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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON41962

Enrollment

Registered

2015-03-19

Start date

2015-06-15

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary sclerosing cholangitis. PSC. Bile duct disease.

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Transplant free survival	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results