Clinical trial NCT00779688: A Registry of Patients Undergoing Cellvizio Endomicroscopy and Endoscopic Retrograde Cholangiopancreatography(ERCP) Imaging Procedures for Diagnosing Pancreatic and Bile Duct Cancers
Official title: Endoscopic Retrograde CholangioPancreatography Endomicroscopy Registry Outcomes Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Bile Duct Cancer
Keywords: 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)
Lead sponsor: Mauna Kea Technologies
Sponsor class: INDUSTRY
Collaborators: name: Cellvizio Inc.
name: Emissary International LLC
First posted: 2008-10-24
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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

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.

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 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

Primary outcomes:
measure: Comparative histopathology-confirmed measures of Cellvizio endomicroscopy and ERCP accuracy in the differential diagnosis of suspicious lesions.
timeFrame: 12-month diagnostic follow-up confirmation
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: New York
country: United States
facility: New York Presbyterian Hospital/Columbia University Medical Center
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Marseilles
country: France
facility: Institut Paoli-Calmettes
city: Munich
country: Germany
facility: Klinikum rechts der Isar
state: Bayern
Study officials:
affiliation: University of Colorado, Denver
name: Yang Chen, MD, FACP, FACG
role: PRINCIPAL_INVESTIGATOR
References: