Trial Information

pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture

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.