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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 : November 21, 2018
Sponsor:
Collaborators:
University of Pittsburgh
Weill Medical College of Cornell University
Northwell Health
Methodist Health System
Ochsner Health System
Mauna Kea Technologies
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:

Primary sclerosing cholangitis (PSC)

  1. Prospectively validate interpretation criteria for the characterization of PSC strictures
  2. 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
  3. 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

  Show Detailed Description

Study Type : Observational [Patient Registry]
Actual Enrollment : 65 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : February 2019


Group/Cohort Intervention/treatment
PSC
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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Feasibility of Technical Performance based on image quality [ Time Frame: 2 years ]
    Technical performance based on image quality.

  2. Feasibility of Technical Performance based on tissue sampling accuracy [ Time Frame: 2 years ]
    Tissue sampling accuracy based on tissue sampling accuracy.



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with primary sclerosing cholangitis and a dominant stricture within the liver.
Criteria

Inclusion Criteria:

  • Male or female > 18 years of age
  • Clinically Indicated for ERCP and/or cholangioscopy for PSC stricture
  • Inclusion of patients either previously stented or not

Exclusion Criteria:

  • Subjects for whom ERCP procedures are contraindicated
  • Known allergy to fluorescein dye
  • Presence of well-defined intrahepatic mass
  • Ascending cholangitis, febrile at time of procedure
  • Pregnancy

Information from the National Library of Medicine

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


Locations
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
University of Pittsburgh
Weill Medical College of Cornell University
Northwell Health
Methodist Health System
Ochsner Health System
Mauna Kea Technologies
Investigators
Principal Investigator: Raj Shah, MD University of Colorado, Denver

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02736708     History of Changes
Other Study ID Numbers: 12-1516
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Colorado, Denver:
Primary sclerosing cholangitis

Additional relevant MeSH terms:
Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases