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

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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

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