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题名中国胆囊癌流行病学特征与诊治及预后分析（附6 159例报告）
其他题名Epidemiological characteristics, diagnosis, treatment and prognosis of gallbladder cancer in China: a report of 6 159 cases
作者
发表日期2022
发表期刊中华消化外科杂志   影响因子和分区
语种中文
原始文献类型学术期刊
关键词胆道肿瘤 术前诊断 外科治疗 辅助治疗 流行病学 影响因素 预后
其他关键词Biliary tract neoplasms ; Preoperative diagnosis ; Surgical treatment ; Adju-vant treatment ; Epidemiology ; Influencing factor ; Prognosis
摘要目的探讨2010—2017年中国胆囊癌临床流行病学特征、诊断、治疗与预后情况。方法采用单病种回顾性登记队列研究方法。基于"真实世界研究"理念, 收集2010年1月至2017年12月中国胆囊癌研究小组(CRGGC)建立的中国胆囊癌多中心回顾性临床资料数据库中42家医院收治的6 159例胆囊癌患者的临床病理资料。观察指标:(1)病例来源情况。(2)年龄与性别分布情况。(3)诊断情况。(4)外科治疗与预后情况。(5)综合治疗与预后情况。随访数据由CRGGC对各协作中心的临床随访数据进行收集整理, 主要结局指标为手术治疗患者手术之日或未手术患者确诊之日起, 至结局事件发生或随访截至时间的总体生存时间。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(Q1, Q3)或M(范围)表示, 组间比较采用U检验。计数资料以绝对数和(或)百分比表示, 组间比较采用χ2检验。单因素分析采用强迫引入Logistic回归模型, 将P<0.1的因素引入多因素分析。多因素分析采用逐步后退Logistic回归模型。采用寿命表法计算生存率, 采用Kaplan-Meier法绘制生存曲线, 采用Log-rank检验进行生存分析。结果 (1)病例来源情况:42家医院中, 三级甲等医院35家, 三级乙等医院7家;胆囊癌收治高流量医院16家, 非高流量医院26家。42家医院地域分布:中部地区9家, 东北地区5家, 东部地区22家, 西部地区6家。6 159例患者地域分布:2 154例(34.973%)来自中部地区, 705例(11.447%)来自东北地区, 1 969例(31.969%)来自东部地区, 1 331例(21.611%)来自西部地区。6 159例患者总体院均诊断与治疗数为(18.3±4.5)例/年;其中4 974例(80.760%)来源于高流量医院, 院均诊断与治疗患者数为(38.8±8.9)例/年;1 185例(19.240%)来源于非高流量医院, 院均诊断与治疗患者数为(5.7±1.9)例/年。(2)年龄与性别分布情况:6 159例患者确诊年龄为64(56, 71)岁;其中男性2 247例(36.483%), 确诊年龄为64(58, 71)岁;女性3 912例(63.517%), 确诊年龄为63(55, 71)岁。性别比例为女性:男性=1.74∶1。3 886例(63.095%)患者确诊年龄为56～75岁。不同性别患者确诊年龄比较, 差异有统计学意义(Z=-3.99, P<0.001)。(3)诊断情况:6 159例患者中, 初步诊断为胆囊癌2 503例(40.640%), 初步诊断非胆囊癌3 656例(59.360%)。未手术患者2 110例(34.259%), 其中初步诊断为胆囊癌200例(9.479%), 初步诊断为非胆囊癌1 910例(90.521%)。手术患者4 049例(65.741%), 其中初步诊断为胆囊癌2 303例(56.878%), 初步诊断为非胆囊癌1 746例(43.122%)[术中诊断为胆囊癌774例(19.116%)、术后诊断为胆囊癌972例(24.006%)]。6 159例患者中, 初步诊断前行超声、CT、磁共振成像(MRI)检查分别为2 521例(40.932%)、2 335例(37.912%)、1 114例(18.087%), 行血清癌胚抗原(CEA)、CA19-9、CA125检测分别为3 259例(52.914%)、3 172例(51.502%)、4 016例(65.205%)。同一例患者可行多种检查。单因素分析结果显示:来源医院地区(东部地区、西部地区), 年龄(≥72岁), 收治医院胆囊癌患者流量, 初步诊断前超声检查, 初步诊断前CT检查, 初步诊断前MRI检查, 初步诊断前CEA检测, 初步诊断前血清CA19-9检测, 初步诊断前血清CA125检测均是影响胆囊癌患者初步诊断为胆囊癌的相关因素(优势比=1.45、1.98, 0.69, 0.68, 2.43, 0.41, 1.63, 0.41, 0.39, 0.42, 95%可信区间为1.21～1.74、1.64～2.40, 0.59～0.80, 0.60～0.78, 2.19～2.70, 0.37～0.45, 1.43～1.86, 0.37～0.45, 0.35～0.43, 0.38～0.47, P<0.05)。多因素分析结果显示:来源医院地区(东部地区、西部地区), 性别, 年龄(≥72岁), 收治医院胆囊癌患者流量, 初步诊断前超声检查, 初步诊断前CT检查, 初步诊断前血清CA19-9检测是影响胆囊癌患者初步诊断为胆囊癌的独立影响因素(优势比=1.36、1.42, 0.89, 0.67, 1.85, 1.56, 1.57, 0.39, 95%可信区间为1.13～1.64、1.16～1.73, 0.79～0.99, 0.57～0.78, 1.60～2.14, 1.38～1.77, 1.38～1.79, 0.35～0.43, P<0.05)。(4)外科治疗与预后情况:4 049例手术治疗患者中, 2 447例(60.435%)分期资料和随访资料完整, 0期、Ⅰ期、Ⅱ期、Ⅲa期、Ⅲb期、Ⅳa期、Ⅳb期分别为85例(3.474%)、201例(8.214%)、71例(2.902%)、890例(36.371%)、382例(15.611%)、33例(1.348%)、785例(32.080%)。2 447例患者中位随访时间为55.75个月(95%可信区间为52.78～58.35), 术后总体中位生存时间为23.46个月(95%可信区间为21.23～25.71)。0期、Ⅰ期、Ⅱ期、Ⅲa期、Ⅲb期、Ⅳa期、Ⅳb期患者总体生存情况比较, 差异有统计学意义(χ2=512.47, P<0.001)。4 049例手术治疗患者中, 可切除性肿瘤2 988例(73.796%), 不可切除性肿瘤177例(4.371%), 可切除性无法评估884例(21.833%)。2 988例可切除性肿瘤患者中, 根治性切除2 036例(68.139%), 非根治性切除504例(16.867%), 手术根治性无法评估448例(14.994%)。2 447例分期和随访资料完整的手术治疗患者中, 不可切除性肿瘤53例(2.166%), 可切除性肿瘤非根治性切除300例(12.260%), 可切除性肿瘤根治性切除1 441例(58.888%), 无法评估653例(26.686%)。733例未手术患者随访资料完整。未手术、不可切除性肿瘤手术治疗、可切除性肿瘤非根治性切除、可切除性肿瘤根治性切除患者总体生存情况比较, 差异有统计学意义(χ2=121.04, P<0.001)。(5)综合治疗与预后情况:6 159例患者中, 541例(8.784%)行术后辅助化疗和晚期化疗, 76例(1.234%)行放疗。1 170例进展期(Ⅲa期及以上)行根治性切除手术患者中, 联合术后辅助化疗126例(10.769%), 未联合术后辅助化疗1 044例(89.231%), 两者总体生存情况比较, 差异无统计学意义(χ2=0.23, P=0.629)。658例Ⅲa期行根治性切除手术患者中, 联合术后辅助化疗66例(10.030%), 未联合术后辅助化疗592例(89.970%), 两者总体生存情况比较, 差异无统计学意义(χ2=0.05, P=0.817)。512例≥Ⅲb期行根治性切除手术患者中, 联合术后辅助化疗60例(11.719%), 未联合术后辅助化疗452例(88.281%), 两者总体生存情况比较, 差异无统计学意义(χ2=1.50, P=0.220)。结论我国胆囊癌患者女性多于男性, 超过半数确诊年龄为56～75岁。初步诊断前行超声和CT检查、血清CA19-9检测是初步诊断胆囊癌的独立影响因素, 基于术前可切除性评估可改进治疗决策、改善患者预后。我国胆囊癌辅助化疗尚不规范且比例较低。
其他摘要Objective:To investigate the epidemiological characteristics, diagnosis, treat-ment and prognosis of gallbladder cancer in China from 2010 to 2017.Methods:The single disease retrospective registration cohort study was conducted. Based on the concept of the real world study, the clinicopathological data, from multicenter retrospective clinical data database of gallbladder cancer of Chinese Research Group of Gallbladder Cancer (CRGGC), of 6 159 patients with gallbladder cancer who were admitted to 42 hospitals from January 2010 to December 2017 were collected. Observation indicators: (1) case resources; (2) age and sex distribution; (3) diagnosis; (4) surgical treatment and prognosis; (5) multimodality therapy and prognosis. The follow-up data of the 42 hospitals were collected and analyzed by the CRGGC. The main outcome indicator was the overall survival time from date of operation for surgical patients or date of diagnosis for non-surgical patients to the end of outcome event or the last follow-up. Measurement data with normal distribu-tion were represented as Mean±SD, and comparison between groups was conducted using the t test. Measurement data with skewed distribution were represented as M( Q1, Q3) or M(range), and com-parison between groups was conducted using the U test. Count data were described as absolute numbers or percentages, and comparison between groups was conducted using the chi-square test. Univariate analysis was performed using the Logistic forced regression model, and variables with P<0.1 in the univariate analysis were included for multivariate analysis. Multivariate analysis was performed using the Logistic stepwise regression model. The life table method was used to calculate survival rates and the Kaplan-Meier method was used to draw survival curves. Log-rank test was used for survival analysis. Results:(1) Case resources: of the 42 hospitals, there were 35 class A of tertiary hospitals and 7 class B of tertiary hospitals, 16 hospitals with high admission of gallbladder cancer and 26 hospitals with low admission of gallbladder cancer, respectively. Geographical distribution of the 42 hospitals: there were 9 hospitals in central China, 5 hospitals in northeast China, 22 hospitals in eastern China and 6 hospitals in western China. Geographical distribution of the 6 159 patients: there were 2 154 cases(34.973%) from central China, 705 cases(11.447%) from northeast China, 1 969 cases(31.969%) from eastern China and 1 331 cases(21.611%) from western China. The total average number of cases undergoing diagnosis and treatment in hospitals of the 6 159 patients was 18.3±4.5 per year, in which the average number of cases undergoing diagnosis and treatment in hospitals of 4 974 patients(80.760%) from hospitals with high admission of gallbladder cancer was 38.8±8.9 per year and the average number of cases undergoing diagnosis and treatment in hospitals of 1 185 patients(19.240%) from hospitals with low admission of gallbladder cancer was 5.7±1.9 per year. (2) Age and sex distribution: the age of 6 159 patients diagnosed as gallbladder cancer was 64(56,71) years, in which the age of 2 247 male patients(36.483%) diagnosed as gallbladder cancer was 64(58,71)years and the age of 3 912 female patients(63.517%) diagnosed as gallbladder cancer was 63(55,71)years. The sex ratio of female to male was 1.74:1. Of 6 159 patients, 3 886 cases(63.095%) were diagnosed as gallbladder cancer at 56 to 75 years old. There was a significant difference on age at diagnosis between male and female patients ( Z=-3.99, P<0.001). (3) Diagnosis: of 6 159 patients, 2 503 cases(40.640%) were initially diagnosed as gallbladder cancer and 3 656 cases(59.360%) were initially diagnosed as non-gallbladder cancer. There were 2 110 patients(34.259%) not undergoing surgical treatment, of which 200 cases(9.479%) were initially diagnosed as gallbladder cancer and 1 910 cases(90.521%) were initially diagnosed as non-gallbladder cancer. There were 4 049 patients(65.741%) undergoing surgical treatment, of which 2 303 cases(56.878%) were initially diagnosed as gallbladder cancer and 1 746 cases(43.122%) were initial diagnosed as non-gallbladder cancer. Of the 1 746 patients who were initially diagnosed as non-gallbladder cancer, there were 774 cases(19.116%) diagnosed as gallbladder cancer during operation and 972 cases(24.006%) diagnosed as gallbladder cancer after operation. Of 6 159 patients, there were 2 521 cases(40.932%), 2 335 cases(37.912%) and 1 114 cases(18.087%) undergoing ultrasound, computed tomography (CT) or magnetic resonance imaging (MRI) examination before initial diagnosis, respec-tively, and there were 3 259 cases(52.914%), 3 172 cases(51.502%) and 4 016 cases(65.205%) undergoing serum carcinoembryonic antigen, CA19-9 or CA125 examination before initially diagnosis, respectively. One patient may underwent multiple examinations. Results of univariate analysis showed that geographical distribution of hospitals (eastern China or western China), age ≥72 years, gallbladder cancer annual admission of hospitals, whether undergoing ultrasound, CT, MRI, serum carcinoembryonic antigen, CA19-9 or CA125 examination before initially diagnosis were related factors influencing initial diagnosis of gallbladder cancer patients ( odds ratio=1.45, 1.98, 0.69, 0.68, 2.43, 0.41, 1.63, 0.41, 0.39, 0.42, 95% confidence interval as 1.21-1.74, 1.64-2.40, 0.59-0.80, 0.60-0.78, 2.19-2.70, 0.37-0.45, 1.43-1.86, 0.37-0.45, 0.35-0.43, 0.38-0.47, P<0.05). Results of multivariate analysis showed that geographical distribution of hospitals (eastern China or western China), sex, age ≥72 years, gallbladder cancer annual admission of hospitals and cases undergoing ultrasound, CT, serum CA19-9 examination before initially diagnosis were indepen-dent influencing factors influencing initial diagnosis of gallbladder cancer patients ( odds ratio=1.36, 1.42, 0.89, 0.67, 1.85, 1.56, 1.57, 0.39, 95% confidence interval as 1.13-1.64, 1.16-1.73, 0.79-0.99, 0.57-0.78, 1.60-2.14, 1.38-1.77, 1.38-1.79, 0.35-0.43, P<0.05). (4) Surgical treatment and prognosis. Of the 4 049 patients undergoing surgical treatment, there were 2 447 cases(60.435%) with complete pathological staging data and follow-up data. Cases with pathological staging as stage 0, stage Ⅰ, stage Ⅱ, stage Ⅲa, stage Ⅲb, stage Ⅳa and stage Ⅳb were 85(3.474%), 201(8.214%), 71(2.902%), 890(36.371%), 382(15.611%), 33(1.348%) and 785(32.080%), respectively. The median follow-up time and median postoperative overall survival time of the 2 447 cases were 55.75 months (95% confidence interval as 52.78-58.35) and 23.46 months (95% confidence interval as 21.23-25.71), respectively. There was a significant difference in the overall survival between cases with pathological staging as stage 0, stage Ⅰ, stage Ⅱ, stage Ⅲa, stage Ⅲb, stage Ⅳa and stage Ⅳb ( χ2=512.47, P<0.001). Of the 4 049 patients undergoing surgical treatment, there were 2 988 cases(73.796%) with resectable tumor, 177 cases(4.371%) with unresectable tumor and 884 cases(21.833%) with tumor unassessable for resectabi-lity. Of the 2 988 cases with resectable tumor, there were 2 036 cases(68.139%) undergoing radical resection, 504 cases(16.867%) undergoing non-radical resection and 448 cases(14.994%) with operation unassessable for curative effect. Of the 2 447 cases with complete pathological staging data and follow-up data who underwent surgical treatment, there were 53 cases(2.166%) with unresectable tumor, 300 cases(12.260%) with resectable tumor and receiving non-radical resection, 1 441 cases(58.888%) with resectable tumor and receiving radical resection, 653 cases(26.686%) with resectable tumor and receiving operation unassessable for curative effect. There were 733 cases not undergoing surgical treatment with complete pathological staging data and follow-up data. There was a significant difference in the overall survival between cases not undergoing surgical treatment, cases undergoing surgical treatment for unresectable tumor, cases undergoing non-radical resection for resectable tumor and cases undergoing radical resection for resectable tumor ( χ2=121.04, P<0.001). (5) Multimodality therapy and prognosis: of 6 159 patients, there were 541 cases(8.784%) under-going postoperative adjuvant chemotherapy and advanced chemotherapy, 76 cases(1.234%) under-going radiotherapy. There were 1 170 advanced gallbladder cancer (pathological staging ≥stage Ⅲa) patients undergoing radical resection, including 126 cases(10.769%) with post-operative adjuvant chemotherapy and 1 044 cases(89.231%) without postoperative adjuvant chemo-therapy. There was no significant difference in the overall survival between cases with post-operative adjuvant chemotherapy and cases without postoperative adjuvant chemotherapy ( χ2=0.23, P=0.629). There were 658 patients with pathological staging as stage Ⅲa who underwent radical resection, including 66 cases(10.030%) with postoperative adjuvant chemotherapy and 592 cases(89.970%) without postoperative adjuvant chemotherapy. There was no significant difference in the overall survival between cases with postoperative adjuvant chemotherapy and cases without postoperative adjuvant chemotherapy ( χ2=0.05, P=0.817). There were 512 patients with pathological staging ≥stage Ⅲb who underwent radical resection, including 60 cases(11.719%) with postoperative adjuvant chemotherapy and 452 cases(88.281%) without postoperative adjuvant chemotherapy. There was no significant difference in the overall survival between cases with postoperative adjuvant chemo-therapy and cases without post-operative adjuvant chemo-therapy ( χ2=1.50, P=0.220). Conclusions:There are more women than men with gallbladder cancer in China and more than half of patients are diagnosed at the age of 56 to 75 years. Cases undergoing ultrasound, CT, serum CA19-9 examination before initial diagnosis are independent influencing factors influencing initial diagnosis of gallbladder cancer patients. Preoperative resectability evaluation can improve the therapy strategy and patient prognosis. Adjuvant chemotherapy for gallbladder cancer is not standardized and in low proportion in China.
资助项目国家自然科学基金（3213000192,81874181,2019XH004）;上海市科委项目（YDZX20193100004049,20JC1419101）;重大新药创制科技重大专项（2019ZX09301-158）;申康新兴前沿项目（SHDC12018107）;上海交通大学医学院多中心临床研究项目（DLY201507,15ZH4003）
ISSN1673-9752
卷号21期号:01页码:114-128
DOI10.3760/cma.j.cn115610-20220103-00004
页数15
收录类别CNKI ; 万方 ; SCOPUS ; 维普 ; 北大核心 ; ISTIC ; CSCD ; PKU
URL查看原文
SCOPUSEID2-s2.0-85132785879
维普分类号R735.8
CN号11-5610/R
引用统计
文献类型期刊论文
条目标识符https://kms.wmu.edu.cn/handle/3ETUA0LF/53577
专题温州医科大学
作者单位
1.上海交通大学医学院附属仁济医院胆胰外科 上海市肿瘤研究所 癌基因及相关基因国家重点实验室 上海市胆道疾病研究重点实验室;
2.上海交通大学医学院附属新华医院普通外科;
3.中国科学技术大学附属第一医院(安徽省立医院)肝胆外科;
4.安徽医科大学第一附属医院肝胆胰外科;
5.常熟市第一人民医院普外科;
6.常州市中医医院肿瘤科;
7.哈尔滨医科大学附属第二医院胆胰外科;
8.哈尔滨医科大学附属第一医院肝胆胰腺外科;
9.哈尔滨医科大学附属肿瘤医院肝胆胰外科;
10.海军军医大学第二附属医院(上海长征医院)普通外科四科;
11.海军军医大学东方肝胆外科医院胆道一科;
12.海南省人民医院肝脏外科;
13.湖南师范大学附属第一医院(湖南省人民医院)肝胆外科;
14.吉林大学中日联谊医院新民院区肝胆外科;
15.江西省人民医院肝胆外科;
16.江西省肿瘤医院腹部肿瘤外科;
17.空军军医大学西京医院肝胆胰脾外科;
18.昆明医科大学第一附属医院胃肠外科;
19.兰州大学第一医院普通外科五科;
20.南昌大学第一附属医院急诊科;
21.南京医科大学附属常州第二人民医院肝胆胰外科;
22.南通市肿瘤医院肝胆外科;
23.青岛大学附属医院肝胆胰外科;
24.青海省人民医院普通外科;
25.山东第一医科大学附属省立医院(山东省立医院)器官移植肝胆外二科;
26.山西省肿瘤医院普通外科一病区;
27.山西医科大学第一医院普通外科;
28.上海交通大学附属第六人民医院南院 上海市奉贤区中心医院普通外科;
29.上海交通大学附属第一人民医院普通外科;
30.上海交通大学医学院附属新华医院崇明分院普通外科;
31.上海市浦东医院普外科;
32.上海中医药大学附属普陀医院普通外科;
33.绍兴第二医院全科医学科;
34.台州市立医院肝胆外科;
35.太仓市第一人民医院胃肠外科;
36.天津市肿瘤医院胰腺肿瘤科;
37.温州医科大学附属第一医院肝胆胰外科;
38.无锡市第二人民医院肝胆外科;
39.西安交通大学第一附属医院肝胆外科;
40.新疆医科大学第一附属医院胰腺外科;
41.徐州市中心医院肝胆胰脾外科;
42.长治医学院附属和平医院肝胆外科;
43.中国医科大学附属盛京医院肝胆脾外科;
44.大连医科大学附属大连市友谊医院肝胆外科;
45.浙江大学医学院附属第二医院肝胆胰外科
推荐引用方式
GB/T 7714		 孙旭恒,王一钧,张薇,等. 中国胆囊癌流行病学特征与诊治及预后分析（附6 159例报告）[J]. 中华消化外科杂志,2022,21(01):114-128.
APA 孙旭恒., 王一钧., 张薇., 耿亚军., 李永盛., ... & 刘颖斌. (2022). 中国胆囊癌流行病学特征与诊治及预后分析（附6 159例报告）. 中华消化外科杂志, 21(01), 114-128.
MLA 孙旭恒,et al."中国胆囊癌流行病学特征与诊治及预后分析（附6 159例报告）".中华消化外科杂志 21.01(2022):114-128.

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