Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy for PSC Biliary Strictures (PSCRegistry)
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|ClinicalTrials.gov Identifier: NCT02736708|
Recruitment Status : Active, not recruiting
First Posted : April 13, 2016
Last Update Posted : April 6, 2020
Primary sclerosing cholangitis (PSC)
- Prospectively validate interpretation criteria for the characterization of PSC strictures
- Prospectively evaluate the accuracy of pCLE for the characterization of PSC strictures (differentiation between malignant vs. non malignant strictures), using the newly developed interpretation criteria
- Evaluate the feasibility and safety of pCLE for the characterization of PSC strictures
|Condition or disease||Intervention/treatment|
|Primary Sclerosing Cholangitis||Device: probe based confocal laser endomicroscopy|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||65 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy for Primary Sclerosing Cholangitis Biliary Strictures|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||May 2020|
Male or female > 18 years of age Clinically Indicated for ERCP and/or cholangioscopy for dominant PSC stricture Inclusion of patients either previously stented or not
Device: probe based confocal laser endomicroscopy
real-time, microscopic imaging of tissue at the cellular level via a small diameter probe.
Other Name: pCLE, Cellvizio
- Sensitivity of ERCP with probe-based endomicroscopy [ Time Frame: 2 years ]Sensitivity of ERCP with probe-based endomicroscopy for the differentiation between PSC and PSC-malignant stenosis.
- Differentiation between PSC and PSC-malignant stenosis [ Time Frame: 2 years ]Sensitivity of ERCP with probe-based endomicroscopy for the differentiation between PSC and PSC-malignant stenosis.
- Feasibility of Technical Performance based on image quality [ Time Frame: 2 years ]Technical performance based on image quality.
- Feasibility of Technical Performance based on tissue sampling accuracy [ Time Frame: 2 years ]Tissue sampling accuracy based on tissue sampling accuracy.
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): NCT02736708
|United States, Colorado|
|University of Colorado|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Raj Shah, MD||University of Colorado, Denver|