达芬奇机器人手术系统、腹腔镜与开腹手术治疗局部进展期Siewert Ⅱ型和Ⅲ型食管胃结合部腺癌近期疗效对比研究

A comparative study on short⁃term outcomes of Da Vinci robotic versus laparoscopic and open surgery for locally advanced Siewert typeⅡandⅢadenocarcinoma of esophagogastric junction

目的探讨达芬奇机器人手术系统、腹腔镜与开腹手术治疗局部进展期SiewertⅡ型和Ⅲ型食管胃结合部腺癌的近期疗效。方法采用倾向评分匹配和回顾性队列研究方法。收集2009年1月至2019年4月陆军军医大学第一附属医院收治的404例行胃癌根治术局部进展期SiewertⅡ型和Ⅲ型食管胃结合部腺癌患者的临床病理资料;男331例,女73例;中位年龄为62岁,年龄范围为34~90岁。404例患者中,104例行达芬奇机器人手术系统胃癌根治术设为机器人组;205例行腹腔镜胃癌根治术设为腹腔镜组;95例行开腹胃癌根治术设为开腹组。观察指标:(1)倾向评分匹配情况及匹配后3组患者一般资料比较。(2)手术情况。(3)术中淋巴结清扫情况。(4)术后情况。(5)并发症情况。(6)随访情况。术后1个月采用门诊和电话方式进行随访,了解患者出院后生存和严重并发症发生情况。随访时间截至2019年6月。倾向评分匹配分析应用SPSS 23.0统计软件和R软件3.6.1 MatchIt程序对机器人组、腹腔镜组和开腹组患者进行1∶2∶1最近邻匹配法匹配。正态分布的计量资料以􀭰x±s表示,组间比较采用单因素方差分析。偏态分布的计量资料以M(范围)表示,组间比较采用Kruskal⁃Wallis H检验。等级资料比较采用Mann⁃Whitney U检验。计数资料以绝对数或百分比表示,组间比较采用χ2检验。结果(1)倾向评分匹配情况及匹配后3组患者一般资料比较:404例患者中,312例患者配对成功,其中机器人组78例,腹腔镜组156例,开腹组78例。倾向评分匹配前机器人组患者年龄,组织组织病理学分级(G1、G2、G3级),手术切除范围(近端胃、全胃)分别为(62.2±1.0)岁,0、37、67例,13、91例,腹腔镜组患者上述指标分别为(60.9±8.1)岁,0、98、107例,31、174例,开腹组患者上述指标分别为(58.5±9.8)岁,1、32、62岁,27、68例;3组患者上述指标比较,差异均有统计学意义(F=4.269,6.356,χ2=10.416,P<0.05)。经倾向评分匹配后机器人组患者上述指标分别为(61.2±10.8)岁,0、28、50例,12、66例;腹腔镜组患者上述指标分别为(60.7±8.0)岁,0、56、100例,25、131例;开腹手术组患者上述指标分别为(60.7±8.4)岁,0、25、53例,18、60例;3组上述指标比较,差异均无统计学意义(F=0.074,0.379,χ2=2.141,P>0.05)。(2)手术情况:倾向评分匹配后机器人组、腹腔镜组、开腹组患者手术时间,术中出血量,手术切口长度,近端切缘长度分别为300.0 min(188.0~420.0 min)、276.0 min(180.0~400.0 min)、244.5 min(125.0~461.0 min),137.5 mL(50.0~400.0 mL)、150.0 mL(40.0~800.0 mL)、200.0 mL(55.0~800.0 mL),6.0 cm(3.0~12.0 cm)、6.0 cm(3.0~12.0 cm)、20.0 cm(18.0~25.0 cm),2.5 cm(1.5~5.5 cm)、3.0 cm(1.0~5.0 cm)、2.0 cm(1.0~5.5 cm),3组患者上述指标比较,差异均有统计学意义(χ2=27.619,30.069,179.367,11.560,P<0.05)。(3)术中淋巴结清扫情况:倾向评分匹配后机器人组、腹腔镜组、开腹组患者淋巴结清扫总数,第一站淋巴结清扫数目,膈肌与食管周围淋巴结清扫数目分别为30.5枚(10.0~70.0枚)、29.0枚(12.0~79.0枚)、29.0枚(18.0~58.0枚),18.0枚(6.0~42.0枚)、19.0枚(6.0~47.0枚)、18.0枚(12.0~38.0枚),4.0枚(0~13.0枚)、5.0枚(0~15.0枚)、5.0枚(0~8.0枚),3组患者上述指标比较,差异均无统计学意义(χ2=3.676,1.014,0.827,P>0.05);3组患者第二站淋巴结清扫数目,胰腺上区淋巴结清扫数目,第110组淋巴结清扫数目,第111组淋巴结清扫数目分别为9.0枚(2.0~30.0枚)、6.5枚(0~25.0枚)、6.5枚(0~19.0枚),9.0枚(2.0~30.0枚)、7.0枚(0~25.0枚)、6.5枚(0~19.0枚),1.0枚(0~4.0枚)、0枚(0~3.0枚)、0枚(0~1.0枚),0枚(0~3.0枚)、0枚(0~4.0枚)、0枚(0~1.0枚),3组患者上述指标比较,差异均有统计学意义(χ2=19􀆰027,24.368,19.236,11.147,P<0.05)。(4)术后情况:倾向评分匹配后机器人组、腹腔镜组、开腹组患者术后首次肛门排气时间,术后首次下床活动时间,术后住院时间及住院费用分别为3 d(2~5 d)、3 d(2~8 d)、4 d(2~10 d),2 d(1~4 d)、2 d(1~7 d)、4 d(2~10 d),9 d(5~20 d)、9 d(6~56 d)、11 d(8~41 d),10.6万元[(5.4~18.0)万元]、8.6万元[(5.7~40.8)万元]、8.4万元[(5.8~15.2)万元],3组患者上述指标比较,差异均有统计学意义(χ2=28.487,95.069,39.443,83.899,P<0.05)。(5)并发症情况:倾向评分匹配后机器人组患者术后总体并发症发生率、严重并发症(Clavien⁃Dindo分级≥3)发生率、胃肠道相关并发症发生率、切口相关并发症发生率、呼吸系统并发症发生率、感染并发症发生率分别为21.8%(17/78)、5.1%(4/78)、10.3%(8/78)、1.3%(1/78)、7.7%(6/78)、2.6%(2/78),腹腔镜组患者上述指标分别为21.8%(34/156)、7.1%(11/156)、5.1%(8/156)、1.3%(2/156)、11.5%(18/156)、3.8%(6/156),开腹组患者上述指标分别为29.5%(23/78),6.4%(5/78)、9.0%(7/78)、2.6%(2/78)、14.1%(11/78)、2.6%(2/78),3组患者上述指标比较,差异均无统计学意义(χ2=1.913.0.321,2.394,0.866,1.641,0.335,P>0.05)。(6)随访情况:倾向评分匹配后312例患者均获得术后随访,随访时间为术后1个月。随访期间,2例患者因严重并发症自动出院后死亡,310例患者均未出现输入襻和输出襻梗阻、倾倒综合征等严重并发症。结论达芬奇机器人手术系统胃癌根治术治疗局部进展期SiewertⅡ型和Ⅲ型食管胃结合部腺癌安全可行。与腹腔镜及开腹手术比较,达芬奇机器人手术系统在第二站淋巴结清扫,尤其是胰腺上区淋巴结清扫更具优势。

Objective To investigate the short⁃term outcomes of Da Vinci robotic versus laparoscopic and open surgery for locally advanced Siewert typeⅡandⅢadenocarcinoma of esophagogastric junction(AEG).Methods The propensity score matching and retrospective cohort study was conducted.The clinicopathological data of 404 patients with locally advanced Siewert typeⅡandⅢAEG who underwent radical gastrectomy in the First Hospital Affiliated to Army Medical University from January 2009 to April 2019 were collected.There were 331 males and 73 females,aged from 34 to 90 years,with a median age of 62 years.Of the 404 patients,104 undergoing Da Vinci robotic radical gastrectomy were allocated into robotic group,205 undergoing laparoscopic radical gastrectomy were allocated into laparoscopic group,and 95 undergoing open radical gastrectomy were allocated into open group.Observation indicators:(1)the propensity score matching conditions and comparison of general data among the three groups after propensity score matching;(2)surgical situations;(3)intraoperative lymph node dissection;(4)postoperative situations;(5)postoperative complications;(6)follow⁃up.Patients were followed up at postoperative 1 month by outpatient examination and telephone interview to detect survival and severe complications up to June 2019.The propensity score matching was used to perform 1∶2∶1 nearest neighbor matching by SPSS 23.0 and R software 3.6.1 Matchit among the robotic group,laparoscopic group and open group.Measurement data with normal distribution were represented as Mean±SD,and comparison among groups was done using one⁃way ANOVA analysis.Measurement data with skewed distribution were represented as M(range),and comparison was done using the Kruskal⁃Wallis H test.Comparison of ordinal data was analyzed using the Mann⁃Whitney U test.Count data were represented as absolute numbers or percentages,and comparison among groups was done using the chi⁃square test.Results(1)The propensity score matching conditions and comparison of general data among the three groups after propensity score matching:312 of 404 patients had successful matching,including 78 in the robotic group,156 in the laparoscopic group,and 78 in the open group.The age,cases in G1,G2,G3(histopathological classification)and cases with proximal gastrectomy or total gastrectomy(surgical resection range)before matching were(62.2±1.0)years,0,37,67,13,91 in the robotic group,(60.9±8.1)years,0,98,107,31,174 in the laparoscopic group,and(58.5±9.8)years,1,32,62,27,68 in the open group,showing significant differences among the three groups(F=4.269,6.356,χ2=10.416,P<0.05).The above indicators after matching were(61.2±10.8)years,0,28,50,12,66 in the robotic group,(60.7±8.0)years,0,56,100,25,131 in the laparoscopic group,and(60.7±8.4)years,0,25,53,18,60 in the open group,showing no significant difference among the three groups(F=0.074,0.379,χ2=2.141,P>0.05).(2)Surgical situations:the surgical time,volume of intraoperative blood loss,length of surgical incision,length of proximal margin after matching were 300.0 minutes(range,188.0-420.0 minutes),137.5 mL(range,50.0-400.0 mL),6.0 cm(range,3.0-12.0 cm),2.5 cm(range,1.5-5.5 cm)in the robotic group,276.0 minutes(range,180.0-400.0 minutes),150.0 mL(range,40.0-800.0 mL),6.0 cm(range,3.0-12.0 cm),3.0 cm(range,1.0-5.0 cm)in the laparoscopic group,and 244.5 minutes(range,125.0-461.0 minutes),200.0 mL(range,55.0-800.0 mL),20.0 cm(range,18.0-25.0 cm),2.0 cm(range,1.0-5.5 cm)in the open group,showing significant differences among the three groups(χ2=27.619,30.069,179.367,11.560,P<0.05).(3)Intraoperative lymph node dissection:the number of lymph node dissected,the number of lymph node dissected in the first station,the number of diaphragmatic and periesophageal lymph node dissected were 30.5(range,10.0-70.0),18.0(range,6.0-42.0),4.0(range,0-13.0)in the robotic group,29.0(range,12.0-79.0),19.0(range,6.0-47.0),5.0(range,0-15.0)in the laparoscopic group,and 29.0(range,18.0-58.0),18.0(range,12.0-38.0),5.0(range,0-8.0)in the open group,showing no significant difference among the three groups(χ2=3.676,1.014,0.827,P>0.05).The number of lymph node dissected in the second station,the number of lymph node dissected in the superior pancreatic region,the number of No.110 lymph node dissected,the number of No.111 lymph node dissected after matching were 9.0(range,2.0-30.0),9.0(range,2.0-30.0),1.0(range,0-4.0),0(range,0-3.0)in the robotic group,6.5(range,0-25.0),7.0(range,0-25.0),0(range,0-3.0),0(range,0-4.0)in the laparoscopic group,and 6.5(range,0-19.0),6.5(range,0-19.0),0(range,0-1.0),0(range,0-1.0)in the open group,showing significant differences among the three groups(χ2=19.027,24.368,19.236,11.147,P<0.05).(4)Postoperative situations:the time to first flatus,time to initial out⁃of⁃bed activities,duration of postoperative hospital stay,treatment expenses after matching were 3 days(range,2-5 days),2 days(range,1-4 days),9 days(range,5-20 days),10.6×10^4 yuan[range,(5.4-18.0)×10^4 yuan]in the robotic group,3 days(range,2-8 days),2 days(range,1-7 days),9 days(range,6-56 days),8.6×10^4 yuan[range,(5.7-40.8)×10^4 yuan]in the laparoscopic group,and 4 days(range,2-10 days),4 days(range,2-10 days),11 days(range,8-41 days),8.4×10^4 yuan[range,(5.8-15.2)×10^4 yuan]in the open group,showing significant differences among the three groups(χ2=28.487,95.069,39.443,83.899,P<0.05).(5)Postoperative complications:the incidence of overall complications,incidence of severe complications(Clavien⁃Dindo classification≥grade 3),incidence of gastrointestinal complications,incidence of incisional complications,incidence of respiratory complications,incidence of infection were 21.8%(17/78),5.1%(4/78),10.3%(8/78),1.3%(1/78),7.7%(6/78),2.6%(2/78)in the robotic group,21.8%(34/156),7.1%(11/156),5.1%(8/156),1.3%(2/156),11.5%(18/156),3.8%(6/156)in the laparoscopic group,and 29.5%(23/78),6.4%(5/78),9.0%(7/78),2.6%(2/78),14.1%(11/78),2.6%(2/78)in the open group,showing no significant difference among the three groups(χ2=1.913,0.321,2.394,0.866,1.641,0.335,P>0.05).(6)Follow⁃up:312 patients after propensity score matching were follow up at postoperative 1 month.During the follow⁃up,2 cases with severe complications died after discharge.No severe complication such as obstruction of input or output loop,dumping syndrome was found in the other 310 patients.Conclusions The Da Vinci robotic radical gastrectomy is safe and feasible for locally advanced Siewert typeⅡandⅢAEG.Compared with laparoscopic and open radical gastrectomy,Da Vinci robotic radical gastrectomy has more advantages in the number of lymph node dissected in the second station(especially in the superior pancreatic region).