标准报告。本《指南》在国际实践指南平台(PREPARE)注册(编号PREPARE-2024CN1183)。本《指南》针对食管癌、胃癌、结直肠癌及相应的癌前病变、以及十二指肠乳头癌前病变的SMIS治疗相关的15个问题，形成了相应的推荐意见。包括三大方面：(1)定义与原则：明确SMIS需满足器官保全、整块切除、无菌操作等十大核心准则，规范命名方式(如"食管下段鳞癌经口超级微创非全层切除术"); (2)术式推荐：食管癌：早期病变及癌前病变首选SMIS非全层切除术，环周范围≥1/2者推荐SMIS隧道法非全层切除术；创面≥75%周径需联合糖皮质激素或支架预防狭窄。胃癌：T1a-T1b期及癌前病变优先选择SMIS非全层或全层切除术，结合淋巴结转移(lymph node metastasis，LNM)风险分层制定个体化方案。结直肠癌：推荐T1a-T1b期及癌前病变患者行SMIS非全层或全层切除术；局部晚期直肠癌新辅助治疗后达临床缓解者，可尝试SMIS全层切除评估病理缓解。十二指肠乳头癌前病变：建议优先选择十二指肠乳头病变经口超级微创切除术，术后根据病理诊断决定是否追加胰十二指肠切除术及随访策略；(3)术后管理：构建了基于SMIS治疗早期胃癌(EGC)的治愈度评价体系，分为SMIS-Cure A(治愈)、SMIS-Cure B(临床治愈)和SMIS-Cure C(手术再评估)；并依据这一体系指导随访。结直肠癌或癌前病变术后以整块R0切除为治愈标准，按风险分层制定随访计划。本《指南》系统整合了SMIS在消化道肿瘤治疗中的循证证据与专家共识，确立了以器官功能保全为核心的规范化路径，有助于推动诊疗模式从"根治优先"向"根治-功能平衡"的转变，同时为未来技术迭代和适应证拓展等提供重要参考。

关键词: 超级微创手术, 食管癌, 胃癌, 结肠癌, 直肠癌, 癌前病变, 指南

The mode of organ resection and reconstruction that has been used to treat digestive tumors can cure the disease. However, it involves the surgical resection of critical structures (such as the cardia, pylorus, and anus) and gastrointestinal reconstruction, which alter the physiological anatomy of the digestive system. These changes often lead to numerous postoperative complications and severely affect the patient's quality of life (e.g., refractory gastroesophageal reflux following proximal gastrectomy, dumping syndrome after subtotal gastrectomy, loss of anal function after low rectal surgery). For the defect of this mode, in 2016, professor Linghu Enqiang proposed the new mode that was "curing the disease and restoring normal function", we named this new mode: Super Minimally Invasive Surgery (SMIS)[1]. To accomplish various types of SMIS, four operative channels were developed: the natural cavity channel, the tunnel channel, the puncture channel, and the multi-cavity channel. SMIS, with its advantages of minimal trauma and organ function preservation, has been recognized by authoritative domestic and international organizations and has developed rapidly. Based on its clinical value and the need for wider application, there is an urgent need to establish standardized guidelines to guide practice. This guideline was developed by leading organizations such as the SMIS Committee of World Endoscopy Organization and Chinese Society of Digestive Endoscopy (CSDE), in collaboration with multidisciplinary experts from gastroenterology, surgery, and pathology. Systematic searches were conducted in nine major databases, including PubMed, Embase, and China National Knowledge Infrastructure (CNKI), for both Chinese and English literature published before 2025.Evidence from randomized controlled trials, observational studies, and case series was included, with the quality of evidence and recommendation strength evaluated using the GRADE system (high-level evidence: randomized controlled trials; low-level evidence: observational studies). The recommendations were refined through multiple rounds of expert discussion and voting and reported according to AGREE II and RIGHT standards. The guideline has been registered on the International Practice Guidelines Platform (PREPARE, registration number PREPARE-2024CN1183). This consensus addresses 15 issues related to SMIS treatment for esophageal cancer, gastric cancer, colorectal cancer, their corresponding precancerous lesions, and precancerous lesions of the duodenal papilla. It provides corresponding recommendations in three main areas: (1) Definitions and principles: SMIS should meet ten core criteria, including organ preservation, complete resection(R0), and sterile procedures. It also standardizes naming conventions (e.g., "Super minimally invasive non-full-thickness resection of lower esophageal squamous carcinoma via the oral cavity" ). (2) Surgical recommendations: Esophageal cancer: For early and precancerous lesions, SMIS of non-full-thickness resection is preferred. For circumferential involvement ≥1/2, SMIS of tunnel approach for non-full-thickness resection is recommended. If the wound circumference is ≥75%, the use of corticosteroids or stents to prevent stenosis is advised. Gastric cancer: For T1a-T1b stage and precancerous lesions, SMIS non-full-thickness or full-thickness resection is preferred, with individualized plans based on the risk of lymph node metastasis (LNM). Colorectal cancer: SMIS of non-full-thickness or full-thickness resection is recommended as the first-line treatment for T1a-T1b stage and precancerous lesions. For locally advanced rectal cancer that achieves clinical remission after neoadjuvant therapy, SMIS of full-thickness resection can be considered to assess pathological remission. Duodenal papilla precancerous lesions: SMIS resection via the oral cavity is preferred. Postoperatively, whether to add pancreaticoduodenectomy and follow-up strategies should be determined based on pathology.(3) Postoperative management: A SMIS treatment cure evaluation system for early gastric cancer was established, divided into SMIS-Cure A (cured), SMIS-Cure B (clinically cured), and SMIS-Cure C (surgical reassessment), which guides follow-up. For colorectal cancer or precancerous lesions, R0 resection is the standard for cure, and follow-up plans are developed according to risk stratification. This guideline systematically integrates the evidence from SMIS in the treatment of gastrointestinal tumors with expert consensus, establishing a standardized pathway centered on organ function preservation. It shifts the treatment model from "cure first" to "cure-function balance". Its application is expected to reduce overtreatment, improve the patient′s quality of life, and provide a framework for future technological iterations and the expansion of indications. It should be continuously optimized with multi-center clinical data and long-term follow-up results to achieve more precise, individualized treatment.

Key words: Super minimally invasive surgery, Esophageal cancer, Gastric cancer, Colon cancer, Rectal cancer, Precancerous lesions, Guidelines
表2 GRADE证据等级与推荐建议
证据等级 具体描述 研究类型 总分 表达符号/字母
高级 非常确信真实的效应值接近效应估计 RCT质量升高二级的观察性研究 ≥0分 ⊕⊕⊕⊕/A
中级 对效应估计值有中等程度的信心：真实值有可能接近估计值，但仍存在二者大不相同的可能性 质量降低一级的RCT质量升高一级的观察性研究 －1分 ⊕⊕⊕○/B
低级 对效应估计值的确信程度有限：真实值可能与估计值大不相同 质量降低二级的RCT观察性研究 －2分 ⊕⊕○○/C
极低级 对效应估计值几乎没有信心：真实值很可能与估计值大不相同 质量降低三级的RCT
质量降低一级的观察性研究
系列病例观察
个案报道		 ≤－3分 ⊕○○○/D
推荐强度   具体描述 表达符号
强推荐 支持使用某项干预措施的强推荐 评价者确信干预措施利大于弊 ↑↑/1
  反对使用某项干预措施的强推荐 评价者确信干预措施弊大于利 ↓↓/1
弱推荐 支持使用某项干预措施的弱推荐 利弊不确定或无论高低质量的证据均显示利弊相当 ↑？/2
  反对使用某项干预措施的弱推荐 利弊不确定或无论高低质量的证据均显示利弊相当 ↓？/2
表1 本《指南》中使用的术语和定义
中文名称 英文名称 定义
超级微创手术 super minimally invasive surgery 指针对需要手术切除、切开的疾病，在保证器官解剖完整性不变基础上，达到祛除疾病目的的一类手术的统称。
早期癌 early-stage cancer 局限于黏膜和/或黏膜下层的恶性肿瘤，没有更深层次的受累，无论有无淋巴结转移。
整块切除 en-bloc resection 整块切除整个肿瘤、异型增生和/或癌变组织，而不是多块切除。
治愈性切除 curative resection 切除标本的组织学满足以下标准：(1)病理诊断水平和垂直切缘无恶性细胞；(2)一般分化程度良好；(3)无淋巴管、血管及神经侵犯；(4)未超出黏膜下层的深层侵袭；(5)不同类型的消化道肿瘤治愈性评价有更多细节判断。
肿瘤复发 cancer recurrence 病理诊断证实在既往切除或手术部位复发或淋巴结转移。
浸润深度 depth of invasion M1：上皮内非浸润性癌、原位癌；M2：进入固有层的微浸润性癌；M3：微浸润癌进入黏膜肌层；SM1：微浸润癌进入黏膜下层的上1/3(食管200以内、胃500以内、肠1 000以内); SM2：微浸润癌进入黏膜下层的中1/3 (食管200~400、胃500~1 000、肠1 000~2 000)；SM3：微浸润癌进入黏膜下层的下1/3 (食管400~600、胃1 000~1 500、肠2 000~3 000)。
异型增生 dysplasia 被定义为在组织学有明确的肿瘤性改变，但没有组织浸润证据的一类病变。这一术语与上皮内瘤变的区别在于异型增生指的是具有形态学上的肿瘤特征的病变。分为轻度异型增生、中度异型增生、重度异型增生。
上皮内瘤变 intraepithelial neoplasia 是一个用于描述"细胞或结构发生改变的一系列疾病"的术语，它被认为反映了潜在的分子生物学异常，可导致上皮内瘤变进展为浸润癌；分为高级别上皮内瘤变(high grade intraepithelial neoplasia，HIN)、低级别上皮内瘤变(low grade intraepithelial neoplasia，LIN)。
癌前病变 precancerous lesion 是一类容易发生癌变的病理组织学变化，包括异型增生和上皮内瘤变。
表3 根据早期胃癌的ESD后根治性切除的淋巴结转移风险
肿瘤特征 T1a T1b
无溃疡 有溃疡 黏膜下浸润
<500 μm ≥500 μm
大小 ≤2 cm >2 cm ≤3 cm >3 cm ≤3 cm 大小不限
分化型 <1% <1% <1% 3.0% 2.6% 1%~9%
未分化型 <1% 2.8% 5.1%   10.6%
图1 早期胃癌的SMIS术式选择策略注：M1：黏膜层；M2：黏膜固有层；M3：黏膜肌层；SM1：黏膜下层上1/3(500 μm以内)；SM2：黏膜下层中1/3(500~1000 μm)；SM3：黏膜下层下1/3(1000~1500 μm)；MP：固有肌层；Ad：浆膜层；Adj：侵犯至周边脏器
表4 早期胃癌SMIS-Cure治愈度评价体系(第一版)
SMIS-Cure A(治愈)： 满足特定肿瘤特征，术前评估无淋巴结转移证据，采用SMIS非全层或全层切除术，且术后病理诊断确认标本基底及切缘无病变残留、无脉管神经侵犯，可判定为SMIS治愈，术后常规随访。
肿瘤特征：(1)肿瘤直径任何尺寸，未合并溃疡的分化型黏膜内癌；(2)肿瘤直径≤2 cm，未合并溃疡的未分化型黏膜内癌；(3)肿瘤直径≤3 cm的未/合并溃疡的分化型黏膜下癌：SM1，浸润深度<500 μm。
SMIS-Cure B(临床治愈)： 分为B1和B2两个亚组，两者均需满足特定肿瘤特征，术前无淋巴结转移证据、采用SMIS全层切除术或经多腔隙通道SMIS保胃切除术(病变局部全层＋区域淋巴结切除)，且术后病理诊断确认标本基底及切缘无病变残留、无脉管神经侵犯和未发现淋巴结转移的标准，可判定为SMIS临床治愈，术后需要强化密切随访。
B1：肿瘤特征为(1)肿瘤直径≤3 cm的分化型黏膜下癌：SM2，浸润深度500~1 000 μm；(2)肿瘤直径≤2 cm未分化型黏膜下：SM1，浸润深度<500 μm；则判定为SMIS-Cure B1。
B2：肿瘤特征为(1)肿瘤直径≤3 cm的分化型黏膜下癌：SM3，浸润深度>1 000 μm；(2)肿瘤直径≤2 cm的未分化型黏膜下癌：SM2，浸润深度500~1 000 μm；术后需补充化疗和/或免疫治疗，且完成2次的密切强化随访，则判定为SMIS-Cure B2。
SMIS-Cure C(手术再评估)： 为可疑存在术后残留或高危因素(脉管神经侵犯或术后发现淋巴结转移)的需再评估手术，分为C1、C2、C3三个亚组。
C1：SMIS切除标本基底和/或切缘见病变残留，且无脉管神经侵犯和未发现淋巴结转移，需要复查内镜并在创面边缘残留端和/或基底面多点活检，若病理诊断结果阴性则判定创面病变无残留，需要内镜密切随访。
C2：SMIS切除标本基底及切缘见病变残留，且无脉管神经侵犯和未发现淋巴结转移，创面规范活检的病理诊断结果阳性，必须追加手术，且术后需要强化密切随访；SMIS术式按具体肿瘤特征选择：
(1)符合SMIS-Cure A肿瘤特征，且术后标本仅为边缘残留，需补充SMIS非全层或全层切除术；
(2)符合SMIS-Cure B肿瘤特征，且术后标本仅为边缘残留，需补充SMIS全层切除术；
(3)符合SMIS-Cure A(3)肿瘤特征，术后标本有黏膜下层基底残留，需补充经多腔隙通道SMIS保胃切除术；
(4)无论何种肿瘤特征，术后标本为固有肌层基底残留，需补充标准外科根治术。
C3：手术标本病理诊断提示脉管神经侵犯，或经多腔隙通道保胃切除术后发现淋巴结转移，或不符合SMIS-Cure A/B/C1，2者，后期必须追加标准外科根治手术。
图2 SMIS-cure评价术后补充治疗情况
图3 早期结直肠癌及高级别上皮内瘤变的SMIS策略选择、预后与随访
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