Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy for PSC Biliary Strictures

NCT02736708 | Completed

• 1 other identifier: 12-1516
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

Primary sclerosing cholangitis (PSC)

1. 1.Prospectively validate interpretation criteria for the characterization of PSC strictures
2. 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. 3.Evaluate the feasibility and safety of pCLE for the characterization of PSC strictures

Conditions

Primary Sclerosing Cholangitis

Keywords

Primary sclerosing cholangitis

Outcome Measures

Primary Outcomes (2)

• Sensitivity of ERCP with probe-based endomicroscopy

  Sensitivity of ERCP with probe-based endomicroscopy for the differentiation between PSC and PSC-malignant stenosis.

  2 years

• Differentiation between PSC and PSC-malignant stenosis

  Sensitivity of ERCP with probe-based endomicroscopy for the differentiation between PSC and PSC-malignant stenosis.

  2 years

Secondary Outcomes (2)

• Feasibility of Technical Performance based on image quality

  2 years

• Feasibility of Technical Performance based on tissue sampling accuracy

  2 years

Study Arms (1)

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

Interventions

probe based confocal laser endomicroscopy DEVICE

real-time, microscopic imaging of tissue at the cellular level via a small diameter probe.

Also known as: pCLE, Cellvizio

PSC

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with primary sclerosing cholangitis and a dominant stricture within the liver.

You may qualify if:

• Male or female \> 18 years of age
• Clinically Indicated for ERCP and/or cholangioscopy for PSC stricture

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• University of Pittsburgh: collaborator
• Weill Medical College of Cornell University: collaborator
• Northwell Health: collaborator
• Methodist Health System: collaborator
• Ochsner Health System: collaborator
• Mauna Kea Technologies: collaborator

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• Han S, Kahaleh M, Sharaiha RZ, Tarnasky PR, Kedia P, Slivka A, Chennat JS, Joshi V, Sejpal DV, Sethi A, Shah RJ. Probe-based confocal laser endomicroscopy in the evaluation of dominant strictures in patients with primary sclerosing cholangitis: results of a U.S. multicenter prospective trial. Gastrointest Endosc. 2021 Sep;94(3):569-576.e1. doi: 10.1016/j.gie.2021.03.027. Epub 2021 Mar 30.

  PMID: 33798541 DERIVED

MeSH Terms

Conditions

Cholangitis, Sclerosing

Condition Hierarchy (Ancestors)

Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Raj Shah, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2015
• First Posted: April 13, 2016
• Study Start: January 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: May 1, 2020
• Last Updated: August 26, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)