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

October 22, 2008
February 9, 2011
November 2008
September 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00779688 on ClinicalTrials.gov Archive Site
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A Registry of Patients Undergoing Cellvizio Endomicroscopy and Endoscopic Retrograde Cholangiopancreatography(ERCP) Imaging Procedures for Diagnosing Pancreatic and Bile Duct Cancers
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.

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.

Observational
Time Perspective: Prospective
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Non-Probability Sample

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

  • Pancreatic Cancer
  • Bile Duct Cancer
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
October 2010
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Germany
 
NCT00779688
MKT-2008-ERCP-01, WIRB 20081709
No
Anne Osdoit / Clinical Affairs Manager, Mauna Kea Technologies
Mauna Kea Technologies
  • Cellvizio Inc.
  • Emissary International LLC
Principal Investigator: Yang Chen, MD, FACP, FACG University of Colorado Hospital
Mauna Kea Technologies
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP