Department of Gastroenterological Endoscopy, the First Affiliated Hospital of Dalian Medical University, 222 Zhongshan road, Xigang district, Dalian, 116011, Liaoning Province, China.
Department of Clinical Laboratory, the First Affiliated Hospital of Dalian Medical University, Dalian, 116011, Liaoning Province, China.
BMC Gastroenterol. 2020 Apr 20;20(1):118. doi: 10.1186/s12876-020-01254-7.
To evaluate the value of the 3-h post-ERCP serum amylase level for early prediction of post-ERCP pancreatitis (PEP).
A study of 206 patients performed ERCP (Encoscopic Retrograde Cholangio-Pancreatography) at a single centre was done from Jan. 2011 to Nov. 2016. The serum amylase or lipase level was measured at 3 h after ERCP. The patients with PEP were recorded. ROC curves were used to statistically analyze the data: The enrolled patients were divided into two groups according to gender, then we analyzed the data respectively. We comprehensively evaluated the predictive value of PEP by 3-h post-ERCP serum amylase level based on the results above.
Two hundred six patients (92 males, 114 females) were enrolled. PEP occurred in 21 patients (10.19%) among them. The median time to discharge was 7 days (min = 1d, max = 13d) after the procedure. In the 206 patients, the 3-h post-ERCP pancreatic amylase level was used as the test variable, and the PEP occurrence as the state variable to plot the ROC curve. The area under the curve (AUC) was 0.816, and was statistically significant (P < 0.001). The standard error (SE) was 0.0507, the 95% confidence interval (CI) was 0.756-0.866, and the optimal cut-off value was 351 U/L (sensitivity 76.19%, specificity 83.24%, positive likelihood ratio 4.55, negative likelihood ratio 0.29, Youden index 59.43%). Of the 206 patients, there were 83 patients with both 3-h post-ERCP amylase level and lipase level detected, and the ROC curves were plotted for both serum amylase and lipase respectively. The ROC curve matched-pair testing was carried out: The areas under the ROC curves were statistically significant. (P < 0.001) The area under the ROC curve for the 3-h post-ERCP lipase was 0.778, the 95% confidence interval was 0.673-0.862, and optimal cut-off value was 1834 U/L. The area under the ROC curve for the 3-h post-ERCP serum amylase was 0.780, and the 95% confidence interval was 0.676-0.864. The optimal cut-off is 380 U/L, and there was no statistically significant difference between the two for diagnostic accuracy. According to gender, 206 patients were divided into 2 groups, and the ROC curves were drawn respectively. Based on statistical analysis, there was no statistically significant difference in the diagnostic accuracy of the two groups. In the male group, 436 U/L serum amylase provided the greatest diagnostic accuracy with sensitivity (SE) of 70.5%, specificity (SP) of 89.2%, positive predictive value (PPV) 87.5%, and negative predictive value (NPV) 78.1%. Whereas, in the female group, 357 U/L serum amylase provided the greatest diagnostic accuracy with sensitivity of 76.9%, specificity of 81.2%, positive predictive value of 80.4%, negative predictive value of 77.9%.
评估 3 小时经内镜逆行胰胆管造影(ERCP)后血清淀粉酶水平对预测 ERCP 后胰腺炎(PEP)的价值。
对 2011 年 1 月至 2016 年 11 月在一家中心进行的 206 例 ERCP 患者进行了研究。在 ERCP 后 3 小时测量血清淀粉酶或脂肪酶水平。记录发生 PEP 的患者。使用 ROC 曲线对数据进行统计学分析:根据性别将入组患者分为两组,然后分别进行分析。根据上述结果,综合评估 3 小时经内镜逆行胰胆管造影后血清淀粉酶水平对 PEP 的预测价值。
共纳入 206 例患者(92 例男性,114 例女性)。其中 21 例(10.19%)发生 PEP。术后中位数出院时间为 7 天(min=1d,max=13d)。在 206 例患者中,将 3 小时经内镜逆行胰胆管造影后胰淀粉酶水平作为检验变量,PEP 发生作为状态变量绘制 ROC 曲线。曲线下面积(AUC)为 0.816,差异有统计学意义(P<0.001)。标准误差(SE)为 0.0507,95%置信区间(CI)为 0.756-0.866,最佳截断值为 351U/L(灵敏度 76.19%,特异性 83.24%,阳性似然比 4.55,阴性似然比 0.29,约登指数 59.43%)。在 206 例患者中,有 83 例同时检测了 3 小时经内镜逆行胰胆管造影后血清淀粉酶和脂肪酶水平,分别绘制了两种血清酶的 ROC 曲线。对 ROC 曲线进行配对检验:ROC 曲线下面积差异有统计学意义(P<0.001)。3 小时经内镜逆行胰胆管造影后血清脂肪酶的 ROC 曲线下面积为 0.778,95%置信区间为 0.673-0.862,最佳截断值为 1834U/L。3 小时经内镜逆行胰胆管造影后血清淀粉酶的 ROC 曲线下面积为 0.780,95%置信区间为 0.676-0.864,最佳截断值为 380U/L,两种方法对诊断准确性的差异无统计学意义。根据性别将 206 例患者分为两组,分别绘制 ROC 曲线。经统计学分析,两组的诊断准确性无统计学差异。在男性组中,血清淀粉酶 436U/L 时诊断准确性最高,灵敏度(SE)为 70.5%,特异性(SP)为 89.2%,阳性预测值(PPV)为 87.5%,阴性预测值(NPV)为 78.1%。而在女性组中,血清淀粉酶 357U/L 时诊断准确性最高,灵敏度为 76.9%,特异性为 81.2%,阳性预测值为 80.4%,阴性预测值为 77.9%。