Pancreatic Cancer, Bile Duct Cancer
Conditions
Keywords
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)
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.
Interventions
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.
Sponsors
Cellvizio Inc.
Emissary International LLC
Mauna Kea Technologies
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Countries
France, Germany, United States
Outcome results
None listed