Diagnostic Value Of Peptidase Inhibitor 15 In Bile For Cholangiocarcinoma

Background and Aim:Cholangiocarcinoma is a common malignant tumor with high malignancy and poor prognosis.Because it is difficult to obtain pathology,clinical diagnosis mainly depends on imaging examination,and the diagnosis lacks specific markers.Recent studies have confirmed that peptidase inhibitor 15 in blood has certain significance in the diagnosis of cholangiocarcinoma.This study aims to explore whether peptidase inhibitor 15 in bile has value in the diagnosis of cholangiocarcinoma.Method:Patients with biliary tract diseases admitted to the First Affiliated Hospital of Dalian Medical University from September 2018 to January 2021 were preliminarily treated as suspected patients with cholangiocarcinoma and patients with benign biliary tract diseases by ultrasound,abdominal CT,upper abdominal MRI+MRCP,endoscopic ultrasonography and other relevant examinations before or after admission.Bile samples were gathered during endoscopic operation.Bile samples were stored in-80℃refrigerator.According to the blood test,ultrasound,abdominal CT,upper abdominal MRI+MRCP,intraoperative cholangiography,endoscopic ultrasonography,peroral cholangio-pancreatoscopy and postoperative pathology,the clinical diagnosis was made.According to the strict inclusion and exclusion criteria,the bile of patients was divided into the cancer group and the benign biliary group,namely experimental group and control group.There were 8 patients in the experimental group and 28 patients with benign biliary diseases(8 patients with choledocholithiasis and cholangitis,8 patients with choledocholithiasis and cholecystitis,8 patients with choledocholithiasis and 4 patients with benign biliary stricture)in the control group.Serum related indicators were extracted from prospective hospital clinical database.Peptidase inhibitor 15 in bile were measured by enzyme-linked immunosorbent assay.We measured CA19-9,CA125 and CEA by the way of electrochemiluminescence.The serum related indexes(Carbohydrate antigen 19-9,Carbohydrate antigen125 and Carcinoembryonic antigen,Alkaline phosphatase,Gamma glutamyltransferase,Total bilirubin)and bile tumor markers(Serum carbohydrate antigen 19-9,Carbohydrate antigen 125,Carcinoembryonic antigen,Peptidase inhibitor 15)were collected and statistical analysed.Results:1.There was no significant difference in pi 15 between cholangiocarcinoma group and choledocholithiasis combined with acute cholangitis group.After adjusting the inclusion criteria(excluding choledocholithiasis combined with cholangitis),the clinical information of malignant group and benign group were compared,And the Gender(P=0.566),Bile CA19-9(P=0.566),CA125(P=0.05)of cholangiocarcinoma group and benign disease group were compared.There was no significant difference in Age(73.5 vs 61.8,P=0.033),Serum CA19-9(425.06 vs 72.23u/ml,P=0.013),CA125(41.38 vs 11.46u/ml,P=0.011),CEA(18.81 vs 1.72ng/ml,P=0.011),ALP(511.63 vs 174.65iu/l,P<0.001),γ-GT(833.63 vs 394.9iu/l,P=0.038),TBIL(223.44 vs 40.03umol/l,P<0.001),Bile CE A(112.56 vs.37.02 ng/ml,P=0.007)and PI15(504.25 vs.380.80 ng/ml,P=0.010<0.05),The differences were statistically significant,and they were higher than benign group.2.Univariate logistic regression analysis showed that serum CEA(P=0.041,standard error=0.508),Serum ALP(P=0.008,standard error=0.005),Serum TBIL(P=0.016,standard error=0.013)and Bile PI15(P=0.012,standard error=0.012)were significantly correlated with the occurrence of cholangiocarcinoma..3.The area under the ROC curve of serum CEA was 0.806,the cutoff value was 2.83ng/ml(CI 95%0.627-0.986),The area under the curve of serum ALP was 0.912,the cutoff value was 480iu/L(CI 95%0.796-1.000).The area under the curve of serum TBIL was 0.944,the cutoff value was 75umol/L(CI 95%0.986)The area under the curve of pi 15 in bile was 0.894,and the cutoff value was 442ng/ml(CI 95%0.738-1.000).4.By comparing the ROC curve,it was found that the ROC curve of serum CEA was statistically different from that of serum CEA combined with serum TBIL,which indicated that in the diagnosis of biliary system diseases,a single tumor marker may not have enough diagnostic efficiency in the diagnosis of malignant diseases.And it has higher diagnostic value in combination with other liver function indicators such as TBIL.Conclusion:Peptidase inhibitor 15 has limited efficacy in the differential diagnosis of benign and malignant biliary diseases.Combined detection of serum CEA has higher diagnostic value for cholangiocarcinoma.