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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 CenterBoston, Massachusetts  02215
University of Pittsburgh Medical CenterPittsburgh, Pennsylvania  15213
University of Colorado HospitalDenver, Colorado  80262
New York Presbyterian Hospital/Columbia University Medical CenterNew York, New York  10032