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
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.
Study Type
Observational
Primary Outcome
Comparative histopathology-confirmed measures of Cellvizio endomicroscopy and ERCP accuracy in the differential diagnosis of suspicious lesions.
Condition
Pancreatic Cancer
Intervention
Probe-based confocal laser endomicroscopy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
130
Start Date
November 2008
Completion Date
October 2010
Primary Completion Date
September 2009
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Yang Chen, MD, FACP, FACG, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT00779688
Organization ID
MKT-2008-ERCP-01
Secondary IDs
WIRB 20081709
Study Sponsor
Mauna Kea Technologies
Collaborators
Cellvizio Inc.
Study Sponsor
Yang Chen, MD, FACP, FACG, Principal Investigator, University of Colorado, Denver
Verification Date
February 2011