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Endoscopic Retrograde CholangioPancreatography Endomicroscopy Registry Outcomes Database


N/A
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer, Bile Duct Cancer

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Trial Information

Endoscopic Retrograde CholangioPancreatography Endomicroscopy Registry Outcomes Database


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.


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

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Comparative histopathology-confirmed measures of Cellvizio endomicroscopy and ERCP accuracy in the differential diagnosis of suspicious lesions.

Outcome Time Frame:

12-month diagnostic follow-up confirmation

Safety Issue:

Yes

Principal Investigator

Yang Chen, MD, FACP, FACG

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Colorado Hospital

Authority:

United States: Institutional Review Board

Study ID:

MKT-2008-ERCP-01

NCT ID:

NCT00779688

Start Date:

November 2008

Completion Date:

October 2010

Related Keywords:

  • Pancreatic Cancer
  • Bile Duct Cancer
  • 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)
  • Pancreatic Neoplasms
  • Bile Duct Neoplasms

Name

Location
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
University of Pittsburgh Medical Center Pittsburgh, Pennsylvania  15213
University of Colorado Hospital Denver, Colorado  80262
New York Presbyterian Hospital/Columbia University Medical Center New York, New York  10032