Epidemiology and Natural History of, and risk factors for Primary Sclerosing Cholangitis & Primary Biliary Cirrhosis in central Netherlands.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON27701

Enrollment

1800

Registered

2011-03-16

Start date

2007-06-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

primary sclerosing cholangitis primary biliary cirrhosis population-based epidemiology case-control study risk factors natural history

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age ≥ 18 years; 2. At least at one point during the period 1-1-2000 and 1-1-2007 resident in the abovementioned area; 3. Diagnosis of PSC according to established criteria and after revision of the principal investigator; 4. Diagnosis of PBC according to established criteria and after revision of the principal investigator, i.e. elevated serum alkaline phosphatase, positive anti-mitochondrial antibody titre and no signs of auto-immune hepatitis or drug-induced hepatitis; 5. Controls must have no history of liver disease and normal routine liver tests.

Exclusion criteria

Exclusion criteria: Inability to give informed consent.

Design outcomes

Primary

Measure	Time frame
1. True population-based point-prevalence (2006) and inferred incidence of newly diagnosed cases (2000-2006); 2. Natural history with respect to death, liver transplantation, occurrence of cholangiocarcinoma and colorectal carcinoma.	—

Secondary

Measure	Time frame
Relative risk determination of several putative environmental, behavioural and genetic risk factors between PSC and PBC as well as background population.	—

Contacts

Public ContactC. IJ. Ponsioen

Dept. Gastroenterology and Hepatology Academic Medical Center Amsterdam PO Box 22660

c.y.ponsioen@amc.uva.nl

Outcome results