Confocal Endomicroscopy for Biliary Strictures -Phase I

Stopped early · Not applicable

Conditions studied: Biliary Stricture

In brief

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 sensitivity compared to biliary brushing/biopsy, and that direct cholangioscopic guidance of pCLE is more accurate than fluoroscopic guidance.

Key facts

Study ID

NCT00892632

Run by

Mayo Clinic

People needed

12

Starts

2009-04-01

Expected to finish

2011-02-01

Last updated by the study team

2012-02-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Mayo Clinic — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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