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Brief Title: A Registry of Patients Undergoing Cellvizio Endomicroscopy and Endoscopic Retrograde Cholangiopancreatography(ERCP) Imaging Procedures for Diagnosing Pancreatic and Bile Duct Cancers
Official Title: Endoscopic Retrograde CholangioPancreatography Endomicroscopy Registry Outcomes Database
Study ID: NCT00779688
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Colorado Hospital, Aurora, Colorado, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
New York Presbyterian Hospital/Columbia University Medical Center, New York, New York, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Institut Paoli-Calmettes, Marseilles, , France
Klinikum rechts der Isar, Munich, Bayern, Germany
Name: Yang Chen, MD, FACP, FACG
Affiliation: University of Colorado, Denver
Role: PRINCIPAL_INVESTIGATOR