Value of MRCP+ And Liver Multiscan in the management of Dominant strictures in primary sclerosing cholangitis

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, two new post-processing tools have been developed to characterize and
quantify abnormalities in the biliary tree as well as excretory function
captured by MRC. These tools called MRCP+ and Liver Multiscan (LMS) hold the
prospect of adequate depicting and quantifying lesions of the biliary tree as
well as capturing functional derailment.
However, before this can be concluded several features must be tested. The most
important ones being (i) sensitivity to change, (ii) reproducibility, and (iii)
correlation with ERC findings as gold standard. The aim of the current study is
to test these features in patients that are scheduled for a therapeutic ERC.

Primary Objective:
Assess the ability of MRCP+ and LMS to detect change in total biliary volume
and cT1 value, 8 weeks after endoscopic treatment of dominant strictures, by a
clinical decision rule.

Secondary Objective(s):
Assess natural course of MRCP+ and LMS metrics in subjects that are not
eligible for ERC.
Assess the ability of MRCP+ and LMS to detect change in total biliary volume
and cT1 value, 8 weeks after the second treatment of a DS that was
unsuccessfully treated at the first ERC.
Comparison of baseline MRCP+ metrics with gold-standard ERC
Correct identification of dominant strictures (DS) eligible for treatment
Reproducibility of strictures not treated at index ERC

Prospective, singlecenter study.

There is little burden or risk associated with this study as it requires an
additional sequences of LMS will be performed before ERC and one extra MRI
liver, MRC and LMS sequences that would otherwise not be planned routinely on
t=8w. The analysis of MRCP+ and LMS will be done after the imaging is
performed. Furthermore, there is no risk attached to performing the MRCP+ and
LMS as results of both software programs don*t alter therapy or diagnosis for
patients.