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

This study has been completed.
Sponsor:
Collaborators:
Cellvizio Inc.
Emissary International LLC
Information provided by:
Mauna Kea Technologies
ClinicalTrials.gov Identifier:
NCT00779688
First received: October 22, 2008
Last updated: February 9, 2011
Last verified: February 2011
  Purpose

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 Intervention
Pancreatic Cancer
Bile Duct Cancer
Device: Probe-based confocal laser endomicroscopy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Endoscopic Retrograde CholangioPancreatography Endomicroscopy Registry Outcomes Database

Resource links provided by NLM:


Further study details as provided by Mauna Kea Technologies:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 130
Study Start Date: November 2008
Study Completion Date: October 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00779688

Locations
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
France
Institut Paoli-Calmettes
Marseilles, France, 13273
Germany
Klinikum rechts der Isar
Munich, Bayern, Germany, 81675
Sponsors and Collaborators
Mauna Kea Technologies
Cellvizio Inc.
Emissary International LLC
Investigators
Principal Investigator: Yang Chen, MD, FACP, FACG University of Colorado, Denver
  More Information

No publications provided

Responsible Party: Anne Osdoit / Clinical Affairs Manager, Mauna Kea Technologies
ClinicalTrials.gov Identifier: NCT00779688     History of Changes
Other Study ID Numbers: MKT-2008-ERCP-01, WIRB 20081709
Study First Received: October 22, 2008
Last Updated: February 9, 2011
Health Authority: United States: Institutional Review Board
Germany: German Institute of Medical Documentation and Information
France: National Consultative Ethics Committee for Health and Life Sciences

Keywords provided by Mauna Kea Technologies:
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)

Additional relevant MeSH terms:
Pancreatic Neoplasms
Bile Duct Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Biliary Tract Neoplasms
Bile Duct Diseases
Biliary Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014