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


- candidate number9244
- NTR NumberNTR2813
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-mrt-2011
- Secondary IDs06-267/E METC UMC Utrecht
- Public TitleEpidemiology and Natural History of, and risk factors for Primary Sclerosing Cholangitis & Primary Biliary Cirrhosis in central Netherlands.
- Scientific TitleEpidemiology and Natural History of, and risk factors for Primary Sclerosing Cholangitis & Primary Biliary Cirrhosis in central Netherlands.
- ACRONYMEpi PSC PBC
- hypothesisPrimary sclerosing cholangitis (PSC) and primary biliary cirrhosis (PBC) are relatively rare liver diseases that in most cases lead to liver failure in 10-20 year. Nowadays, both diseases are regarded as immune dysbalance disease entities, but in fact the aetiology is unknown. Regarding the prevalence, incidence and natural history of PSC and PBC there are only crude estimates. True population-based studies have not been carried out.
- Healt Condition(s) or Problem(s) studiedRisk factors, Primary sclerosing cholangitis, Primary biliary cirrhosis, Population-based epidemiology, Natural history
- Inclusion criteria1. 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 criteriaInability to give informed consent.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jun-2007
- planned closingdate1-jun-2031
- Target number of participants1800
- InterventionsN/A
- Primary outcome1. 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 outcomeRelative risk determination of several putative environmental, behavioural and genetic risk factors between PSC and PBC as well as background population.
- TimepointsN/A
- Trial web sitewww.amc.nl/PSC
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. PhD. C. IJ. Ponsioen
- CONTACT for SCIENTIFIC QUERIESMD. PhD. C. IJ. Ponsioen
- Sponsor/Initiator Academic Medical Center (AMC), Department of Hepato- and Gastroenterology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Hepato- and Gastroenterology
- PublicationsN/A
- Brief summaryBackground of the study:
Primary sclerosing cholangitis (PSC) and primary biliary cirrhosis (PBC) are relatively rare liver diseases that in most cases lead to liver failure in 10-20 year. Nowadays, both diseases are regarded as immune dysbalance disease entities, but in fact the aetiology is unknown. Regarding the prevalence, incidence and natural history of PSC and PBC there are only crude estimates. True population-based studies have not been carried out.

Objective of the study:
Main objectives: To obtain true population-based prevalence and incidence figures, as well as insight in the natural history of PSC and PBC in The Netherlands. Secondary objectives: to determine risk factors correlated with PSC and PBC respectively, such as environmental factors, behavioural factors and genetic factors; to build two large inception cohorts of PSC and PBC patients for future studies.

Study design:
Observational longitudinal cohort study with case-control substudies. In all hospitals of the Gut-club-, Stichts Genootschap-, and Duamutef Society members all PSC and PBC patients from 2000-2006 will be traced via several independent local search strategies. Charts will be reviewed for relevant data. Follow-up data will be collected by yearly correspondence.

Study population:
All 45 general and academic hospitals of the provinces of North-Holland, Flevoland, Overijssel, Utrecht, Gelderland and Drenthe covering a population of more than 8,000,000 inhabitants, will participate. All cases ≥ 18 years of age meeting accepted criteria for a diagnosis of PSC or PBC will be included. Two controlgroups will be accrued; one IBD-patients group and one general GI-outpatient group.
- Main changes (audit trail)15-jul-2017 MT: Most important changes
As the epidemiological research questions have been answered yet (Boonstra et al., 2013), but many questions about the natural course and risk factors remain, this study will continue in a adapted format. The study area is extended, all Dutch PSC patients can be included. Patients will receive periodical digital questionnaires. For follow-up we will ask local doctors to send us a letter yearly.
- RECORD16-mrt-2011 - 15-jul-2017


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