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胰十二指肠切除术后胰瘘风险预测模型的建立: 基于2016新版胰瘘定义及分级系统

余俊 任超逸 崔巍 时静祥

引用本文:
Citation:

胰十二指肠切除术后胰瘘风险预测模型的建立: 基于2016新版胰瘘定义及分级系统

DOI: 10.12449/JCH240421
基金项目: 

天津市卫生健康科技项目 (TJWJ2023MS016)

利益冲突声明:本文不存在任何利益冲突。
作者贡献声明:余俊负责数据收集、设计论文框架、起草论文;任超逸负责数据收集、统计学分析、绘制图表;崔巍负责数据收集、研究过程的实施;时静祥负责拟定写作思路、指导撰写文章、修改论文并最后定稿。
详细信息
    通信作者:

    时静祥, 18002180065@163.com (ORCID: 0000-0002-8999-4480)

Establishment of a risk prediction model for pancreatic fistula after pancreaticoduodenectomy: A study based on the 2016 edition of the definition and classification system of pancreatic fistula

Research funding: 

Tianjin Health Research Project (TJWJ2023MS016)

More Information
    Corresponding author: SHI Jingxiang, 18002180065@163.com (ORCID: 0000-0002-8999-4480)
  • 摘要:   目的  比较分析2005版、2016版胰瘘定义及分级标准导致的胰十二指肠切除术(PD)术后胰瘘危险因素的差异,根据2016版胰瘘标准建立胰瘘风险预测模型。  方法  回顾性分析天津市第三中心医院2016年1月—2022年5月收治的303例行PD患者的临床资料,根据新、旧版胰瘘标准统计术后胰瘘患者,计量资料组间比较采用成组t检验或非参数检验Mann-Whitney U检验;计数资料组间比较采用χ2检验。单因素及多因素Logistic回归分析筛选两版标准对PD患者术后胰瘘的危险因素的区别,基于2016新版标准建立术后胰瘘的风险预测模型,受试者工作特征曲线分析该模型预测术后胰瘘发生的准确性并验证该模型。  结果  2005版胰瘘标准:单因素分析显示主胰管直径(χ2=31.641,P<0.001)、主胰管指数(χ2=52.777,P<0.001)、门静脉侵犯(χ2=6.259,P=0.012)、腹腔内脂肪厚度(χ2=7.665,P=0.006)、术前胆道引流(χ2=5.999,P=0.014)、胰腺癌(χ2=5.544,P=0.019)、切缘胰腺厚度(t=2.055,P=0.032)、胰腺CT值(t=-3.224,P=0.002)、术前血淀粉酶水平(Z=-2.099,P=0.036)与术后胰瘘的发生相关,Logistic回归分析显示主胰管指数[OR(95%CI)=0.000(0.000~0.011)]、胰腺癌[OR(95%CI)=4.843(1.285~18.254)]、胰腺CT值[OR(95%CI)=0.869(0.806~0.937)]为独立危险因素(P值均<0.05);而基于2016版胰瘘标准:单因素分析显示主胰管直径(χ2=5.391,P=0.020)、主胰管指数(χ2=11.394,P=0.001)、腹腔内脂肪厚度(χ2=8.899,P=0.003)、胰腺切缘厚度(t=2.665,P=0.009)、胰腺CT值(t=-2.835,P=0.004)与术后胰瘘的发生相关,Logistic回归分析显示主胰管指数[OR(95%CI)=0.001(0.000~0.050)]、胰腺CT值[OR(95%CI)=0.943(0.894~0.994)]为独立危险因素(P值均<0.05)。据此建立PD术后胰瘘风险预测模型,受试者工作特征曲线分析表明该模型预测PD术后胰瘘的曲线下面积在建模组与验证组分别为0.788(95%CI:0.707~0.870)和0.804(95%CI:0.675~0.932)。  结论  主胰管指数、胰腺CT值与PD术后胰瘘的发生密切相关,基于2016新版胰瘘标准建立的胰瘘风险预测模型具有较好的预测性能。

     

  • 图  1  胰瘘预测模型预测PD术后胰瘘发生的ROC曲线

    Figure  1.  ROC curve of the prediction model for pancreatic fistula after PD

    图  2  在验证组中胰瘘预测模型预测PD术后胰瘘发生的ROC曲线

    Figure  2.  ROC curve of the prediction model for pancreatic fistula after PD in validation set

    表  1  2005版与2016版术后胰瘘定义与分级系统比较

    Table  1.   Comparison of definition and grading system for POPF between 2005 and 2016

    2005年ISGPF版术后胰瘘定义与分级系统
    分级 临床表现 特殊治疗 超声或CT 持续引流>3周 二次手术 胰瘘相关死亡 感染征象 脓毒症 再入院
    A级 良好 阴性
    B级 通常良好 有/无 阴性/阳性 通常有 有/无
    C级 病容/差 阳性 可能有 有/无
    2016年ISGPS版术后胰瘘定义与分级系统
    定义及分级 术后第3天引流液的淀粉酶数值达正常上限的3倍以上 胰周持续引流>3周 临床相关的胰瘘治疗措施改变 经皮或内镜下穿刺引流 血管造影介入治疗术后胰瘘相关出血 二次手术 术后胰瘘相关的感染征象 术后胰瘘相关器官衰竭 术后胰瘘相关死亡
    生化漏
    B级 有(无器官衰竭)
    C级
    下载: 导出CSV

    表  2  建模组与验证组患者的临床特征比较

    Table  2.   Clinical characteristics of the modeling and validation sets

    指标 建模组(n=253) 验证组(n=50) P
    性别[例(%)] 0.416
    167(66.0) 30(60.0)
    86(34.0) 20(40.0)
    年龄(岁) 61±9 62±7 0.686
    BMI(kg/m2 23.1±2.7 22.4±3.3 0.312
    饮酒[例(%)] 0.246
    48(19.0) 13(26.0)
    205(81.0) 37(74.0)
    吸烟[例(%)] 0.846
    110(43.5) 21(42.0)
    143(56.5) 29(58.0)
    糖尿病[例(%)] 0.983
    56(22.1) 11(22.0)
    197(77.9) 39(78.0)
    主胰管直径(mm) 3.8±2.1 3.7±2.2 0.606
    切缘胰腺厚度(mm) 15.3±3.5 14.7±3.1 0.220
    主胰管指数 0.3±0.2 0.3±0.2 0.885
    门静脉受侵犯[例(%)] 0.901
    16(6.3) 4(8.0)
    237(93.7) 46(92.0)
    腹腔内脂肪厚度(mm) 71.1±27.2 68.3±25.3 0.389
    胰腺CT值(HU) 38.6±8.3 38.1±8.8 0.693
    术前胆道引流[例(%)] 0.707
    30(11.9) 5(10.0)
    223(88.1) 45(90.0)
    术前实验室检查
    白细胞(×109/L) 6.1±1.7 5.9±1.6 0.397
    血小板(×109/L) 232.5±68.5 240.3±62.8 0.316
    白蛋白(g/L) 39.3±4.1 38.7±3.8 0.662
    总胆红素(μmol/L) 121.3(34.1~231.4) 130.5(39.2~190.0) 0.747
    血清淀粉酶(IU/L) 25.0(16.0~42.0) 26.0(19.5~39.3) 0.737
    CA19-9(U/mL) 81.9(34.2~273.1) 94.0(28.5~357.5) 0.626
    胰肠吻合方式[例(%)] 0.814
    胰管空肠黏膜对黏膜 47(18.6) 10(20.0)
    胰肠端侧套入式 206(81.4) 40(80.0)
    胰腺癌[例(%)] 0.684
    59(23.3) 13(26.0)
    194(76.7) 37(74.0)
    术后胰瘘[例(%)]
    2005版ISGPF 0.517
    124(49.0) 22(44.0)
    129(51.0) 28(56.0)
    2016版ISGPS 0.987
    61(24.1) 12(24.0)
    192(75.9) 38(76.0)
    手术相关死亡[例(%)] 0.658
    8(3.2) 1(2.0)
    245(96.8) 49(98.0)
    下载: 导出CSV

    表  3  与PD术后胰瘘相关危险因素单因素分析结果(2005版ISGPF)

    Table  3.   Univariate analysis results of risk factors related to POPF after PD (2005 ISGPF edition)

    指标 PD术后胰瘘 统计值 P
    主胰管直径(例) χ2=31.641 <0.001
    ≤3 mm 88 46
    >3 mm 36 83
    主胰管指数(例) χ2=52.777 <0.001
    ≤0.25 101 47
    >0.25 23 82
    门静脉受侵犯(例) χ2=6.259 0.012
    3 13
    121 116
    腹腔内脂肪厚度(例) χ2=7.665 0.006
    ≤65 mm 43 67
    >65 mm 81 62
    术前胆道引流(例) χ2=5.999 0.014
    21 9
    103 120
    胰腺癌(例) χ2=5.544 0.019
    21 38
    103 91
    切缘胰腺厚度(mm) 16.5±3.7 15.0±3.8 t=2.055 0.032
    胰腺CT值(HU) 36.3±6.4 41.1±9.6 t=-3.224 0.002
    性别(例) χ2=0.572 0.449
    79 88
    45 41
    饮酒(例) χ2=1.242 0.265
    27 21
    97 108
    吸烟(例) χ2=0.001 0.974
    54 56
    70 73
    糖尿病(例) χ2=0.549 0.459
    25 31
    99 98
    胰肠吻合方式(例) χ2=1.703 0.192
    胰管空肠黏膜对黏膜 19 28
    胰肠端侧套入式 105 101
    年龄(岁) 61±9 61±7 t=-0.259 0.796
    BMI(kg/m2 23.0±3.1 23.2±2.8 t=-0.372 0.626
    术前实验室检查
    白细胞(×109/L) 6.1±1.9 6.0±1.6 t=0.773 0.441
    血小板(×109/L) 230.4±69.6 235.0±64.1 t=-0.892 0.374
    白蛋白(g/L) 39.4±4.2 38.9±4.1 t=0.757 0.450
    总胆红素(μmol/L) 124.8(55.6~249.3) 117.8(37.0~219.1) U=-1.093 0.275
    CA19-9(U/mL) 73.3(29.4~222.6) 96.2(42.0~370.1) U=-1.069 0.285
    血清淀粉酶(IU/L) 23.0(17.0~34.0) 31.5(17.3~60.0) U=-2.099 0.036
    下载: 导出CSV

    表  4  与PD术后胰瘘相关危险因素单因素分析结果(2016版ISGPS)

    Table  4.   Univariate analysis results of risk factors related to POPF after PD (2016 ISGPS edition)

    指标 PD术后胰瘘 统计值 P
    主胰管直径(例) χ2=5.391 0.020
    ≤3 mm 39 90
    >3 mm 22 102
    主胰管指数(例) χ2=11.394 0.001
    ≤0.25 47 101
    >0.25 14 91
    腹腔内脂肪厚度(例) χ2=8.899 0.003
    ≤65 mm 16 92
    >65 mm 45 100
    切缘胰腺厚度(mm) 17.0±4.2 14.5±3.6 t=2.665 0.009
    胰腺CT值(HU) 36.2±7.3 39.7±8.8 t=-2.835 0.004
    门静脉受侵犯(例) χ2=0.672 0.412
    2 14
    59 178
    术前胆道引流(例) χ2=2.933 0.087
    11 19
    50 173
    胰腺癌(例) χ2=1.721 0.190
    18 41
    43 151
    性别(例) χ2=0.720 0.396
    43 124
    18 68
    饮酒(例) χ2=0.286 0.593
    13 35
    48 157
    吸烟(例) χ2=0.020 0.887
    27 83
    34 109
    糖尿病(例) χ2=0.283 0.595
    12 44
    49 148
    胰肠吻合方式(例) χ2=2.680 0.102
    胰管空肠黏膜对黏膜 7 40
    胰肠端侧套入式 54 152
    年龄(岁) 61±8 60±10 t=1.246 0.215
    BMI(kg/m2 22.9±4.3 23.3±2.1 t=-0.738 0.534
    术前实验室检查
    白细胞(×109/L) 6.2±2.3 6.0±1.7 t=0.474 0.673
    血小板(×109/L) 230.9±67.9 237.8±73.2 t=-0.523 0.602
    白蛋白(g/L) 39.2±4.3 39.0±4.0 t=0.303 0.762
    总胆红素(μmol/L) 127.1(50.0~231.4) 121.5(32.9~216.6) U=-0.882 0.378
    CA19-9(U/mL) 97.4(34.5~314.4) 80.9(27.3~344.3) U=-0.498 0.618
    血清淀粉酶(IU/L) 24.0(17.0~33.8) 30.0(17.0~58.0) U=-1.818 0.069
    下载: 导出CSV

    表  5  与PD术后胰瘘相关危险因素多因素Logistic分析结果

    Table  5.   Multivariate analysis results of risk factors related to POPF after PD

    指标 系数 OR值(95%CI P
    2005版ISGPF
    常量 6.248 517.032 <0.001
    主胰管指数 -8.045 0.000(0.000~0.011) <0.001
    是否胰腺癌 1.578 4.843(1.285~18.254) 0.020
    胰腺CT值 -0.141 0.869(0.806~0.937) <0.001
    2016版ISGPS
    常量 2.667 14.393 0.018
    主胰管指数 -6.995 0.001(0.000~0.050) 0.001
    胰腺CT值 -0.059 0.943(0.894~0.994) 0.029
    下载: 导出CSV
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