Status:
TERMINATED
Confocal Endomicroscopy for Biliary Strictures -Phase I
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Leadiant Biosciences, Inc.
Conditions:
Biliary Stricture
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The investigators hypothesize that the confocal endomicroscopy imaging of the biliary strictures during ERCP will differentiate between benign and malignant strictures in vivo and has increased sensit...
Detailed Description
Despite recent advances in biliary imaging and biliary tissue acquisition, the diagnosis and tissue-confirmation in suspected malignant biliary obstruction remains challenging. Patients often undergo ...
Eligibility Criteria
Inclusion
- Pre-ERCP: Age above 18; imaging consistent with stenosis/mass of the hilum/extra-hepatic bile duct with abnormal liver chemistry, or painless jaundice referred for ERCP.
- Evidence of biliary obstruction as defined by elevated direct bilirubin (\> 1.5ULN) and dilation of the common or hepatic ducts \> 8mm) on imaging studies.
Exclusion
- Unwilling/unable to consent.
- Definite pancreatic mass on CT/MR.
- Allergy to Fluorescein.
- Pregnancy (patient who could be pregnant will undergo pregnancy testing as per routine care)
- Indwelling metal biliary stent.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00892632
Start Date
April 1 2009
End Date
February 1 2011
Last Update
February 24 2012
Active Locations (1)
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1
Mayo Clinic
Jacksonville, Florida, United States, 32224