机器人与开腹胰十二指肠切除术治疗胰腺癌的预后分析

Prognostic analysis of robotic and open pancreatoduodenectomy for pancreatic cancer

目的探讨度过学习曲线后机器人与开腹胰十二指肠切除术治疗胰腺癌的预后。方法采用倾向评分匹配及回顾性队列研究方法。收集2017年1月至2018年12月上海交通大学医学院附属瑞金医院收治的396例行根治性胰十二指肠切除术胰腺导管腺癌患者的临床病理资料;男244例,女152例;年龄为64(36~92)岁。396例患者中,86例行机器人胰十二指肠切除术,设为机器人组;310例行开腹胰十二指肠切除术,设为开腹组。观察指标:(1)倾向评分匹配情况及匹配后两组患者一般资料比较。(2)随访情况和生存分析。采用电话或门诊方式进行随访,检查内容包括肿瘤指标和腹部影像学指标,了解患者生存情况。总生存时间定义为从手术日至死亡或末次随访时间。无病生存时间定义为手术日至肿瘤复发或末次随访时间。随访时间截至2022年3月。倾向评分匹配按1∶1最近邻匹配法匹配。Shapiro-Wilk法检验计量资料的正态性,偏态分布的计量资料以M(范围)表示,组间比较采用Mann-Whitney秩和检验。计数资料以绝对数表示,组间比较采用χ^(2)检验。采用Kaplan-Meier法计算生存率和绘制生存曲线,采用Log-Rank检验进行生存分析。采用意向治疗分析,机器人中转开腹患者归为机器人组。结果(1)倾向评分匹配情况及匹配后两组患者一般资料比较:396例患者中,164例(机器人组与开腹组各82例)配对成功。倾向评分匹配前机器人组患者体质量指数,肿瘤T分期(T1期、T2期、T3期、T4期),肿瘤N分期(N0期、N1期、N2期)分别为23.4(21.4~25.3)kg/m2,24、41、10、11例,52、27、7例;开腹组上述指标分别为22.4(20.3~23.9)kg/m2,57、144、22、87例,131、132、47例;两组患者上述指标比较,差异均有统计学意义(Z=3.01,2.63,3.03,P<0.05)。倾向评分匹配后机器人组患者性别(男),年龄,体质量指数,美国麻醉医师协会评分(1分、2分、3分),CA19-9,术前胆道引流,联合静脉切除,胰腺切缘<1 mm,肿瘤T分期(T1期、T2期、T3期、T4期),肿瘤N分期(N0期、N1期、N2期),神经侵犯,肿瘤分化程度(高中分化、中低分化、低分化),辅助化疗分别为51例,65(59~69)岁,23.0(21.0~25.2)kg/m2,32、41、9例,160.4(46.7~377.2)U/mL,21例,9例,8例,21、40、10、11例,48、27、7例,76例,26、47、9例,53例;开腹组上述指标分别为58例,65(58~69)岁,23.3(21.4~25.3)kg/m2,35、39、8例,172.0(69.7~402.9)U/mL,26例,9例,10例,24、40、7、11例,49、28、5例,76例,22、49、11例,57例;两组患者上述指标比较,差异均无统计学意义(χ^(2)=1.34,Z=0.18、0.34、0.49、0.51,χ^(2)=0.75、0.00、0.25,Z=0.59、0.27,χ^(2)=0.00,Z=0.76,χ^(2)=0.44,P>0.05)。(2)随访情况和生存分析:倾向评分匹配后164例患者均获得术后随访,随访时间为54(1~67)个月。机器人组和开腹组患者随访时间分别为55(51~59)个月和54(50~58)个月,两组比较,差异无统计学意义(Z=0.48,P>0.05)。随访期间机器人组患者1年总生存率,3年总生存率,中位总生存时间,1年无病生存率,3年无病生存率,中位无病生存时间,肿瘤复发率,肿瘤复发位置(局部复发、肝脏复发、其他远处复发、局部及远处复发)分别为81.7%,39.0%,27个月(95%可信区间为19~33个月),61.0%,34.2%,15个月(95%可信区间为12~18个月),54.9%(45/82),12、16、9、8例;开腹组上述指标分别为79.3%,36.0%,24个月(95%可信区间为19~31个月),59.8%,27.5%,15个月(95%可信区间为10~20个月),58.5%(48/82),10、22、6、10例。两组患者总生存、无病生存比较,差异均无统计学意义(χ^(2)=0.39,0.47,P>0.05)。两组患者肿瘤复发率、肿瘤复发位置比较,差异均无统计学意义(χ^(2)=0.22,1.86,P>0.05)。结论度过学习曲线后,机器人与开腹胰十二指肠切除术治疗胰腺癌预后比较差异无统计学意义。

Objective To investigate the prognosis of robotic pancreatoduodenectomy after the learning curve and open pancreatoduodenectomy for pancreatic cancer.Methods The propensity score matching and retrospective cohort study was conducted.The clinicopathological data of 396 patients who underwent curative pancreatoduodenectomy for pancreatic duct adenocar-cinoma in Ruijin Hospital of Shanghai Jiaotong University School of Medicine from January 2017 to December 2018 were collected.There were 244 males and 152 females,aged 64(range,36‒92)years.Of 396 patients,86 cases undergoing robotic pancreatoduodenectomy were divided into robotic group,310 cases undergoing open pancreatoduodenectomy were divided into open group.Observa-tion indicators:(1)propensity score matching and comparison of general data between the two groups after matching;(2)follow-up and survival analysis.Follow-up was conducted by telephone interview or outpatient examinations including tumor markers and abdominal imaging examina-tions to detect survival of patients up to March 2022.Overall survival was defined as the time from the surgery date to death or the last follow-up.Disease-free survival was defined as the time from the surgery date to tumor recurrence or the last follow-up.The propensity score matching was conducted by 1∶1 matching using the nearest neighbor method.Normality of measurement data was examined using the Shapiro-Wilk test.Measurement data with skewed distribution were described as M(range),and comparison between groups was analyzed using the Mann-Whitney rank-sum test.Count data were represented as absolute numbers,and comparison between groups was analyzed using the chi-square test.Kaplan-Meier method was used to calculate survival rates and draw survival curves,and Log-Rank test was used for survival analysis.An intent-to-treat analysis was performed in this study,patients who were converted to laparotomy from robotic surgery were still divided into the robotic group.Results(1)Propensity score matching and comparison of general data between the two groups after matching:164 of 396 patients had successful matching,including 82 cases in robotic group and open group,respectively.Before propensity score matching,the body mass index,cases in stage T1,T2,T3,T4,cases in N0,N1,N2 were 23.4(range,21.4‒25.3)kg/m^(2),24,41,10,11,52,27,7 for the robotic group,versus 22.4(range,20.3‒23.9)kg/m^(2),57,144,22,87,131,132,47 for the open group,showing significant differences in the above indicators between the two groups(Z=3.01,2.63,3.03,P<0.05).After propensity score matching,cases of males,age,body mass index,cases with American Society of Anesthesiologists(ASA)score as 1,2,3,CA19-9,cases with preoperative biliary drainage,cases with portal vein resection,cases with pancreatic resection margin<1 mm,cases in stage T1,T2,T3,T4,cases in stage N0,N1,N2,cases with nerve invasion,cases with tumor differentiation as high-medium differentiation,medium-low differentiation,low differentiation,cases with adjuvant chemotherapy were 51,65(range,59‒69)years,23.0(range,21.0‒25.2)kg/m^(2),32,41,9,160.4(range,46.7‒377.2)U/mL,21,9,8,21,40,10,11,48,27,7,76,26,47,9,53 for the robotic group,versus 58,65(range,58‒69)years,23.3(range,21.4‒25.3)kg/m^(2),35,39,8,172.0(range,69.7‒402.9)U/mL,26,9,10,24,40,7,11,49,28,5,76,22,49,11,57 for the open group,showing no significant difference in the above indicators between the two groups(χ^(2)=1.34,Z=0.18,0.34,0.49,0.51,χ^(2)=0.75,0.00,0.25,Z=0.59,0.27,χ^(2)=0.00,Z=0.76,χ^(2)=0.44,P>0.05).(2)Follow-up and survival analysis:after propensity score matching,164 patients were followed up for 54(range,1‒67)months.The follow-up time of patients was 55(range,51‒59)months for the robotic group,versus 54(range,50‒58)months for the open group,respectively,showing no significant difference between the two groups(Z=0.48,P>0.05).During the follow-up,the 1-year overall survival rate,3-year overall survival rate,the median survival time,1-year disease-free survival rate,3-year disease-free survival rate,the median disease-free survival time,tumor recurrence rate,cases with recurrence pattern as local recurrence,liver recurrence,other distant recurrence,local and distant recurrence were 81.7%,39.0%,27 months(95%confidence interval as 19‒33 months),61.0%,34.2%,15 months(95%confidence interval as 12‒18 months),54.9%(45/82),12,16,9,8 for the robotic group.The above indicators were 79.3%,36.0%,24 months(95%confidence interval as 19‒31 months),59.8%,27.5%,15 months(95%confidence interval as 10‒20 months),58.5%(48/82),10,22,6,10 for the open group.There was no significant difference in overall survival or disease-free survival between the two groups(χ^(2)=0.39,0.47,P>0.05).There was no significant difference in tumor recurrence rate or tumor recurrence site between the two groups either(χ^(2)=0.22,1.86,P>0.05).Conclusion After the learning curve,robotic pancreato-duodenectomy has non-inferior prognosis compared with open pancreatoduodenectomy.