A Clinical Study Of A New Scoring System Based On The Tokyo Guidelines To Direct Acute Cholangitis In Urgent Drainage

AimsTo assess the predictive power of Tokyo guidelines(TG)18/13 and TG07 for the urgent drainage of acute cholangitis(AC)and establish a new scoring system that could be a supplement to the guidelines described above.MethodsA total of 197 patients diagnosed with AC were retrospectively examined in this study.8 patients died during hospitalization and the remaining 189 patients were observed in this clinical study,including 91 patients in the derivation group from May 30,2015 to December 31,2017 and 98 patients in the validation group from January 1,2018 to June 15,2019 at Shandong Qianfoshan Hospital,Cheeloo College of Medicine,Shandong University.According to the biliary drainage time of patients in the derivation group and the validation group,the patients who received drainage within 24h after admission were divided into urgent drainage group,and the remaining patients were divided into nonurgent drainage group.The methods of biliary drainage in this study mainly include endoscopic retrograde cholangiopancreatography(ERCP),percutaneous transhepatic biliary drainage(PTBD)and surgery.The patient data were collected through the hospital information system.In the study,the time interval from admission to urgent drainage was considered as the dependent variable,while a series of factors such as clinical characteristics and laboratory test results were considered as the independent variables.Univariate and multivariate logistic regression analyses were used to select the significant risk factors,then used the significant risk factors to establish a new scoring system.The receiver operator characteristic(ROC)curve and the z-test were used to estimate the specificity of different evaluation systems.The Kaplan-Meier survival analysis was used to further validate the clinical value of the combination of the new scoring system with TG18/13.In this retrospective study,we only conducted clinical analysis and did not participate in clinical decision-makingResultsThrough univariate analysis,the following five factors were found to be statistically significant in validation group:total bilirubin(HR 1.212,95%CI 1.022-1.438,P=0.027),direct bilirubin(HR 1.265,95%CI 1.010-1.584,P=0.041),platelet count(HR 0.989,95%CI 0.978-0.999,P=0.038),serum albumin(HR 0.862,95%CI 0.762-0.976,P=0.019),Charcot's triad(HR 19.800 95%CI 3.094-126.714,P=0.002).Incorporated the above five factors into multivariate analysis and found one factor associated with acute drainage:Charcot's triad(HR 19.800 95%CI 3.094-126.714,P=0.002).The ROC curve was used to calculate the cut-off values for continuous variables.According to the results above,a new scoring system was established with a maximum score of 6 points.Four factors were assigned 1 point including platelet count<170.0*109/L,serum albumin<25.1 g/dL,total bilirubin>3.13 mg/dL,and direct bilirubin>0.81 mg/dL.Additionally,Charcot's triad would be assigned 2 points.According to the results of the ROC curve,point 2.5 served as a cut-off value,and urgent drainage was considered beneficial among patients who received points greater than or equal to 3.0.In order to evaluate the guiding significance of each system for urgent drainage,we performed ROC curve analysis.Among patients whose length of hospital stay was less than the median length of hospital stay in the validation group,the results of the ROC curve indicated that combination of TG18/13 and the new scoring system had a higher sensitivity and approximate specificity than both TG07 and TG18/13 in assessing the necessity of urgent drainage.The area under the curve(AUC)of the new scoring system in the ROC curve was 0.765(95%CI 0.584-0.946),the AUC of TG07 was 0.697(95%CI 0.508-0.887)and the AUC of TG18/13 was 0.781(95%CI 0.610-0.952),which were all significantly less than the AUC of the combination of the new scoring system with TG18/13(P<0.001 vs.TG07 and P=0.038 vs.TG18/13).To further validate the clinical value of the combination of new scoring system and TG18/13,survival analysis was conducted among all validation group patients.Patients with a positive indication in either TG18/13(grade ?/?)or the combination of the new scoring system with TG18/13(new scoring system points?3.0 or TG18/13 grade ?/?)would benefit from urgent drainage,expressed as a shorter length of hospital stay.In addition,patients with a positive indication in the combination of the new scoring system with TG18/13 would expect to have a greater benefit than that of patients with a positive indication in TG18/13 alone(P=0.003,?2=8.907 vs.P=-0.008,?2=6.969).ConclusionsConsidering the rapid progress and the serious consequences of acute cholangitis,urgent drainage at the right time is of great significance to its therapeutic effects.Through this study,we identified the predictive value of TG18/13 for urgent drainage was better than that for TG07 and established a new scoring system as a supplement to TG18/13.