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

February 9, 2011 updated by: Mauna Kea Technologies

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseilles, France, 13273
        • Institut Paoli-Calmettes
  • Germany
    • Bayern
      • Munich, Bayern, Germany, 81675
        • Klinikum rechts der Isar
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • New York
      • New York, New York, United States, 10032
        • New York Presbyterian Hospital/Columbia University Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mauna Kea Technologies

Collaborators

Emissary International LLC
Cellvizio Inc.

Investigators

  • Principal Investigator: Yang Chen, MD, FACP, FACG, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

October 22, 2008

First Submitted That Met QC Criteria

October 23, 2008

First Posted (Estimate)

October 24, 2008

Study Record Updates

Last Update Posted (Estimate)

February 10, 2011

Last Update Submitted That Met QC Criteria

February 9, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MKT-2008-ERCP-01
  • WIRB 20081709

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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