A Registry of Patients Undergoing Cellvizio Endomicroscopy and Endoscopic Retrograde Cholangiopancreatography(ERCP) Imaging Procedures for Diagnosing Pancreatic and Bile Duct Cancers
A Registry of Patients Undergoing Cellvizio Endomicroscopy and Endoscopic Retrograde Cholangiopancreatography(ERCP) Imaging Procedures for Diagnosing Pancreatic and Bile Duct Cancers
This registry will collect data from patients routinely undergoing an ERCP and Cellvizio
 endomicroscopy procedure (and optionally an additional cholangiopancreatoscopy procedure) due
 to suspected pancreatic or bile duct cancer. The objective is to determine if endomicroscopy
 images collected using the marketed Cellvizio device may help endoscopists more accurately
 diagnose, in conjunction with traditional tissue sampling techniques, whether a suspected
 lesion is malignant or benign.
This is a registry study to collect high quality longitudinal data from patients with
 suspected or indeterminate pancreaticobiliary pathology who are undergoing an ERCP with
 Cellvizio probe-based endomicroscopy procedure, with or without supplemental direct
 cholangiopancreatoscopy. The hypothesis is that ERCP with Cellvizio probe-based
 endomicroscopy improves differentiation of biliary and pancreatic duct lesions versus ERCP
 alone.

 Direct measures of accuracy (sensitivity, specificity, etc.) in the differentiation of
 malignant versus benign biliary and/or pancreatic duct lesions will be compared for the
 combination of endomicroscopy and ERCP imaging and ERCP alone. 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 various safety and technical performance parameters.
Inclusion Criteria:

 1. Male or female > 18 years of age

 2. Willing and able to comply with Registry procedures and provide written informed
 consent to participate in the Registry

 3. Indicated for ERCP and/or cholangiopancreatoscopy

 4. Indeterminate or suspected biliary and/or pancreatic stricture, mass, or neoplasm

 Exclusion Criteria:

 1. Subjects for whom ERCP procedures are contraindicated

 2. Known allergy to fluorescein dye