胆囊癌根治术中淋巴结清扫数目与预后关系的多中心临床研究  

Analysis of the relationship between the number of lymph nodes examined and prognosis for curatively resected gallbladder carcinoma:a multi-institutional study

作　　者：张瑞[1] 吴予涵 张东[1] 张永杰 邱应和 杨宁 宋天强[4] 楼健颖[5] 李江涛[5] 毛先海[6] 李升平[7] 司书宾[2] 蔡志强[2] 陈晨[1] 耿智敏[1] 汤朝晖[8] Zhang Rui;Wu Yuhan;Zhang Dong;Zhang Yongjie;Qiu Yinghe;Yang Ning;Song Tianqiang;Lou Jianying;Li Jiangtao;Mao Xianhai;Li Shengping;Si Shubin;Cai Zhiqiang;Chen Chen;Geng Zhimin;Tang Zhaohui(Department of Hepatobiliary Surgery,the First Affiliated Hospital of Xi′an Jiaotong University,Xi′an 710061,China;Department of Industrial Engineering,School of Mechanical Engineering,Northwestern Polytechnical University,Xi′an 710072,China;Department of Biliary Surgery,Eastern Hepatobiliary Surgery Hospital,Affiliated to Naval Medical University,Shanghai 200433,China;Department of Hepatobiliary Oncology,Tianjin Medical University Cancer Hospital,Tianjin 300060,China;Department of Hepatobiliary and Pancreatic Surgery,the Second Affiliated Hospital of Zhejiang University School of Medicine,Hangzhou 310009,China;Department of Hepatobiliary Surgery,Hunan Provincial People′s Hospital,Changsha 410005,China;Department of Hepatobiliary Oncology,Sun Yat-sen University Cancer Center,Guangzhou 510060,China;Department of General Surgery,Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine,Shanghai 200092,China)

机构地区：[1]西安交通大学第一附属医院肝胆外科,710061 [2]西北工业大学机电学院工业工程系,西安710072 [3]海军军医大学东方肝胆外科医院胆道外科,上海200433 [4]天津医科大学肿瘤医院肝胆肿瘤科,300060 [5]浙江大学医学院附属第二医院肝胆胰外科,杭州310009 [6]湖南省人民医院肝胆外科,长沙410005 [7]中山大学肿瘤防治中心肝胆科,广州510060 [8]上海交通大学医学院附属新华医院普通外科,200092

出　　处：《中华外科杂志》2020年第4期303-309,共7页Chinese Journal of Surgery

基　　金：陕西省重点研发计划(2017ZDXM-SF-055);西安交通大学第一附属医院临床研究基金(XJTUlAF-CRF-2018-022);上海交通大学医学院多中心临床研究项目(DLY201807);上海交通大学医学院附属新华医院院级临床研究培育基金项目(17CSK06)。

摘　　要：目的 探讨胆囊癌根治术中淋巴结清扫数目对患者预后的影响。方法 回顾性分析2013年1月至2017年12月中国6家医疗中心收治的401例行意向性根治性手术的胆囊癌患者的临床病理学资料和随访资料。其中男性153例(38.2%),女性248例(61.8%),年龄(62.0±10.5)岁(范围:30~88岁)。53例(22.2%)患者术前伴有黄疸症状。所有患者均接受意向性根治性切除+区域淋巴结清扫,术后病理学检查结果证实为R0或R1切除。采用X-tile软件以不同淋巴结清扫数目作为截断值,分组进行统计检验,分析不同截断值与预后的关系,寻找最佳截断值。生存分析采用Kaplan-Meier法,单因素预后分析采用Log-rank检验,多因素预后分析采用Cox比例风险模型。结果 401例胆囊癌患者中,135例(33.6%)伴有淋巴结转移,其中N1期98例(24.4%),N2期37例(9.2%)。共清扫2 794枚淋巴结,每例患者淋巴结清扫数目[M(QR)]为6(5)枚,阳性淋巴结数目为0(1)枚,阳性淋巴结比例为0(0.20)。X-tile软件分析结果显示,淋巴结清扫数目12枚和15枚为两个界值,据此将全部患者按淋巴结清扫数目分为1~11枚、12~15枚、≥16枚三组,3年累积生存率分别为45.2%、74.5%、12.0%,三组间差异有统计学意义(χ2=10.94,P<0.01)。多因素分析结果显示,淋巴结清扫数目是胆囊癌患者的独立预后因素(P<0.05)。不同T分期分析结果显示,T1b期患者淋巴结清扫数目1~7枚组患者预后优于≥8枚组(χ2=4.610,P<0.05);T2期患者淋巴结清扫数目≥7枚组患者预后优于1~6枚组(χ2=4.287,P<0.05);T3+T4期患者淋巴结清扫数目12~15枚组患者预后优于1~11枚组(χ2=5.007,P<0.05)及≥16枚组(χ2=10.158,P<0.01)。结论 淋巴结清扫数目是胆囊癌意向性根治性切除术后患者的独立预后因素。T1b期患者推荐清扫<8枚淋巴结;T2期患者清扫>6枚淋巴结能改善患者预后;T3期以上患者推荐清扫12~15枚淋巴结,清扫≥16枚淋巴结不能改善预后。Objective To examine the role of the number of lymph nodes examined(NLNE)on the prognosis of patients with curatively resected gallbladder carcinoma(GBC).Methods The clinicopathological data and prognosis of 401 patients with GBC who underwent radical surgery from six institutions of China from January 2013 to December 2017 were analyzed retrospectively.There were 153 males(38.2%)and 248 females(61.8%),with age of(62.0±10.5)years(range:30-88 years).Fifty-three patients(22.2%)were accompanied by jaundice.All patients underwent radical resection+regional lymphadenectomy.R0 or R1 resection was confirmed by postoperative pathological examination.The different cut-off values of NLNE were determined by the X-tile software,the optimal cut-off values were identified by analyzing the relationship between different cut-off values of NLNE with survival rate.Kaplan-Meier method was used for survival analysis.Univariate and multivariate analysis were implemented respectively using the Log-rank test and Cox proportional hazard model.Results Among the 401 patients enrolled,135 cases(33.6%)had lymphatic metastasis,of which 98 cases were in N1 stage(24.4%)and 37 cases were in N2 stage(9.2%).A total of 2794 NLNE were retrieved,with a median count of 6(5).The median positive lymph nodes count was 0(1),and the median positive lymph nodes ratio was 0(IQR,0-0.2).Since the 12 and 15 were determined as the cut-off values by X-tile,all patients were divided into three groups of 1-11,12-15 and≥16.The 3-year survival rate of the three groups was 45.2%,74.5%,12.0%respectively,with statistically significant difference between three groups(χ2=10.94,P<0.01).The results of multivariate analysis showed that NLNE was an independent prognostic factor for overall survival(P<0.05).Further analysis was performed specifically for subgroup of T stages.For T1b patients,the prognosis of the NLNE with 1-7 group was significantly better than that of the≥8 group(χ2=4.610,P<0.05).For T2 patients,the prognosis of the TLNE≥7 group was significantly be

关 键 词：胆囊肿瘤 淋巴转移 淋巴结清扫数目 预后 

分 类 号：R735[医药卫生—肿瘤]