Cholangiocarcinoma Clinical Trial
— FOCUSOfficial title:
pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture
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).
Status | Completed |
Enrollment | 121 |
Est. completion date | September 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
France | Institut Paoli Calmettes | Marseille | |
Italy | Policlinico Univertitario Agostino Gemelli | Roma | |
United States | 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 |
Lead Sponsor | Collaborator |
---|---|
Mauna Kea Technologies |
United States, France, Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparative histopathology-confirmed measures of Cellvizio endomicroscopy and ERCP accuracy in the differential diagnosis of suspicious l | Evaluation of pCLE diagnostic performance for the diagnosis of indeterminate biliary stricture (ie. number of patients accurately diagnosed) when associated with other diagnostic information The following calculations will be conducted: sensitivity, specificity, positive and negative predictive values, Accuracy | 12 months | Yes |
Secondary | Comparative histopathology-confirmed measures of Cellvizio endomicroscopy and ERCP accuracy in the differential diagnosis of suspicious l | 12 months follow-up | Yes |
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