pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture

Completed

Conditions studied: Cholangiocarcinoma, Bile Duct Inflammation

In brief

This study will collect data from patients undergoing an ERCP procedure with probe-based Confocal Laser Endomicroscopy for suspicion of bile duct cancer. the objective is to evaluate the diagnostic performance of pCLE for the diagnosis of indeterminate biliary stricture when associated with other diagnostic information (standard ERCP and tissue sampling).

Key facts

Study ID

NCT01392274

Run by

Mauna Kea Technologies

People needed

121

Starts

2012-04-01

Expected to finish

2013-09-01

Last updated by the study team

2014-12-04

Who can join

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

You may qualify if…

• Male or female > 18 years of age
• 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

You may not qualify if…

• Subjects for whom ERCP procedures are contraindicated
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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