pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture
NCT ID: NCT01392274
Last Updated: 2014-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
121 participants
OBSERVATIONAL
2012-04-30
2013-09-30
Brief Summary
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Detailed Description
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The hypothesis is that ERCP with Cellvizio probe-based endomicroscopy improves differentiation of biliary and pancreatic duct lesions versus ERCP alone or ERCP with tissue sampling, by improving the sensitivity of detection and by providing a real-time diagnosis.
Direct measures of accuracy (sensitivity, specificity, etc.) in the differentiation of malignant versus benign biliary duct lesions will be compared for the combination of ERCP alone, endomicroscopy plus ERCP imaging, and ERCP plus endomicroscopy plus tissue sampling. These information will be reviewed retrospectively by a second physician.
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 patient management recommendation. Yet, effective management recommendation is left as the discretion of the physician.
Conditions
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Study Design
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PROSPECTIVE
Study Groups
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pCLE
This trial will study only one group which will receive a standard ERCP procedure followed by pCLE
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Indicated for ERCP for indeterminate bile duct stricture
* Referral patients with indeterminate biliary stricture coming in for first ERCP procedure at referral institution or
* Patients who had previous non-diagnostic tissue sampling (brushing biopsies or EUS-FNA) taken during a previous ERCP or EUS-FNA for an indeterminate biliary stricture
* Willing and able to comply with study procedures and provide written informed consent to participate in the study
Exclusion Criteria
* Known allergy to fluorescein dye
* Patients suffering Primary Sclerosing Cholangitis or chronic pancreatitis.
* Patients with post-transplant stricture
* If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding
18 Years
ALL
No
Sponsors
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Mauna Kea Technologies
INDUSTRY
Responsible Party
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Principal Investigators
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Adam Slivka, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburh Medical Center
Locations
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Yale new Haven Hospital
New Haven, Connecticut, United States
New York presbyterian Weill Cornell Medical center
New York, New York, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Institut Paoli Calmettes
Marseille, , France
Policlinico Univertitario Agostino Gemelli
Roma, , Italy
Countries
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References
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Slivka A, Gan I, Jamidar P, Costamagna G, Cesaro P, Giovannini M, Caillol F, Kahaleh M. Validation of the diagnostic accuracy of probe-based confocal laser endomicroscopy for the characterization of indeterminate biliary strictures: results of a prospective multicenter international study. Gastrointest Endosc. 2015 Feb;81(2):282-90. doi: 10.1016/j.gie.2014.10.009.
Other Identifiers
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MKT-2011-FOCUS
Identifier Type: -
Identifier Source: org_study_id