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机器人胃癌根治术:研究进展与实践挑战

  • 李斌 ,
  • 梁寒 , *
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  • 天津医科大学肿瘤医院胃部肿瘤科,恶性肿瘤国家临床医学研究中心,天津市消化系统肿瘤重点实验室,天津市恶性肿瘤临床医学研究中心,天津 300060

收稿日期: 2025-12-03

  网络出版日期: 2026-03-11

基金资助

天津市消化系统肿瘤重点实验室自主课题(HX24-7)

天津医科大学肿瘤医院国家自然科学基金培育项目(220104)

天津市医学重点学科建设资助(TJYXZDXK-3-003A)

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版权所有,未经授权,不得转载。

Robotic gastrectomy: Research progress and practical challenges

  • Bin LI ,
  • Han LIANG , *
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  • Department of Gastric Surgery, Tianjin Medical University Cancer Institute & Hospital; National Clinical Research Center for Cancer; Tianjin Key Laboratory of Digestive Cancer; Tianjin's Clinical Research Center for Cancer, Tianjin 300060, China
LIANG Han, e-mail,

Received date: 2025-12-03

  Online published: 2026-03-11

Supported by

Research fund of Tianjin Key Laboratory of Digestive Cancer(HX24-7)

National Natural Science Foundation of China Cultivation Project of Tianjin Medical University Cancer Hospital(220104)

Tianjin Key Medical Discipline Construction Project(TJYXZDXK-3-003A)

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All rights reserved. Unauthorized reproduction is prohibited.

摘要

胃癌是全球发病率和死亡率最高的恶性肿瘤之一,我国病例数及死亡数均居前列。随着腔镜技术和手术机器人系统的普及,胃癌外科已进入了微创时代。机器人胃癌根治术(robotic gastrectomy,RG)在复杂淋巴结清扫和消化道重建中展现出独特价值,且在减少术中失血、加快恢复速度和降低并发症方面相对腹腔镜胃癌根治术(laparoscopic gastrectomy,LG)更具有优势,但手术时间长和费用高仍是RG的劣势。目前,国内外指南均将RG纳入早期及部分局部进展期胃癌的治疗适应证,但强调需在经验丰富的医疗中心开展。同时,吲哚菁绿(indocyanine green,ICG)近红外光成像示踪技术引导淋巴结清扫、减孔/单孔手术、5G远程手术及人工智能融合等新技术的不断涌现,正在推动RG向精准化和智能化发展。本文系统梳理国内外临床研究和指南共识,重点评估RG的技术特点、学习曲线、短期/远期疗效和适应证扩展,分析其主要局限性,并对未来发展方向进行前瞻性讨论。

本文引用格式

李斌 , 梁寒 . 机器人胃癌根治术:研究进展与实践挑战[J]. 北京大学学报(医学版), 2026 , 58(2) : 416 -422 . DOI: 10.19723/j.issn.1671-167X.2026.02.030

Abstract

Gastric cancer is one of the malignant tumors with high incidence and mortality rates globally, with China ranking among the top 5 in both case numbers and deaths. With the popularization of laparoscopic technology and surgical robotic systems, gastric cancer surgery has entered the era of minimally invasive procedures. Robotic gastrectomy (RG) demonstrates unique value in complex lymph node dissection and digestive tract reconstruction, outperforming laparoscopic gastrectomy (LG) in terms of intraoperative blood loss, recovery speed, and certain complications. However, the longer operation time and higher costs remain disadvantages of RG. Currently, both domestic and international guidelines include RG in the treatment indications for early and some locally advanced gastric cancer, emphasizing that it should be performed in experienced medical centers. Meanwhile, new technologies such as indocyanine green (ICG) near-infrared imaging-guided lymph node dissection, reduced-port/single-port surgery, 5G remote surgery and integration with artificial intelligence are continuously emerging, driving RG towards precision and intelligence. This article systematically reviews clinical research and guideline consensus from both domestic and international sources, focusing on evaluating the technical characteristics, learning curve, short-term/long-term efficacy and expansion of indications for RG. It analyzes its main limitations and provides a prospective discussion on future development directions.

胃癌是常见的腹部恶性肿瘤之一,2022年全球新增胃癌病例超过96.9万,死亡病例超过65万,发病率和死亡率均位居全球前五[1-2]。我国是胃癌高发国家之一,每年新发及死亡病例数占全球患者数量的近一半[3-4]。目前根治性手术切除联合系统治疗仍是可切除胃癌的核心治疗方式。随着微创时代的到来,腹腔镜胃癌根治术(laparoscopic gastrectomy,LG)经多项随机对照试验(randomized controlled trial,RCT)研究证实,在早期及部分局部进展期胃癌中可获得与传统开腹手术相当的长期生存,并显著减少失血和术后疼痛,缩短住院时间[5-9]。2002年日本学者Hashizume等[10]首次报道达芬奇机器人胃癌根治术(robotic gastrectomy,RG)后,近20年来,学者们开展了一系列回顾性队列、Meta分析和RCT研究,对RG的学习曲线、手术安全性、淋巴结清扫质量、长期生存和成本效益等方面进行了评价。

1 RG在胃癌治疗中的技术优势与局限

1.1 技术优势

机器人手术系统采用主从式操作系统,由医师控制台、成像系统和床旁手术器械臂系统3部分组成。该系统有效克服了传统腹腔镜手术存在的二维视野限制、人体工学缺陷、生理性震颤及操作空间狭窄等问题。其三维成像技术能够提供10~15倍的放大效果,极大地扩展了手术视野,可清晰展示解剖结构。通过三维成像系统,手术器械实现了立体视野定位,从而显著提高了手术操作的精准性。此外,医生操作平台的设计允许主刀医生以坐姿方式进行手术,在人体工学方面为医生带来益处,减少了手术过程中的人为误差,并提升了手术质量。机械臂(EndoWrist)具备7个自由度,能够模拟人手在腹腔内的灵活运动,并通过计算机接口有效过滤生理性震颤,进一步有利于术者的操作[11-12]

1.2 技术局限

现有的机器人手术系统在触觉反馈方面存在显著不足,导致医生只能依赖视觉判断评估,这在一定程度上增加了术中血管损伤及吻合口狭窄的风险[13-14]。目前机器人手术系统中使用的超声刀主要为直线型,缺乏灵活的腕式关节,导致其在上腹部复杂空间的可达性及安全夹闭角度受到限制,与腹腔镜超声刀相比,机器人超声刀在这些方面并无明显优势[15]。多项大型队列研究及meta分析显示,RG的手术时间通常比LG延长30~60 min[16-19],主要是因为装机时间长。此外,经济学研究表明,RG所需的额外设备和耗材成本难以通过术后恢复时间的缩短完全抵消[20-22]。因此,优化团队协作流程、缩短装机对接时间以及利用国产机器人系统降低使用成本,是我国推广机器人手术面临的现实挑战。

2 指南中对RG的定位与建议

2.1 国外指南

基于部分RG的研究证据,日本胃癌学会(Japanese Gastric Cancer Association,JGCA)于2023年发布指南指出,在具有经验丰富和严格质控的医疗中心,RG作为弱推荐可用于临床Ⅰ期患者[23]。2022年欧洲内科肿瘤学会(European Society for Medical Oncology,ESMO)发布的指南认为,RG和LG在早期及部分局部进展期胃癌患者中能够实现与开腹手术相当的长期生存结果,但由于RG的证据主要来自于观察性研究,其在推广应用时应保持谨慎态度[24]。2025年美国国家癌症综合网络(National Comprehensive Cancer Network,NCCN)发布的指南也指出,对于早期和部分局部进展期可切除胃癌病例具有丰富经验的团队,其在实施RG和LG的安全性方面与开腹手术相当,但该指南并不推荐在T4b或融合淋巴结病变患者中常规采用包括RG在内的微创治疗方式[25]

2.2 国内指南

2016年,我国首次颁布《机器人胃癌手术专家共识(2015版)》[26],系统界定了RG的适应证范围、技术操作规范及围术期管理要求,并明确指出RG的适应证原则上应与LG保持一致。《机器人胃癌手术中国专家共识(2021版)》[27]进一步将RG主要适应证明确为:(1)肿瘤浸润深度≤T4a级;(2)术前肿瘤分期为Ⅰ、Ⅱ期;(3)对于具备丰富胃癌手术经验且熟练掌握机器人手术系统操作经验的外科医师,可应用机器人手术系统为术前肿瘤分期为Ⅲ期或需行联合器官切除的患者开展手术。同时,该共识也强调,仍需不断探索机器人系统在高难度手术,如保功能胃癌手术、单孔机器人手术以及联合器官切除手术中的应用,进一步加强其临床循证医学研究。

3 RG的学习曲线

学习曲线分析是评估外科新技术临床应用可行性的重要指标。Zhou等[28]研究发现,RG操作时间在完成约30例后趋于稳定;而淋巴结清扫数量和围手术期并发症发生率在更早阶段即达到稳定水平。Li等[13]通过前瞻性对照研究比较了3D LG与RG,发现RG组在完成30~40例手术后,手术时间显著缩短,同时D2淋巴结清扫范围和淋巴结清扫数量一直维持在较高水平。Staderini等[29]的分析进一步揭示了RG学习曲线的多阶段性特征——学习期(1~27例)、熟练期(28~48例)和精通期(49~83例),且淋巴结清扫数量在完成41例后可达超过D2清扫推荐阈值的平台期。系统评价和meta回归分析结果表明,对于具有丰富腹腔镜手术经验的医疗团队而言,RG的学习曲线周期普遍短于传统LG手术[29-31],国内学者的相关研究也得到了类似的结果[32-34]。另外,Kim等[35]通过一项多中心前瞻性试验(NCT01309256),系统分析了RG的学习曲线及其相关并发症,认为25例后可跨越初始学习曲线,88例后可达到技术精通水平,同时揭示了技术不成熟对手术结局的显著影响。这些研究结果表明,在具备丰富LG经验的基础上,外科医生可以较快掌握机器人手术技术。然而,目前大多数研究为单中心研究,且采用的评价标准存在差异,将来仍需开展采用统一评价标准的多中心前瞻性研究来进一步验证这些发现。

4 RG的短期疗效

4.1 淋巴结清扫质量

已发表的多项倾向性评分匹配(propensity score-matching,PSM)研究和meta分析结果表明,在D2淋巴结清扫范围内,RG在淋巴结清扫数量方面与LG相当[17, 36-42],甚至可能更具优势[18-19, 37, 43-57]。尤其是在解剖难度较高的区域,如胰腺上缘和脾门,RG展现出更优异的清扫效果[39, 44-50, 58]。吲哚菁绿(indocyanine green,ICG)近红外光成像示踪技术有助于提升RG的淋巴结清扫数量,同时不会导致术后并发症发生率增加[59-64]。最新研究显示,将ICG荧光显影技术与减孔RG相结合,有望在减少手术切口数量的同时保证淋巴结清扫的彻底性[65]

4.2 RG在消化道重建中的优势

机器人手术系统在消化道全腹腔内重建方面展现出显著优势。多项临床研究表明,机器人手术系统可显著缩短食管空肠吻合时间[66],亦适用于相对复杂的双通道重建[57]或双肌瓣吻合[67],在确保吻合安全性的同时,能够有效改善患者术后营养状态,并控制反流症状。关于RG中全腹腔内重建技术已有较多临床报道[68],经验丰富的医疗中心可实施全腹腔内重建,以减少辅助切口相关的术后并发症发生率。

4.3 RG的保功能效果

保功能手术(如保留幽门、近端胃切除及迷走神经保留术)对解剖辨识和缝合技术提出了更高要求。现有研究表明,应用RG行保留幽门胃切除术时,可在维持胃排空功能、降低胆囊结石发生率等方面展现出良好效果[69];RG还可精细识别迷走神经干及分支、幽门神经支和肝神经支,有助于提高患者的术后生活质量[70]

4.4 RG在超重患者中的应用

在超重患者中,腹腔脂肪丰富、暴露困难是腹腔镜手术的重要瓶颈。对于体重指数(body mass index,BMI)≥25 kg/m2的患者,RG能显著降低其术中出血量和中转开腹的比率[45, 71-72],缩短术后首次排气时间和进食时间[73],且RG组患者淋巴结清扫数量不会因BMI升高而减少[74]。有报道认为LG在超重患者中表现出更明显的手术时间延长及清扫质量下降趋势[75]

4.5 局部进展期及新辅助治疗后患者行RG的安全性与有效性

对于局部进展期胃癌患者行RG的安全性和可行性,现有证据主要来源于多中心回顾性研究及PSM分析,其结果显示RG在淋巴结清扫数目及R0切除率等方面并不劣于LG[41]。近期的研究表明,针对接受新辅助治疗后的患者,RG同样安全可靠[48, 76-79]。然而,现有证据质量受限且随访周期较短,目前仍缺乏以长期生存率为主要终点指标的前瞻性随机对照研究。

4.6 RG在复杂病例中的应用优势与证据局限

目前,RG已应用于包括残胃癌[80]、内脏全反位[81]以及存在血管变异[82]等相对复杂的病例,这得益于机器人系统多自由度的机械臂和稳定的三维高清视野,尤其是在狭窄手术空间或存在显著解剖变异的情况下更具有明显优势。然而,目前相关临床证据主要来源于个案报道或小样本回顾性研究,因此,其循证医学证据等级较低。

4.7 RG的围手术期并发症

现有的研究数据表明,RG在Clavien-Dindo分级≥Ⅱ级的术后并发症发生率[16, 46, 83-84]、术中出血量[38-39, 53, 85-87]、术后疼痛程度/镇痛药使用时间[44, 88]、术后住院时间[17, 39, 46, 52, 89]等方面均优于LG。Lu等[90]开展的随机对照试验研究(FUGES-011)揭示,RG在术中出血量控制、减少内科相关并发症、加快术后恢复速度及缩短术后辅助化疗开始时间等方面优于LG。其他RCT研究结果进一步证实,相比于LG,RG具有术中失血量少、输血需求低、腹腔感染发生率低等优势,并可以减少胰腺相关并发症发生率[8, 16, 44, 50, 91-92]。日本JCOG1907研究是首个探索RG安全性的多中心Ⅲ期RCT研究,计划纳入1 040例cT1-4aN0-3胃癌患者,随机分至RG组或LG组,分层因素包括机构、临床分期(cT1N0/cT1N1-3或cT2-4aN0-3)和胃切除类型(远端胃/全胃),其研究结果尚待后续数据披露[93]

5 RG的远期疗效

多项回顾性研究和Meta分析研究结果显示,RG与LG在3年或5年总生存率(overall survival,OS)和无进展生存率(progression free survival,PFS)方面无显著差异[36, 40, 49-52, 84, 94-99],尤其是近期发表的纳入超过万例患者的研究结果也支持这一结论[18, 54, 56]。Lu等[100]关于RG与LG治疗可切除胃癌的Ⅱ期RCT研究结果显示,RG组的3年OS和PFS均优于LG组。
笔者所在中心的一项回顾性研究纳入了天津医科大学肿瘤医院胃部肿瘤科2016年1月至2020年1月期间接受微创胃癌根治性手术的874例患者,分为LG组(719例)和RG组(155例),采用PSM分析,最终在LG组和LG组中各匹配出150例患者(1 ∶ 1),比较两组患者的短期临床疗效及5年OS[101]。结果显示,RG组和LG组的5年OS相似(P=0.235);与LG组相比,RG组术中出血量更少(P=0.011)、术后并发症发生率更低(P=0.001)、术后疼痛程度更低(P=0.014)、开始进食软食的时间更早(P=0.010)、住院时间更短(P=0.011),但住院费用更高(P=0.004)。这一研究结果表明,RG与LG的术后总体生存结果相似,但RG在减少术中出血量、降低手术并发症发生率、加快术后恢复速度及减轻术后疼痛方面具有更好的安全性和有效性。

6 RG的展望

6.1 特殊类型手术:减孔、单孔与单人手术

随着机器人系统器械和端口布局的改进,减孔乃至单孔RG逐渐应用于临床。研究证据表明,减孔RG在手术安全性和淋巴结清扫效果评价方面与常规RG相当,具有切口较小且隐蔽、术后疼痛程度较轻的优势[102-103],未来有望逐步发展为单孔RG,但目前仍处于可行性探索阶段。单人手术模式通过机器人手术系统配合自动镜头控制和器械管理系统,实现了主刀医师独立完成全部RG手术操作(无需助手),临床数据显示,该模式并未延长手术时间,也未增加并发症发生率[104]

6.2 触觉反馈

机器人手术系统缺乏触觉反馈,需要术者凭视觉判断组织的张力和缝合的紧密程度,从而施加适当的牵拉力量。目前已有气动驱动且具备实时触觉反馈的临床适用机器人操作系统的报道[105],但尚未在临床普及。

6.3 5G远程机器人手术

5G技术以高带宽、低时延和高可靠性为特点,为远程机器人手术提供了基础保障。基于5G网络的远程RG临床实践显示,所有患者术后均顺利实现康复,这反映出5G远程RG的可行性和安全性[106-107]。FUTURE-04研究显示,5G远程RG在技术可行性(延迟<300 ms)和短期安全性(无严重并发症)方面表现优异[108],这进一步证明在严格病例选择和完善预案保障下,5G远程RG在围手术期安全性方面是可行的。但远程手术仍面临网络延时波动和中断风险,以及跨地域协作、法律责任和隐私保护等问题。未来需通过多中心研究验证其长期安全性和经济学成本效益,并重点探索其在边远地区胃癌手术中的应用,以缩小高水平外科资源的地域差异。

6.4 与人工智能的深度融合

人工智能在胃癌手术中应用场景广泛[109-110],包括影像分割、血管标记、病灶边缘识别和治疗效果评估等,比如术前通过CT/MRI识别血管变异和淋巴结分布,生成导航图;术中结合荧光显像和图像分割显示血管和淋巴系统三维图像;术后通过视频分析建立质量评估体系。目前的研究多局限在原型开发阶段或回顾性研究,距离临床应用仍有差距,未来需解决系统接口开放、数据共享和算法训练等问题。

6.5 高质量前瞻性RCT研究与多中心协作

近年来虽已开展多项RG与LG疗效对比的RCT研究,但样本量和随访时间有限,主要终点仍以短期结局为主[16, 44, 65, 79, 83, 90],长期生存结局相关研究数量较少[99-100]。正在进行的日本JCOG1907研究将OS和DFS设为次要研究终点[93];我国也正在招募患者入组RCT研究——CLASS-13(机器人和腹腔镜根治性全胃切除术在局部进展期胃中上部癌中临床疗效的前瞻性、多中心、随机、对照研究)及CLASS-14(机器人和腹腔镜胃癌根治术在新辅助治疗胃癌患者中临床疗效的前瞻性、多中心、随机、对照研究),以探索RG与LG在胃癌患者中的长期生存结局,并提供更高等级的循证证据。
综上所述,目前的证据显示,RG在早期及局部进展期胃癌患者中展现出不劣于LG的短期疗效,同时也初步观察到与LG相当的长期生存获益趋势,并有术中出血少、术后恢复快等特点,尤其在肥胖患者和复杂解剖区域淋巴结清扫方面具有优势。然而,机器人手术系统仍存在触觉反馈缺失、手术成本高、高等级循证证据不足等挑战,未来需通过机器人手术系统迭代、结合5G远程手术、人工智能融合及高质量RCT研究证据进一步验证并扩展其临床应用价值。

利益冲突  所有作者均声明不存在利益冲突

作者贡献声明  李斌:文献搜集,文章撰写;梁寒:写作框架构思,最终修改和定稿。所有作者均参与论文修改,并对最终文稿进行审读和确认。

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