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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00779688
Recruitment Status : Completed
First Posted : October 24, 2008
Last Update Posted : February 10, 2011
Cellvizio Inc.
Emissary International LLC
Information provided by:
Mauna Kea Technologies

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.

Condition or disease Intervention/treatment
Pancreatic Cancer Bile Duct Cancer Device: Probe-based confocal laser endomicroscopy

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
Actual Enrollment : 130 participants
Time Perspective: Prospective
Official Title: Endoscopic Retrograde CholangioPancreatography Endomicroscopy Registry Outcomes Database
Study Start Date : November 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

Intervention Details:
  • 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.
    Other Names:
    • Cellvizio endomicroscopy
    • Confocal Laser Scanning Microscopy

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00779688

United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, New York
New York Presbyterian Hospital/Columbia University Medical Center
New York, New York, United States, 10032
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Institut Paoli-Calmettes
Marseilles, France, 13273
Klinikum rechts der Isar
Munich, Bayern, Germany, 81675
Sponsors and Collaborators
Mauna Kea Technologies
Cellvizio Inc.
Emissary International LLC
Principal Investigator: Yang Chen, MD, FACP, FACG University of Colorado, Denver

Responsible Party: Anne Osdoit / Clinical Affairs Manager, Mauna Kea Technologies Identifier: NCT00779688     History of Changes
Other Study ID Numbers: MKT-2008-ERCP-01
WIRB 20081709
First Posted: October 24, 2008    Key Record Dates
Last Update Posted: February 10, 2011
Last Verified: February 2011

Keywords provided by Mauna Kea Technologies:
Endoscopic Retrograde Cholangiopancreatography
bile duct cancer
pancreatic duct cancer
gall bladder
Biliary Tract Neoplasms (suspected)
Biliary Tract Mass (suspected)
Biliary Tract Stricture (suspected)
Pancreatic Duct Neoplasms (suspected)
Pancreatic Duct Mass (suspected)
Pancreatic Duct Stricture (suspected)

Additional relevant MeSH terms:
Pancreatic Neoplasms
Bile Duct Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Biliary Tract Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type