The application of non-direct vision biopsy under endoscopic retrograde cholangiopancreatography in the differential diagnosis of benign and malignant biliary strictures
Objective To explore the application value of non-direct vision biopsy under endoscopic retrograde cholangiopancreatography(ERCP)in the differential diagnosis of benign and malignant biliary strictures.Methods From January 14,2017 to June 2,2022,at the First Affiliated Hospital of Nanjing Medical University,194 patients with biliary strictures who received ERCP were retrospective selected.According to the pathological results,the diagnosis was positive(malignant),negative(benign),the suspicious(uncertain),and the suspicious was further divided into atypical and suspected malignant.Kappa consistency analysis and chi-square test were used to compare the diagnostic consistency of non-direct vision biopsy under ERCP,bile duct brushing,and simultaneous non-direct vision biopsy under ERCP and bile duct brushing.Binary logistic regression model was used to compare the relative malignant risk ratios of atypical and suspected malignant.Results A total of 189 patients successfully received non-direct vision biopsy under ERCP,the biopsy results of 88 cases were positive,30 cases were suspicious,and 71 cases was negative.Among the suspicious cases,23 cases were atypical and 7 cases were suspected malignant.A total of 148 patients underwent non-direct vision biopsy under ERCP and bile duct brushing simultaneously,the biopsy results of 18 cases were positive,69 cases were suspicious,and 61 cases were negative.Among the suspicious cases,43 cases were atypical,and 26 cases were suspected malignant.The results of Kappa test showed that the diagnostic consistency between non-direct vision biopsy under ERCP and bile duct brushing was poor(Kappa value=0.267,P＜0.001).The sensitivity of non-direct vision biopsy under ERCP was higher than that of bile duct brushing in the diagnosis of malignant biliary strictures(76.1％,67/88 vs.21.6％,19/88),and the difference was statistically significant(x2=53.39,P＜0.001),while there was no significant difference in the differential diagnosis of specificity(81.7％,49/60 vs.78.3％,47/60,P＞0.05).The diagnostic consistency between non-direct vision biopsy under ERCP and simultaneous non-direct vision biopsy under ERCP and bile duct brushing was good(Kappa value=0.821,P＜0.001).The sensitivity of simultaneous non-direct vision biopsy under ERCP and bile duct brushing in the diagnosis of malignant biliary strictures was 79.5％(70/88),and the specificity was 86.7％(52/60).There were no significant differences in sensitivity and specificity compared with non-direct vision biopsy under ERCP(both P＞0.05).In malignant bile duct stenosis diagnosis by non-direct vision biopsy under ERCP,the sensitivity,positive predictive value,and accuracy of biopsy specimens more than three were all higher than those of biopsy specimens less than or equal three(85.1％vs.67.6％,96.1％vs.78.6％,and 86.5％vs.75.3％),and the differences were statistically significant(x2=4.63,9.05 and3.92;P=0.031,0.003 and 0.048).There were no significant differences in the sensitivity,specificity,positive predictive value,negative predictive value,and accuracy in the diagnosis of malignant stenosis between biopsies of the upper and middle segments of the bile duct and the lower segment of the bile duct(all P＞0.05).In the suspicious results of non-direct vision biopsy under ERCP,take benign as a reference object,the RR(95％confidence interval,95％CI)of atypical and suspicious malignant were 7.4(2.9 to 18.8)and 12.2(5.0 to 29.9).In the suspicious results of bile duct brushing,take benign as a reference object,RR(95％CI)of atypical and suspicious malignant were 3.0(1.8 to 5.0)and 4.4(2.8 to 6.9).Conclusions The diagnostic value of non-direct vision biopsy under ERCP is superior to bile duct brushing.Increasing the number of biopsy specimens and improving operation techniques can further increase the diagnostic sensitivity of tumors.Further classification of suspicious pathological results is more beneficial for doctors to develop follow-up strategies and treatment plans.
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