| Backgrounds and aimsStricture lesion is a common disorder of bile duct. Cholangiocarcinoma, which is hard to distinguish from the benign for their periductal-infiltrating and slow growing char-acters, is the main cause of the malignant strictures. Routine tests, including ultra-sound, CT, MRI/MRCP, are barely used to determine the final diagnosis because of low level of discernment. Histologic confirmation of the biliary malignancy provides limited diagnostic accuracy,with especialy low sensitivity. Many patients are misdi-agnosed as benign and thus miss the surgery opportunity, while some undergo unnec-essary, high-risk surgeries.Confocal laser endomicroscopy(CLE) is an emerging endoscopic diagnostic technol-ogy, which can provide real-time, in vivo histological information by imaging of gas-trointestinal mucosa, and presents high clinical application value on the detection of early digestive cancer. Appearance of mini probe-based CLE(pCLE) further expands its scope to the cholangiopancreatic disease.Main purposes of the present reaseach are to(1)evaluate the feasibility of pCLE for biliary stricture; (2)determine the diagnostic efficiency of pCLE for biliary stricture; (3)assess the interobserver agreement of pro-posed biliary pCLE criterior.Methods Patients with indeterminate biliary stictures to endoscopic center of Qilu Hospital of Shandong University for ERCP and pCLE examination from January 2014 to January 2015 were recruited into our study.CLE vedios from 10 (8 malignant and 2 benign) patients with determined diagnosis,combined with previous literatures and pathology of cholangiocarcinoma, were analyzed to form new classifications of normal bile duct, inflammatory lesion and malignant lesion.Signs of malignant lesion were composed of thick black bands(>40μm),thick white bands(>20μm), irregular dark cluster and irregular glandular epethilial structure. pCLE appearance were graded from 0 to 4 with each malignant scoring one point. In prospective research, all the patients un-derwent ERCP guided pCLE examination and brush cytology succesively. Scores for pCLE were graded in line with the above classification,and cytology results were also gathered and recorded. Sensitivity, specificity, positive predictive value, negtive pre-dictive value and overall accuracy of pCLE for malignant biliary sticture were ana-lyzed in subgroups according to the their scores, and the criteria with best diagnostic value was then derived. Analysis of diagnostic capability between pCLE with the new proposed criteria and brush cytology was made. Interobserver agreement of the new proposed pCLE criteria was also evaluated.Results1.Twenty-five patients finished the whole study with 14 male and 11 female,42 video clips of pCLE were colected, among which 36(85.7%) clips were interpretable. Six-teen patients were diagnosed as malignant,14 were determined by cytology or sur-gery(4 of which were perihilar cholangiocarcinoma,8 were cholangiocarcinoma from the common bile ducts and 2 were pancreatic head cancer).Nine patients were be-nign,including 6 inflammatory bile stricture,2 chronic pancreatitis and 1 primary sclerosing cholangitis.No serious complications appeared to patients except transient icterus caused by fluorescin.2.When patients with pCLE videos containing any two or more malignant signs was diagnosed to be malignant sticture, diagnostic efficacy was best with the accuracy be-ing 84.0%(95%CI,64.7%-94.2%), sensitivity 87.5%(95% CI,62.7%-97.8%), specificity 77.8%(95%CI,44.3%-94.7%), positive positive predictive value 87.5% (95%CI,62.7%-97.8%), negative predictive value77.8%(95%CI,44.3%-94.7%)3. Accuracy, sensitivity, specificity, positive predictive value and negative predictive value were56.0%(95%CI,37.1%-73.4%),31.3%(95%CI,13.9%-55.9%),100% (95%CI,65.5%-100%),100%(95%CI,51.1%-100%),45.0%(95%CI, 25.8%-65.8%).Sensitivity and accuracy were significantly lower when compared to pCLE with above criteria(P=0.001 and P=0.03,respectivesly).4. According to the newly proposed classification in this study, When pCLE contains any two or more malignant signs, interobserver agreement level is substantial with k value being 0.73.ConclusionConfocal laser endomicroscopy showed high feasibility and security on bile duct strictures.Sensitivity, specificity and accuracy of CLE was superier than conventional brush cytology.Level of interobserver agreement is substantial. More clinical and la-boratory researches need to be implemented before the pCLE could be widely applied in clinical practice, as associations of pCLE signs with histology appearances have not been constructed in a concise way.SignificanceProbe-based confocal laser endomicroscopy is an real-time and effective technology with profound security. It avoids unnecesary delay for operation and waste of medical resource for repeat examination. Application of pCLE provides a new approach for biliary strictures. |
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