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.

Inclusion Criteria:

- Male or female > 18 years of age

- Indicated for ERCP for indeterminate bile duct stricture

- Referral patients with indeterminate biliary stricture coming in for first ERCP
procedure at referral institution or

- Patients who had previous non-diagnostic tissue sampling (brushing biopsies or
EUS-FNA) taken during a previous ERCP or EUS-FNA for an indeterminate biliary
stricture

- Willing and able to comply with study procedures and provide written informed consent
to participate in the study

Exclusion Criteria:

- Subjects for whom ERCP procedures are contraindicated

- Known allergy to fluorescein dye

- Patients suffering Primary Sclerosing Cholangitis or chronic pancreatitis.

- Patients with post-transplant stricture

- If female, pregnant based on a positive hCG serum or an in vitro diagnostic test
result or breast-feeding