海德堡三角清扫胰十二指肠切除术治疗胰头癌的临床疗效

Clinical efficacy of pancreaticoduodenectomy with TRIANGLE operation in the treatment of pancreatic head cancer

目的:探讨海德堡三角清扫胰十二指肠切除术治疗胰头癌的临床疗效。方法:采用回顾性队列研究方法。收集2017年1月至2018年7月电子科技大学附属医院四川省人民医院收治的51例胰头癌患者的临床病理资料;男33例,女18例;中位年龄为56岁,年龄范围为42~74岁。51例患者中,24例行标准胰十二指肠切除术(清扫第12、13、17组淋巴结)联合介入动脉灌注化疗(TAI),设为标准组;27例行海德堡三角清扫胰十二指肠切除术(清扫第7、8、9、12、13、16、17组淋巴结)联合TAI,设为海德堡组。观察指标:(1)两组患者术中情况比较。(2)两组患者术后情况比较。(3)随访和生存情况。采用门诊和电话方式进行随访,术后每3个月随访1次,了解患者肿瘤复发转移及生存情况。随访时间截至2021年7月或患者死亡。正态分布的计量资料以x±s表示,组间比较采用t检验;偏态分布的计量资料以M(范围)表示。计数资料以绝对数表示,组间比较采用χ^(2)检验或Fisher确切概率法。等级资料比较采用秩和检验。采用Kaplan-Meier法计算生存率和中位生存时间并绘制生存曲线,Log-Rank检验进行生存分析。结果:(1)两组患者术中情况比较。标准组患者手术时间、术中出血量、术中输血分别为(501±61)min、(563±278)mL、4例;海德堡组患者上述指标分别为(556±46)min、(489±234)mL、6例;两组患者手术时间比较,差异有统计学意义(t=3.62,P<0.05);两组患者术中出血量、术中输血比较,差异均无统计学意义(t=1.03,χ^(2)=0.25,P>0.05)。(2)两组患者术后情况比较。51例患者中,30例术后发生并发症(共50例次)。50例次总并发症中,Clavien-DindoⅠ级、Ⅱ级、Ⅲa级、Ⅲb级并发症分别为18、29、2、1例次。标准组患者术后发生并发症例数,胃排空障碍,胰瘘(无、A级、B级),胆瘘,出血,腹泻分别为15例,4例,13、7、4例,4例,2例,2例;海德堡组患者上述指标分别为15例,6例,14、10、3例,4例,1例,3例;两组患者并发症总例数、胃排空障碍、胰瘘比较,差异均无统计学意义(χ^(2)=0.16,0.02,Z=-0.04,P>0.05);两组患者胆瘘、出血、腹泻比较,差异均无统计学意义(P>0.05)。标准组和海德堡组患者Clavien‐DindoⅠ级、Ⅱ级、Ⅲ级并发症分别为10、11、2例和8、18、1例,两组比较,差异无统计学意义(Z=-0.67,P>0.05)。标准组和海德堡组患者术后住院时间均为(23±8)d,两组比较,差异无统计学意义(t=0.31,P>0.05)。(3)随访和生存情况。51例患者均获得随访,随访时间为17(6~54)个月。标准组和海德堡组患者术后1年总生存率分别为75.0%和81.5%;术后3年总生存率分别为12.5%和22.2%。标准组和海德堡组患者术后中位生存时间分别为15.00个月(95%可信区间为12.63~17.37个月)和21.00个月(95%可信区间为15.91~19.62个月),两组患者生存情况比较,差异有统计学意义(χ^(2)=4.30,P<0.05)。标准组患者1年和3年肿瘤复发例数分别为9例和20例;海德堡组患者上述指标分别为6例和15例;两组患者术后1年肿瘤复发比较,差异无统计学意义(P>0.05);两组患者术后3年肿瘤复发比较,差异有统计学意义(P<0.05)。结论:与标准胰十二指肠切除术比较,行海德堡三角清扫胰十二指肠切除术治疗胰头癌,可延长患者中位生存时间,且不增加手术相关并发症。

Objective:To investigate the clinical efficacy of pancreaticoduodenectomy with TRIANGLE operation in the treatment of pancreatic head cancer.Methods:The retrospective cohort study was conducted.The clinicopathological data of 51 patients with pancreatic head cancer who were admitted to the Sichuan Provincial People′s Hospital,Affiliated Hospital of School of Medicine of University of Electronic Science and Technology of China from January 2017 to July 2018 were collected.There were 33 males and 18 females,aged from 42 to 74 years,with a median age of 56 years.Of the 51 patients,24 cases undergoing standard pancreaticoduodenectomy,in which No.12,13 and 17 lymph nodes were dissected,combined with transcatheter arterial infusion chemo-therapy(TAI)were allocated into the standard group,and 27 cases undergoing pancreaticoduo-denectomy with TRIANGLE operation,in which No.7,8,9,12,13,16,17 lymph nodes were dissected,combined with TAI were allocated into the TRIANGLE group,respectively.Observation indicators:(1)intraoperative conditions of the two groups;(2)postoperative conditions of the two groups;(3)follow-up and survival.Follow-up was conducted using outpatient examination and telephone interview once three months to detect tumor recurrence and metastasis and survival of patients up to July 2021 or the death of patient.Measurement data with normal distribution were represented as Mean±SD,and comparison between groups was analyzed using the t test.Measurement data with skewed distribution were represented as M(range),and comparison between groups was analyzed using the chi-square test or the Fisher exact probability.Comparison of ordinal data was analyzed using the rank sum test.Kaplan‐Meier method was used to calculate the survival rate and median survival time and draw survival curve.Log‐Rank test was used for survival analysis.Results:(1)Comparison of intraoperative conditions between the two groups.The operation time,volume of intraoperative blood loss,cases with intraoperative blood transfusion were(501±61)minutes,(563±278)mL,4 in the standard group,versus(556±46)minutes,(489±234)mL,6 in the TRIANGLE group,respectively.There was a significant difference in the operation time between the two groups(t=3.62,P<0.05)but there was no significant difference in the volume of intraoperative blood loss or cases with intraoperative blood transfusion between the two groups(t=1.03,χ^(2)=0.25,P>0.05).(2)Comparison of postoperative conditions between the two groups.Of the 51 patients,30 had 50 times of postoperative complications,including 18 times of gradeⅠcomplications of Clavien-Dindo classification,29 times of gradeⅡcomplications of Clavien-Dindo classification,2 times of gradeⅢa complications of Clavien-Dindo classification,1 time of gradeⅢb complications of Clavien-Dindo classification,respectively.Cases with postoperative complications,cases with delayed gastric emptying,cases without or with pancreatic fistula as class A or class B,cases with biliary fistula,cases with bleeding,cases with diarrhea were 15,4,13,7,4,4,2,2 in the standard group,versus 15,6,14,10,3,4,1,3 in the TRIANGLE group,respectively.There was no significant difference in cases with postoperative complications,cases with delayed gastric emptying,cases with pancreatic fistula between the two groups(χ^(2)=0.16,0.02,Z=-0.04,P>0.05)and there was no significant difference in cases with biliary fistula,cases with bleeding,cases with diarrhea between the two groups(P>0.05).Cases with complications as Clavien-Dindo gradeⅠ,gradeⅡ,gradeⅢwere 10,11,2 in the standard group,versus 8,18,1 in the TRIANGLE group,showing no significant difference between the two groups(Z=-0.67,P>0.05).The duration of postoperative hospital stay was(23±8)days in both of the standard group and the TRIANGLE group,showing no significant difference between the two groups(t=0.31,P>0.05).(3)Follow-up and survival.All the 51 patients were followed-up for 6 to 54 months,with a median follow-up time of 17 months.The postoperative 1-year overall survival rate was 75.0%and 81.5%in the standard group and the TRIANGLE group,respectively.The postoperative 3-year overall survival rate was 12.5%and 22.2%in the standard group and the TRIANGLE group,respectively.The median postoperative survival time was 15.00 months(95%confidence interval as 12.63 to 17.37 months)and 21.00 months(95%confidence interval as 15.91 to 19.62 months)in the standard group and the TRIANGLE group,respectively.There was a significant difference in survival of patients between the two groups(χ^(2)=4.30,P<0.05).Cases with tumor recurrence during post-operative 1 year and 3 year were 9 and 20 in the standard group,versus 6 and 15 in the TRIANGLE group,respectively.There was no significant difference in cases with tumor recurrence during postoperative 1 year between the two groups(P>0.05)and there was a significant difference in cases with tumor recurrence during postoperative 3 year between the two groups(P<0.05).Conclusion:Compared with standard pancreaticoduodenectomy,pancreaticoduodenectomy with TRIANGLE operation can prolong the median survival time of patients with pancreatic head cancer without increasing surgical related complications.