Value of MRCP+ And Liver Multiscan in the Management of Dominant Strictures in Primary Sclerosing Cholangitis

Study Overview
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Brief Summary
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Primary sclerosing cholangitis (PSC) is a chronic progressive biliary disease. 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. Novel imaging techniques 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, these features must be tested first. The purpose of this study is to assess the (i) ability of MRCP+ to detect change in biliary volume, (ii) reproducibility of MRCP+ and LMS, and (iii) correlation of MRCP+ with ERC findings as gold standard.

Detailed Description
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After informed consent, patients will undergo standard care with blood tests and MRI/MRCP. While performing the MRI, additional sequences called LMS are performed. Thereafter, an ERCP will be performed. Approximately 8 weeks after ERCP, another MRI/MRCP and LMS will be performed. Also, blood tests will be performed and a clinician will evaluate the clinical condition and complaints of patients Images will be coded and analysed by Perspectum to retrieve MRCP+ and LMS results.

Official Title
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Value of MRCP+ And Liver Multiscan in the Management of Dominant Strictures in Primary Sclerosing Cholangitis

Conditions
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PSC, MRI

Intervention / Treatment
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* Diagnostic Test: Liver Multiscan sequences baseline
* Device: MRCP+ analysis baseline
* Device: Liver Multiscan analysis baseline
* Diagnostic Test: MRI liver with MRCP
* Diagnostic Test: Liver Multiscan sequences follow-up
* Device: MRCP+ analysis follow up
* Device: Liver Multiscan analysis follow up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Established diagnosis according to the IPSCSG Definitions (22) Age ≥ 18 Able to give informed consent Clinically suspicious for a dominant stricture Exclusion Criteria: insufficient image quality known allergy for MRI contrast agents

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, observational study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Additional sequences and extra MRI<br>PSC patients, suspected for having a dominant stenosis, that undergo additional LMS sequences next to standard care MRI prior to ERCP and an additional MRI/MRCP with additional LMS sequences 8 weeks after ERCP. MRI images will be analysed by the post-processing tool called MRCP+ and Liver Multiscan, which are performed after the MRI is performed. | Diagnostic Test: Liver Multiscan sequences baseline<br>* Additional Liver Multiscan sequences at baseline besides standard care MRI liver /MRCP prior to ERCP.<br>Device: MRCP+ analysis baseline<br>* Post processing tool (Software) for quantifying MRCP images after MRCP is performed. Patient involvement is not necessary during this procedure.<br>Device: Liver Multiscan analysis baseline<br>* Post processing tool (Software) for determining the corrected T1 time after the additional LMS sequences at baseline are performed. This cT1 reflects the activity of inflammation/fibrosis of the liver. Patient involvement is not necessary during this procedure.<br>* Other names: LMS;Diagnostic Test: MRI liver with MRCP<br>* An extra MRI liver with contrast and MRCP is performed 8 weeks after the ERCP following standard care protocol<br>Diagnostic Test: Liver Multiscan sequences follow-up<br>* Additional Liver Multiscan sequences are performed at 8 weeks after ERCP.<br>Device: MRCP+ analysis follow up<br>* Post processing tool (Software) for quantifying MRCP images after the MRCP from follow up is performed. Patient involvement is not necessary during this procedure.<br>Device: Liver Multiscan analysis follow up<br>* Post processing tool (Software) for determining the corrected T1 time after the additional LMS sequences from the follow up scan are performed. This cT1 reflects the activity of inflammation/fibrosis of the liver. Patient involvement is not necessary during this procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total biliary volume by MRCP+ and cT1 by LMS 8 weeks after endoscopic treatment of dominant strictures | Decrease in total biliary volume (in ml, measured by MRCP+) and decrease in cT1 (in ms, measured by LiverMultiscan), which will be assessed by performing paired t-tests. | 1st MRI: Baseline = week 0. 2nd MRI: week 8 after ERCP | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of MRCP+/Liver Multiscan with the modified Amsterdam cholangiographic classification | The outcomes of both MRCP+ and Liver Multiscan of the baseline MRI will be compared with the modified amsterdam cholangiographic classification and the correlation coefficient will be calculated. The cholangiographic classification uses age and classification of the intrahepatic and extrahepatic biliary ducts to determine a prognostic score. This score ranges from 0-40, in which a score of 40 reflects the worst prognosis with e.g. a 1-year survival of 29% and 5-year survival of 3.3%, while zero points reflect a 1-year or 5-year survival of 98% or 94%, respectively. | 1st MRI: Baseline = week 0. 2nd MRI: week 8 after ERCP | 
| Correlation of imaging features of MRCP+ with classic cholangiography in individual areas of interest by two independent assessors. | MRCP+ given dilatations and strictures are compared with the in-depth assessment of strictures and dilatations of the MRCP, by two independent radiologists, specialized in MRCP. The correlation coefficient will be calculated. | 1st MRI: Baseline = week 0. 2nd MRI: week 8 after ERCP | 
| Correlation of dominant strictures rated by MRCP+/Liver Multiscan with those assessed by classic definition of dominant strictures. | MRCP+ given strictures with increased liver multiscan values are compared with the assessment (by the hand of the classic definition) of strictures found on MRCP images. The assessment is performed by two independent radiologists, specialized in MRCP. The correlation coefficient will be calculated. | 1st MRI: Baseline = week 0. 2nd MRI: week 8 after ERCP | 
| Repeated detection of dominant strictures, as determined by two independent assessors, that were not treated by ERC | MRI baseline and follow-up will be assessed for dominant strictures to determine the reproducibility (capability to detect dominant strictures on both baseline and follow-up MRI) of dominant strictures that were not actively treated (dilated) with the invasive ERC. The assessment is performed by two independent radiologists, specialized in MRCP. | 1st MRI: Baseline = week 0. 2nd MRI: week 8 after ERCP | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver Multiscan, MRCP+