江苏省胰十二指肠切除手术情况和预后分析(附2886例报告)

Analysis of surgical situations and prognosis of pancreaticoduodenectomy in Jiangsu province(a report of 2886 cases)

目的探讨江苏省开展胰十二指肠切除术的手术情况和围手术期结局,分析术后90 d死亡的影响因素。方法采用回顾性病例对照研究方法。收集2021年3月至2022年12月江苏省胰腺专病质量控制中心中南京医科大学第一附属医院等21家大型三甲医院收治的2886例行胰十二指肠切除术患者的临床病理资料;男1732例,女1154例;年龄为65(57,71)岁。江苏省胰腺专病质量控制中心在江苏省胰腺疾病质量控制项目的框架之下,采用多中心注册登记研究方法,建立全省统一胰十二指肠切除电子数据库。观察指标:(1)临床特征。(2)术中和术后情况。(3)胰十二指肠切除术后90 d内死亡的影响因素分析。偏态分布的计量资料以M(Q1,Q3)或M(IQR)表示,组间比较采用Mann⁃Whitney U检验。计数资料以绝对数或构成比表示,组间比较采用χ^(2)检验、χ^(2)检验连续性校正、Fisher确切概率法。约登指数最大值确定连续变量最佳分界值。单因素分析根据数据类型采用对应的统计学方法。多因素分析采用Logistic多元回归模型。结果(1)临床特征。2886例行胰十二指肠切除术患者中,2021年和2022年分别为1175例和1711例。21家医院中,8家胰十二指肠切除术年均手术量<36例,10家年均手术量为36~119例,3家年均手术量≥120例。年均手术量≥36例的13家医院施行胰十二指肠切除术2584例,占总数89.536%(2584/2886);年均手术量≥120例的3家医院施行胰十二指肠切除术1357例,占总数47.020%(1357/2886)。(2)术中和术后情况。2886例患者中,手术入路为开腹2397例、微创488例、未知1例;保留幽门情况为保留871例、未保留1952例、未知63例;联合脏器切除情况为联合任何脏器切除305例(含血管切除209例)、未联合脏器切除2579例、未知2例。2885例手术时间为290(115)min,2882例术中出血量为240(250)mL,2880例术中输血率27.153%(782/2880)。2886例患者中,侵入性治疗率为11.342%(327/2883)、非计划重症监护室治疗率为3.087%(89/2883)、再次手术率为1.590%(45/2830),术后住院时间为17(11)d,住院死亡率为0.798%(23/2882),2083例有严重并发症资料的挽救失败率为6.529%(19/291)。2477例患者获得术后90 d随访,术后90 d病死率为2.705%(67/2477)。2886例患者术后并发症情况,总并发症发生率为58.997%(1423/2412),严重并发症发生率为13.970%(291/2083),2078例综合并发症指数为8.7(22.6)。(3)胰十二指肠切除术后90 d内死亡的影响因素分析。多因素分析结果显示:年龄≥70岁、术后侵入性治疗、术后非计划重症监护室治疗是胰十二指肠切除术后90 d内死亡的独立危险因素(优势比=2.403,2.609,16.141,95%可信区间为1.281~4.510,1.298~5.244,7.119~36.596,P<0.05);医院年均手术量≥36例是胰十二指肠切除术后90 d内死亡的独立保护因素(优势比=0.368,95%可信区间为0.168~0.808,P<0.05)。结论江苏省胰十二指肠切除术在部分医院高度集中,术后并发症发生率高,术后90 d死亡风险显著高于住院死亡风险。年龄≥70岁、术后侵入性治疗、术后非计划重症监护室治疗是胰十二指肠切除术后90 d死亡的独立危险因素;医院年均手术量≥36例是术后90 d死亡的独立保护因素。

Objective To investigate the surgical situations and perioperative outcome of pancreaticoduodenectomy in Jiangsu Province and the influencing factors for postoperative 90-day mortality.Methods The retrospective case-control study was conducted.The clinicopathological data of 2886 patients who underwent pancreaticoduodenectomy in 21 large tertiary hospitals of Jiangsu Quality Control Center for Pancreatic Diseases,including The First Affiliated Hospital of Nanjing Medical University,from March 2021 to December 2022 were collected.There were 1732 males and 1154 females,aged 65(57,71)years.Under the framework of the Jiangsu Provincial Pancreatic Disease Quality Control Project,the Jiangsu Quality Control Center for Pancreatic Diseases adopted a multi-center registration research method to establish a provincial electronic database for pancreaticoduodenectomy.Observation indicators:(1)clinical characteristics;(2)intraoperative and postoperative conditions;(3)influencing factors for 90-day mortality after pancreaticoduodenectomy.Measurement data with skewed distribution were represented as M(Q1,Q3)or M(IQR),and comparison between groups was conducted using the Mann-Whitney U test.Count data were expressed as absolute numbers or constituent ratio,and comparison between groups was conducted using the chi-square test,continuity correction chi-square test and Fisher exact probability.Maximal Youden index method was used to determine the cutoff value of continuous variables.Univariate analysis was performed using the corresponding statistical methods based on data types.Multivariate analysis was performed using the Logistic multiple regression model.Results(1)Clinical characteristics.Of the 2886 patients who underwent pancreaticoduodenectomy,there were 1175 and 1711 cases in 2021 and 2022,respectively.Of the 21 hospitals,8 hospitals had an average annual surgical volume of<36 cases for pancreaticoduodenectomy,10 hospitals had an average annual surgical volume of 36−119 cases,and 3 hospitals had an average annual surgical volume of>120 cases.There were 2584 cases performed pancreaticoduodenectomy in thirteen hospitals with an average annual surgical volume of≥36 cases,accounting for 89.536%(2584/2886)of the total cases.There were 1357 cases performed pancreaticoduodenectomy in three hospitals with an average annual surgical volume of≥120 cases,accounting for 47.020%(1357/2886)of the total cases.(2)Intraoperative and postoperative conditions.Of the 2886 patients,the surgical approach was open surgery in 2397 cases,minimally invasive surgery in 488 cases,and it is unknown in 1 case.The pylorus was preserved in 871 cases,not preserved in 1952 cases,and it is unknown in 63 cases.Combined organ resection was performed in 305 cases(including vascular resection in 209 cases),not combined organ resection in 2579 cases,and it is unknown in 2 cases.The operation time of 2885 patients was 290(115)minutes,the volume of intraoperative blood loss of 2882 patients was 240(250)mL,and the intraoperative blood transfusion rate of 2880 patients was 27.153%(782/2880).Of the 2886 patients,the invasive treatment rate was 11.342%(327/2883),the unplanned Intensive Care Unit(ICU)treatment rate was 3.087%(89/2883),the reoperation rate was 1.590%(45/2830),the duration of postoperative hospital stay was 17(11)days,the hospitalization mortality rate was 0.798%(23/2882),and the failure rate of rescue data in 2083 cases with severe complications was 6.529%(19/291).There were 2477 patients receiving postoperative 90-day follow-up,with the 90-day mortality of 2.705%(67/2477).The total incidence rate of complication in 2886 patients was 58.997%(1423/2412).The incidence rate of severe complication was 13.970%(291/2083).The comprehensive complication index was 8.7(22.6)in 2078 patients.(3)Influencing factors for 90-day mortality after pancreaticoduodenectomy.Results of multivariate analysis showed that age≥70 years,postoperative invasive treatment,and unplanned ICU treatment were independent risk factors for 90-day mortality after pancreaticoduodenectomy(odds ratio=2.403,2.609,16.141,95%confidence interval as 1.281−4.510,1.298−5.244,7.119−36.596,P<0.05).Average annual surgical volume≥36 cases in the hospital was an independent protective factor for 90-day mortality after pancreaticoduodenectomy(odds ratio=0.368,95%confidence interval as 0.168−0.808,P<0.05).Conclusions Pancreaticoduodenectomy in Jiangsu Province is highly concentrated in some hospitals,with a high incidence of postoperative complications,and the risk of postoperative 90-day mortality is significant higher than that of hospitallization mortality.Age≥70 years,postoperative invasive treatment,and unplanned ICU treatment are independent risk factors for 90-day motality after pancreaticoduodenectomy,and average annual surgical volume≥36 cases in the hospital is an independent protective factor.