Pancreatic Cancer Clinical Trial
Official title:
Endoscopic Retrograde CholangioPancreatography Endomicroscopy Registry Outcomes Database
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.
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Time Perspective: Prospective
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