PROSPECTIVE STUDY OF THE PROGNOSTIC VALUE OF TRANSIENT ELASTOMETRY (FIBROSCAN) IN PRIMARY SCLEROSING CHOLANGITIS (PSC) PATIENTS (FICUS STUDY)

Completed

• Conditions: Primary sclerosing cholangitis. PSC. Bile duct disease.; 10004606; 10003816

• Registration Number: NL-OMON41962
• Lead Sponsor: MD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

1. PSC diagnosis as defined by the European Association for the Study of the Liver (EASL)
Practice Guidelines, including subgroups such as small duct PSC and auto-immune hepatitis *PSC overlap syndromes. There are no prohibited medications.
2. Age > 18 years and < 75 years
3. Written informed consent

Exclusion Criteria

1. Secondary sclerosing cholangitis (including IgG4-associated cholangitis)
2. Previous liver transplantation
3. Listed for liver transplantation
4. Presence of complication (ascites, encephalopathy, hepato-biliary malignancy)
5. Coexistent conditions that would limit life expectancy to less than 1 year
6. Associated liver disease of other etiology (chronic hepatitis B or C, chronic alcoholic liver disease, nonalcoholic steatohepatitis (NASH), hemochromatosis, Wilson*s disease or other significant liver disease)
7. Known pregnancy

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>Transplant free survival</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Prognostic value of Fibroscan on survival without liver transplantation (LT)<br /><br>and without liver complications (ascites, variceal bleeding, hepatic<br /><br>encephalopathy, hepatocellular carcinoma, cholangiocarcinoma, serum bilirubin<br /><br>level above 6 mg/dL for at least 3 months, listing for LT).<br /><br>* Time course of changes in liver stiffness<br /><br>* Correlation of liver stiffness with:<br /><br>o Histologic fibrosis (when liver biopsy available)<br /><br>o Biologic markers of fibrosis : nonproprietary scores (APRI, FIB-4), other<br /><br>markers*<br /><br>* Comparison of fibroscan to established, and to be discovered, alternate<br /><br>biomarkers of prognosis</p><br>