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通讯作者:

邓正明,E-mail:dengzhengming@sohu.com

中图分类号:R735.2

文献标识码:A

文章编号:1007-4368(2023)03-349-08

DOI:10.7655/NYDXBNS20230308

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目录contents

    摘要

    目的:探讨新辅助化疗联合达芬奇机器人手术治疗进展期胃癌的安全性和可行性。方法:回顾性分析2018年7月 —2022年7月在南京中医药大学附属医院行术前新辅助化疗(SOX方案)联合腹腔镜或达芬奇机器人胃癌根治术的进展期胃癌151例,依据纳入排除标准最终纳入120例,依据手术方式分为达芬奇机器人辅助胃癌根治术组(机器人组)60例和腹腔镜下胃癌根治术组(腹腔镜组)60例,比较两组的临床资料、围手术期手术相关指标及术后康复指标。结果:两组的年龄、体重指数、肿瘤大小、肿瘤位置、手术范围、消化道重建方式、术前临床分期(cTNM分期)、病理分期(ypTNM分期)、细胞分化程度、肿瘤退缩分级、完全缓解及部分缓解情况差异无统计学意义(P>0.05)。两组手术时间、术中出血估计量、腹部切口长度差异均有统计学意义(P<0.05),而淋巴结清扫总数及转移淋巴结数目差异均无统计学意义(P>0.05)。两组术后疼痛评分、术后首次流质饮食时间、首次通气时间、腹腔引流管拔管时间及术后住院时间、住院费用差异均有统计学意义(P<0.05),并且两组术后C反应蛋白、白细胞计数、中性粒细胞计数、术后血清前白蛋白、白介素(interleukin,IL)-6、降钙素原差异也均有统计学意义 (P<0.05),而两组术后并发症发生率及术后30 d内再入院、术后30 d内二次手术情况差异均无统计学意义(P>0.05)。机器人组术中出血估计量、腹部切口长度、术后疼痛评分、术后首次流质饮食时间、术后首次通气时间、术后腹腔引流管拔除时间、术后住院时间均优于腹腔镜组,但手术时间、住院费用明显劣于腹腔镜组。结论:进展期胃癌采取术前新辅助化疗联合达芬奇机器人手术的策略是安全可行的,其术后并发症发生率与腹腔镜胃癌手术相似,达芬奇机器人手术是进展期胃癌新的候选治疗方式。

    Abstract

    Objective:This study aims to explore the safety and feasibility of neoadjuvant chemotherapy combined with Da Vinci robotic surgery for advanced gastric cancer. Methods:The respective cross - sectional study was conducted. There were 151 patients retrospectively analyzed,who underwent radical gastrectomy after two cycles of neoadjuvant chemotherapy(SOX)in the Affiliated Hospital of Nanjing University of Traditional Chinese Medicine from July 2018 to July 2022,and 120 cases were finally included according to the inclusion and exclusion criteria. According to mode of operation,all patients were divided into Da Vinci robotic radical gastrectomy group(robot group,60 cases)and laparoscopic radical gastrectomy group(laparoscopy group,60 cases). The general data, perioperative surgery related indexes and postoperative rehabilitation were compared between two groups. Results:There was no significant difference between the two groups in age,body mass index,tumor size,tumor location,surgical scope,digestive tract reconstruction mode,preoperative clinical stage(cTNM),pathological stage(ypTNM),cell differentiation degree,tumor regression grade,complete remission and partial remission(P > 0.05). There were significant differences between the two groups in operation time,estimated intraoperative bleeding and abdominal incision length(P<0.05). There were significant differences between the two groups in postoperative pain score,the time of first fluid diet,the time of first ventilation,the time of drainage tube extubation,the time of postoperative hospitalization and the cost of hospitalization(P < 0.05). There were also significant differences in C-reactive protein, leukocyte count,neutrophil count,serum prealbumin,interleukin(IL)- 6 and procalcitonin between the two groups(P < 0.05). However,there was no significant difference in the incidence rate of postoperative complications,readmission within 30 days after surgery,and secondary surgery within 30 days after surgery between the two groups(P > 0.05). In the robot group,the estimated amount of surgical bleeding,the length of abdominal incision,the score of postoperative pain,the time of first liquid diet,the time of first ventilation,the time of extraction of abdominal drainage tube,and the time of postoperative hospitalization were better than those in the laparoscope group,but the operation time and hospitalization cost were significantly worse than those in the laparoscope group. Conclusion:For advanced gastric cancer,the strategy of preoperative neoadjuvant chemotherapy combined with Da Vinci robotic surgery is safe and feasible,and the incidence of postoperative complications is similar to laparoscopic surgery. So,Da Vinci robotic surgery system is a new candidate for advanced gastric cancer.

  • 胃癌是全球最常见的消化系统肿瘤,其发病率居世界第5位,病死率居世界第4位[1]。而中国是胃癌高发国家,且大多数病例首诊时即为进展期[2]。手术是胃癌获得治愈的唯一有效手段,而对于胃癌伴有广泛淋巴结转移,包括腹主动脉淋巴结或沿着腹主动脉、脾动脉、肝总动脉等淋巴结转移的5年生存率低于 30%。术前新辅助化疗联合手术治疗策略对进展期胃癌的良好疗效获得多个高级别临床研究支持[3],《日本胃癌治疗指南》[4] 及《CSCO 中国胃癌指南》[5] 均指出新辅助化疗可有效降低肿瘤分期,增加手术机会,但同时新辅助化疗会加重肿瘤纤维化、间隙水肿粘连,进而导致手术难度增加。随着医疗水平的发展,腹腔镜技术因其精准、微创、术后并发症少等优点广泛应用于临床。多项研究表明新辅助化疗后行腹腔镜手术具有可靠的安全性和疗效[6-7]。近年来,达芬奇机器人辅助系统被视为微创手术的创新性应用之一,相比腹腔镜技术具有超高清 3D 视角、10 倍手术视野放大、有效过滤手部震颤、极高的自由度、减轻术者疲劳等优势[8]。目前有较多的临床研究报道达芬奇机器人胃癌根治术的安全性,Lu等[9] 研究发现达芬奇机器人胃癌根治术在减轻手术应激、促进术后康复等方面均优于腹腔镜手术。但目前关于达芬奇机器人手术应用于新辅助化疗胃癌的研究较少,因此,本研究旨在探讨新辅助化疗联合达芬奇机器人手术系统治疗进展期胃癌的安全性和短期临床疗效,为进展期胃癌的新治疗手段提供临床证据。

  • 1 对象和方法

  • 1.1 对象

  • 依据纳入标准选择 2018 年 7 月—2022 年 7 月在南京中医药大学附属医院收治的进展期胃癌患者151例,男109例,女42例,年龄57~71岁,中位年龄66岁。所有患者均已行术前腹部CT检查,且由胃镜病理组织活检诊断为胃恶性肿瘤。所有入选病例术前行 2 个周期的新辅助化疗,具体方案为 SOX 方案:奥沙利铂(130 mg/m2),静脉滴注 2 h,第 1天加用替吉奥(50 mg)口服,每天2次(第1~14天), 21 d为1个周期。术前主管医生详细告知患者及家属两种手术方式的信息,由本人自主选择。依据手术方式分为达芬奇机器人辅助胃癌根治术组(机器人组)和腹腔镜下胃癌根治术组(腹腔镜组)。本研究经医院伦理委员会批准(批件号:2021NL⁃149⁃ 03),患者及家属签署知情同意书。

  • 纳入标准:①病理组织证实为腺癌;②术前腹部 CT 或超声内镜临床分期为 cT2~4aN+M0;③术前新辅助方案为 SOX 方案;④无肝、脾、肠等脏器转移病灶;⑤术前美国麻醉医师协会(ASA)评分≤ 3 分;⑥手术方式为腹腔镜或达芬奇机器人辅助全胃或次全胃切除+D2淋巴结清扫术;⑦年龄>18岁。排除标准:①既往有胃手术史;②急诊手术、姑息手术和开腹手术方式;③残胃癌患者;④术中发现有腹膜和/ 或远处脏器转移者;⑤术后病理明确R1切除者;⑥病历资料不全或拒绝参与本次临床研究。

  • 1.2 方法

  • 1.2.1 手术方式

  • 体位取头高脚低 30°~45°。仰卧位,手术操作依据《机器人胃癌手术中国专家共识(2021版)》[10] 和《中国腹腔镜胃癌根治手术质量控制专家共识 (2022 版)》[11],同时结合日本第 15 版《胃癌处理规约》[12] 的推荐和江志伟教授的“斯诺克路径”[13] 进行 D2淋巴结清扫。手术范围包括近端部分胃切除、远端部分胃切除、全胃切除术。所有病例均行腹部辅助切口完成相应消化道重建:食管残胃吻合、Bill⁃ roth Ⅱ式、食管空肠Roux⁃en⁃Y吻合术。所有手术均由同一手术团队完成。

  • 1.2.2 观察指标

  • 一般临床资料:年龄、性别、体重指数(body mass index,BMI)、肿瘤大小、肿瘤位置、手术范围、消化道重建方式、术前临床分期(cTNM)、pT分期、pN分期、分化程度、肿瘤退缩分级、病理分期(ypTNM)、完全缓解(complete remission,CR)例数、部分缓解 (partial response,PR)例数。

  • 手术及术后情况:手术时间、术中出血估计量、腹部切口长度、淋巴结清扫总数、转移淋巴结数目、术后疼痛评分、术后首次通气时间、术后首次流质饮食时间、术后腹腔引流管拔除时间、术后住院时间、术后并发症、Clavien⁃Dindo并发症分级、住院费用、术后30 d内二次手术、术后30 d内再入院。

  • 实验室指标:C 反应蛋白(C ⁃ reactive protein, CRP)、白细胞计数、中性粒细胞计数、血清前白蛋白、降钙素原、白介素(interleukin,IL)⁃6。

  • 1.3 统计学方法

  • 数据分析采用SPSS 26.0统计软件。正态分布计量资料采用均值±标准差(x-±s)表示,两组间比较采用 t 检验;非正态分布数据采用中位数(四分位数)[MP25P75)]表示,两组之间比较采用Wilcoxon 秩和检验;定性资料用频数(构成比或率)表示,两组间定性资料比较采用χ2 检验或 Fisher 确切概率法;两组间等级资料采用秩和检验。P<0.05 为差异有统计学意义。

  • 2 结果

  • 2.1 机器人组和腹腔镜组一般资料的比较

  • 依据纳入标准本研究共计患者151例,再依据排除标准排除R1切除4例(机器人、腹腔镜各2例),腹膜转移行腹腔探查6例(腹腔镜4例,机器人2例),中转开腹4例(机器人、腹腔镜各2例),病历资料不全15例,急诊手术2例,最后纳入120例患者入组,其中腹腔镜组60例,机器人组60例。男89例,女31例,年龄58~70岁,中位年龄66岁,BMI(22.34±3.11)kg/m2。 R0 切除率 98.3%。两组患者的年龄、BMI、肿瘤大小、肿瘤位置、手术范围、消化道重建方式、术前 cTNM 分期、pT 分期、pN 分期、ypTNM 分期、细胞分化程度、肿瘤退缩分级(Ryan标准)、CR及PR情况,差异均无统计学意义(P>0.05,表1),具有可比性。

  • 2.2 两组围手术期手术及术后康复相关指标的比较

  • 如表2所示,两组患者在手术时间、术中出血估计量、腹部切口长度差异均有统计学意义(P< 0.05),而淋巴结清扫总数及转移淋巴结数目差异均无统计学意义(P>0.05)。两组术后疼痛评分、术后首次流质饮食时间、首次通气时间、腹腔引流管拔管时间、术后住院时间、住院费用差异均有统计学意义(P<0.05),而术后并发症发生率、术后30 d内再入院、术后 30 d 内二次手术情况,两组差异无统计学意义(P>0.05)。机器人组术中出血估计量、腹部切口长度、术后疼痛评分、首次流质饮食时间、首次通气时间、腹腔引流管拔除时间、术后住院时间要优于腹腔镜组,但手术时间、住院费用明显劣于腹腔镜组。

  • 2.3 两组炎症相关指标比较

  • 如表3所示,两组患者术前CRP、白细胞计数、中性粒细胞计数、血清前白蛋白、降钙素原、IL⁃6比较,差异均无统计学意义(P>0.05),两组数据具有可比性。两组术后 CRP、白细胞计数、中性粒细胞计数、血清前白蛋白、降钙素原、IL⁃6比较,差异均有统计学意义(P<0.05)。其中机器人组术后第 1、 3、5 天的血清前白蛋白高于腹腔镜组,而CRP、白细胞计数、中性粒细胞计数、降钙素原、IL⁃6水平均显著低于腹腔镜组(图1)。

  • 3 讨论

  • 我国是胃癌高发国家,且大多数病例首诊时属于进展期,手术治疗是胃癌获得临床治愈的唯一有效手段,但在伴有腹主动脉转移的病例中,3年生存率不足30%。术前新辅助化疗联合手术治疗策略,尤其是微创技术在进展期胃癌中的临床广泛应用,使得这部分进展期胃癌R0手术切除率和5年生存率显著提高[14-16]。术前新辅助化疗能有效杀死肿瘤细胞,降低肿瘤分期,提供手术机会,提高手术R0切除率且降低手术并发症发生率,改善术后生活质量,提高 5 年生存率。本研究两组 R0 切除率(96.7% vs.96.7%,P=1.00),与其他研究新辅助化疗后腹腔镜手术R0切除率(95%)相似[17]

  • 表1 两组一般资料比较

  • Table1 Comparison of general information between two groups

  • 表2 两组围手术期手术及术后康复相关指标的比较

  • Table2 Comparison of related indexes of perioperative operation and recovery between two groups

  • 表3 两组术前炎症相关指标的比较

  • Table3 Comparison of preoperative inflammation⁃related indicators between two groups

  • 胃周淋巴结清扫总数是影响胃癌预后的独立因素[18-19],与术后治疗方案选择密切相关,本研究中腹腔镜组和机器人组淋巴结清扫总数分别为(31.40± 11.12)枚和(32.20±12.97)枚,满足指南至少16枚的标准,两组之间的淋巴结清扫总数差异无统计学意义,这与Yun等[20] 研究结果相似,而对非新辅助化疗的研究显示达芬奇机器人手术的淋巴结清扫总数更多[21-24],这可能与淋巴结检出率和部分淋巴结消退甚至完全退缩相关,但需进一步临床研究证实。相比腹腔镜手术,达芬奇机器人手术有放大效果更高、3D显示更高清、7个自由度操作更灵活等优势,有助于更精准地解剖和病灶切除,更彻底地淋巴结清扫,增加复杂消化道重建的可行性。但机器人组的手术时间明显长于腹腔镜组,住院费用高于腹腔镜组,这些因素限制了达芬奇机器人手术在临床的广泛开展。

  • 图1 两组术后CRP(A)、白细胞(B)、中性粒细胞(C)、血清前白蛋白(D)、降钙素原(E)、IL⁃6(F)水平比较

  • Figure1 Comparison of CRP(A),leukocyte(B),neutrophil(C),prealbumin(D),procalcitonin(E)and IL⁃6(F)levels after operation between two groups

  • 在术后短期疗效评价指标中,本研究术后并发症发生率为6.67%(8/120)。其中,机器人组3例(肺部感染2例,不全性肠梗阻1例),腹腔镜组5例(肺部感染1例,腹腔感染1例,吻合口瘘1例,十二指肠残端瘘 1 例,不全性肠梗阻 1 例),两组差异无统计学意义,这与其他研究认为腹腔镜手术和机器人手术的总体并发症发生率无差异的结果一致[25⁃27]。两组比较发现机器人组在术后创伤恢复方面明显优于腹腔镜组,这与以往的一些研究结果相符[9],原因是相比腹腔镜手术,机器人手术能提供更加清晰的视野,并可使手术视野放大10倍以上,能有效过滤术者手部微小震颤,更大程度地减少患者术中副损伤,从而表现出更轻的炎症反应和更快的术后恢复。实验室数据和术后康复指标也同样支持这一观点。已经有大量研究认为白细胞、CRP、降钙素原和IL⁃6是与术后应激状态密切相关的指标[28-29],本研究使用这些指标反映术后创伤应激的程度。结果显示,机器人组术后第 1、3、5 天的白细胞、CRP、降钙素原、IL⁃6 均显著低于腹腔镜组。此外,机器人组术后康复时间(首次通气时间、首次流质饮食时间、腹腔引流管拔除时间、住院天数)也明显短于腹腔镜组,这间接反映机器人组的术后创伤与应激反应小于腹腔镜组,两组患者术后疼痛评分比较也能体现出达芬奇机器人手术带来的创伤与应激更小。

  • 但是达芬奇机器人手术也存在缺点:①机器人组的手术时间长于腹腔镜组,达芬奇机器人手术需要更长的手术准备时间[2130-31],需要时间装卸机械臂,并且初期术者机器人手术的操作流程不如腹腔镜熟练,造成手术时间过长。但机器人手术学习曲线的相关研究显示,随着装、停机熟练程度的提高和医护人员合作默契度的增加,机器人手术的时间将与腹腔镜手术时间相差无几[3032]。②达芬奇机器人系统设备费用、维护及损耗费用过高[9],导致总体治疗费用较高。本研究中,机器人手术费用明显高于腹腔镜手术费用。熟练的操作技巧和降低手术费用是达芬奇机器人系统临床普及的重要环节。

  • 本研究仍然存在一定局限性:①本研究为回顾性研究,存在一定的偏倚;②单中心的研究样本数量有限,未来需采用大样本研究以证明本研究结果的可靠性;③未收集远期疗效指标,未来可加入更多远期预后指标,为研究结果提供进一步证据;④随访时间太短,无法分析更长期的生存情况。

  • 综上,达芬奇机器人手术联合新辅助化疗治疗进展期胃癌和腹腔镜手术联合新辅助化疗具有相似的安全性和短期临床疗效。与腹腔镜手术相比,达芬奇机器人手术具有手术出血少、术后康复快、住院时间短等多种优势,未增加术后并发症发生率。但目前的研究结果需要更多的多中心随机对照研究提供更多的临床证据支持。

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    • [2] 王胤奎,李子禹,陕飞,等.我国早期胃癌的诊治现状 ——来自中国胃肠肿瘤外科联盟数据的启示[J].中华胃肠外科杂志,2018,21(2):168-174

    • [3] LI Z Y,SHAN F,YING X J,et al.Assessment of laparo⁃ scopic distal gastrectomy after neoadjuvant chemotherapy for locally advanced gastric cancer[J].JAMA Surg,2019,154(12):1093

    • [4] JAPANESE GASTRIC CANCER ASSOCIATION.Japa⁃ nese gastric cancer treatment guidelines 2021(6th edi⁃ tion)[J].Gastric Cancer,2023,26(1):1-25

    • [5] WANG F H,ZHANG X T,LI Y F,et al.The Chinese So⁃ ciety of Clinical Oncology(CSCO):clinical guidelines for the diagnosis and treatment of gastric cancer,2021[J].Cancer Commun,2021,41(8):747-795

    • [6] LIAO X L,LIANG X W,PANG H Y,et al.Safety and effi⁃ cacy of laparoscopic versus open gastrectomy in patients with advanced gastric cancer following neoadjuvant che⁃ motherapy:a meta ⁃ analysis[J].Front Oncol,2021,11:704244

    • [7] XING J Y,WANG Y K,SHAN F,et al.Comparison of to⁃ tally laparoscopic and laparoscopic assisted gastrectomy after neoadjuvant chemotherapy in locally advanced gas⁃ tric cancer[J].Eur J Surg Oncol,2021,47(8):2023-2030

    • [8] SONG J,OH S J,KANG W H,et al.Robot⁃assisted gas⁃ trectomy with lymph node dissection for gastric cancer [J].Ann Surg,2009,249(6):927-932

    • [9] LU J,ZHENG C H,XU B B,et al.Assessment of robotic versus laparoscopic distal gastrectomy for gastric cancer [J].Ann Surg,2020,273(5):858-867

    • [10] 中国研究型医院学会机器人与腹腔镜外科专业委员会,中国抗癌协会胃癌专业委员会.机器人胃癌手术中国专家共识(2021版)[J].中华消化外科杂志,2022,21(1):1-9

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    • [20] YUN J K,LEE I S,GONG C S,et al.Clinical utility of ro⁃ bot ⁃ assisted transthoracic esophagectomy in advanced esophageal cancer after neoadjuvant chemoradiation the ⁃ rapy[J].J Thorac Dis,2019,11(7):2913-2923

    • [21] SHIN H J,SON S Y,WANG B,et al.Long⁃term compari⁃ son of robotic and laparoscopic gastrectomy for gastric cancer[J].Ann Surg,2020,274(1):128-137

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