There were no pCLE-related adverse events in the study and 89 patients were finally evaluable, of whom 40 were proven to have cancer. The sensitivity, specificity, positive-predictive value, and negative- predictive value of pCLE for detecting cancerous strictures were 98%, 67%, 71%, and 97%, respectively,compared with 45%, 100%, 100%, and 69% for index pathology. This resulted in an overall accuracy of 81% for pCLE compared with 75% for index pathology. Accuracy for combination of ERCP and pCLE was significantly higher compared with ERCP with tissue acquisition (90% vs. 73%; P .001).