pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture (FOCUS)
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).
Bile Duct Inflammation
|Study Design:||Time Perspective: Prospective|
|Official Title:||pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture|
- Comparative histopathology-confirmed measures of Cellvizio endomicroscopy and ERCP accuracy in the differential diagnosis of suspicious l [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]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
- Comparative histopathology-confirmed measures of Cellvizio endomicroscopy and ERCP accuracy in the differential diagnosis of suspicious l [ Time Frame: 12 months follow-up ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2012|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
This trial will study only one group which will receive a standard ERCP procedure followed by pCLE
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 diagnostic information.
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 physician.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01392274
|United States, Connecticut|
|Yale new Haven Hospital|
|New Haven, Connecticut, United States, 06510|
|United States, New York|
|New York presbyterian Weill Cornell Medical center|
|New york, New York, United States, 10065|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Washington|
|Virginia Mason Medical Center|
|Seattle, Washington, United States, 98111|
|Institut Paoli Calmettes|
|Marseille, France, 13000|
|Policlinico Univertitario Agostino Gemelli|
|Roma, Italy, 00168|
|Principal Investigator:||Adam Slivka, MD||University of Pittsburh Medical Center|