pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture (FOCUS)

• Comparative histopathology-confirmed measures of Cellvizio endomicroscopy and ERCP accuracy in the differential diagnosis of suspicious l [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  Evaluation of pCLE diagnostic performance for the diagnosis of indeterminate biliary stricture (ie. number of patients accurately diagnosed) when associated with other diagnostic information The following calculations will be conducted: sensitivity, specificity, positive and negative predictive values, Accuracy
  
  

• Comparative histopathology-confirmed measures of Cellvizio endomicroscopy and ERCP accuracy in the differential diagnosis of suspicious l [ Time Frame: 12 months follow-up ] [ Designated as safety issue: Yes ]
  

This trial aims at evaluating the performance diagnosis of pCLE for the detection of bile duct cancer, in patients with indeterminate biliary stricture when associated with other diagnostic information.

The hypothesis is that ERCP with Cellvizio probe-based endomicroscopy improves differentiation of biliary and pancreatic duct lesions versus ERCP alone or ERCP with tissue sampling, by improving the sensitivity of detection and by providing a real-time diagnosis.

Direct measures of accuracy (sensitivity, specificity, etc.) in the differentiation of malignant versus benign biliary duct lesions will be compared for the combination of ERCP alone, endomicroscopy plus ERCP imaging, and ERCP plus endomicroscopy plus tissue sampling. These information will be reviewed retrospectively by a second physician.

These presumptive diagnoses will be compared against a 12-month follow-up confirmed histopathologic endpoint (an initially-benign pathologic diagnosis will be confirmed by a 12-month follow-up). Secondary objectives include collecting patient management recommendation. Yet, effective management recommendation is left as the discretion of the physician.