A Registry of Patients Undergoing Cellvizio Endomicroscopy and Endoscopic Retrograde Cholangiopancreatography(ERCP) Imaging Procedures for Diagnosing Pancreatic and Bile Duct Cancers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Endoscopic Retrograde CholangioPancreatography Endomicroscopy Registry Outcomes Database

Conditions
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Pancreatic Cancer, Bile Duct Cancer

Intervention / Treatment
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* Device: Probe-based confocal laser endomicroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female > 18 years of age Willing and able to comply with Registry procedures and provide written informed consent to participate in the Registry Indicated for ERCP and/or cholangiopancreatoscopy Indeterminate or suspected biliary and/or pancreatic stricture, mass, or neoplasm Exclusion Criteria: Subjects for whom ERCP procedures are contraindicated Known allergy to fluorescein dye

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Probe-based confocal laser endomicroscopy|ERCP with or without cholangiopancreatoscopy will be performed by the endoscopist as clinically indicated. If findings at ERCP and/or prior imaging studies and/or clinical assessment suggest possible malignancy and/or an indeterminate biliary or pancreatic pathology Cellvizio probe-based endomicroscopy will be performed during ERCP.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparative histopathology-confirmed measures of Cellvizio endomicroscopy and ERCP accuracy in the differential diagnosis of suspicious lesions. |  | 12-month diagnostic follow-up confirmation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic Retrograde Cholangiopancreatography, ERCP, bile duct cancer, pancreatic duct cancer, gall bladder, pancreas, duodenoscope, Cellvizio, endomicroscopy, cholangiopancreatoscopy, Biliary Tract Neoplasms (suspected), Biliary Tract Mass (suspected), Biliary Tract Stricture (suspected), Pancreatic Duct Neoplasms (suspected), Pancreatic Duct Mass (suspected), Pancreatic Duct Stricture (suspected)