pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture
This trial aims at evaluating the performance diagnosis of pCLE for the detection of bile
duct cancer, in patients with indeterminate biliary stricture when associated with other
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
Time Perspective: Prospective
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
Adam Slivka, MD
University of Pittsburh Medical Center
United States: Institutional Review Board
|Virginia Mason Medical Center||Seattle, Washington 98111|
|University of Pittsburgh Medical Center||Pittsburgh, Pennsylvania 15213|
|Yale New Haven Hospital||New Haven, Connecticut 06520|
|New York Presbyterian Weill Cornell Medical Center||New York, New York 10021|