No registrations found.
ID
Source
Brief title
Health condition
primary sclerosing cholangitis
primary biliary cirrhosis
population-based epidemiology
case-control study
risk factors
natural history
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Relative risk determination of several putative environmental, behavioural and genetic risk factors between PSC and PBC as well as background population.
Background summary
Background 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.
15-jul-2017: 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.
Study objective
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.
Study design
N/A
Intervention
N/A
Academic Medical Center Amsterdam
PO Box 22660
C. IJ. Ponsioen
Amsterdam 1100 DD
The Netherlands
NA
c.y.ponsioen@amc.uva.nl
Academic Medical Center Amsterdam
PO Box 22660
C. IJ. Ponsioen
Amsterdam 1100 DD
The Netherlands
NA
c.y.ponsioen@amc.uva.nl
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
Inability to give informed consent.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2684 |
| NTR-old | NTR2813 |
| Other | METC UMC Utrecht : 06-267/E |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |