Fluorescence in situ hybridization in the early diagnosis of cholangiocarcinoma in patients with primary sclerosing cholangitis

Completed

• Conditions: Primary Sclerosing Cholangitis; Progressive inflammation of the bilde ducts more likely to develop into cancer; 10019815

• Registration Number: NL-OMON37613
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 125

Inclusion Criteria

Patients from the AMC PSC surveillance cohort with PSC who will undergo ERCP indicated per standard practice.

Exclusion Criteria

Inability to pass a guidewire through the stricture

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* Sensitivity, specificity, positive prognostic value (PPV) and negative<br /><br>prognostic value (NPV) of different FISH markers for the detection of<br /><br>(PSC-related) CCA.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Sensitivity, specificity, PPV and NPV of conventional cytology.<br /><br>* Sensitivity, specificity, PPV and NPV of different FISH markers while<br /><br>preserving the specificity of cytology.<br /><br>* Sensitivity, specificity, PPV and NPV of FISH when FISH is positive and<br /><br>conventional cytology is neither positive nor suspicious for cancer. </p><br>