No registrations found.
ID
Source
Brief title
Health condition
Primary Sclerosing Cholangitis
Sponsors and support
Intervention
Outcome measures
Primary outcome
prognostic value of MRCP+ with regard to transplant-free survival
Secondary outcome
individual features of MRCP+ with regard to their prognostic performance.
Background summary
Primary sclerosing cholangitis (PSC) is a chronic progressive biliary disease that affects approximately 1200 patients in the Netherlands and around 80,000 in the Western world. It is often accompanied by ulcerative colitis (UC) or Crohn’s disease affecting the large bowel. The cause of PSC is unknown, there is no medical therapy available that has proven to halt disease progression and the median time until death or liver transplantation is 21 years.Diagnosis is made by magnetic resonance cholangiography (MRC), or in the case of so called small duct disease by liver biopsy.
Due to the heterogeneous disease course and the relatively low clinical event rate of 5% per year it is difficult to predict prognosis of individual patients. Several prognostic models have been developed in the past, one of which making use of cholangiography, albeit by endoscopic retrograde cholangiography (ERC). This entails an invasive procedure, which is nowadays supplanted by MRC. Recently, a new post-processing tool has been developed to characterize and quantify abnormalities in the biliary tree as captured by MRC. This tool called MRCP+ holds the prospect of containing prognostic features as previously with the ERC derived cholangiographic scoring. We hypothesize that MRCP+ has predictive features in terms of time to transplantation or death.
Study objective
We hypothesize that MRCP+ has predictive features in terms of time to transplantation or death.
Study design
2021 November - Start study
2022 March - LPI
2022 April - Database completion
2022 April - Analysis of primary endpoint: C-statistic of the correlation between total bile duct volume and transplant-free survival
2022 May - Analysis of secondary endpoint: Hazard ratio of various semi-quantitative features of MRCP + and transplant-free survival.
2022 June - writing manuscript
Intervention
none
Inclusion criteria
established diagnosis according to the IPSCSG Definitions
Age ≥ 18
Informed consent for review of MRCP and clinical data
available MRCs from 2010 onwards
Exclusion criteria
Inability to give informed consent
insufficient image quality
LTx at the time of imaging.
Design
Recruitment
IPD sharing statement
Plan description
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 | NL9730 |
| Other | MEC AMC : 018 |