pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture (FOCUS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01392274|
Recruitment Status : Completed
First Posted : July 12, 2011
Last Update Posted : December 4, 2014
|Condition or disease|
|Cholangiocarcinoma Bile Duct Inflammation|
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.
|Study Type :||Observational|
|Actual Enrollment :||121 participants|
|Official Title:||pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
This trial will study only one group which will receive a standard ERCP procedure followed by pCLE
- Comparative histopathology-confirmed measures of Cellvizio endomicroscopy and ERCP accuracy in the differential diagnosis of suspicious l [ Time Frame: 12 months ]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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|