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

Not Applicable

• Conditions: MRI; PSC
• Interventions: 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

• Registration Number: NCT05359497
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-03-23
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-29
• Last Update Submitted: 2022-04-29
• Study Start: 2022-05-01
• Study First Posted: 2022-05-04
• Last Update Posted: 2022-05-04
• Primary Completion: 2023-05
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Additional sequences and extra MRI	Liver Multiscan sequences baseline	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.
Additional sequences and extra MRI	MRI liver with MRCP	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.
Additional sequences and extra MRI	MRCP+ analysis baseline	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.
Additional sequences and extra MRI	Liver Multiscan analysis baseline	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.
Additional sequences and extra MRI	Liver Multiscan analysis follow up	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.
Additional sequences and extra MRI	Liver Multiscan sequences follow-up	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.
Additional sequences and extra MRI	MRCP+ analysis follow up	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.

Primary Outcome Measures

Name	Time	Method
Change in total biliary volume by MRCP+ and cT1 by LMS 8 weeks after endoscopic treatment of dominant strictures	1st MRI: Baseline = week 0. 2nd MRI: week 8 after ERCP	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.

Secondary Outcome Measures

Name	Time	Method
Correlation of MRCP+/Liver Multiscan with the modified Amsterdam cholangiographic classification	1st MRI: Baseline = week 0. 2nd MRI: week 8 after ERCP	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.
Correlation of imaging features of MRCP+ with classic cholangiography in individual areas of interest by two independent assessors.	1st MRI: Baseline = week 0. 2nd MRI: week 8 after ERCP	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.
Repeated detection of dominant strictures, as determined by two independent assessors, that were not treated by ERC	1st MRI: Baseline = week 0. 2nd MRI: week 8 after ERCP	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.
Correlation of dominant strictures rated by MRCP+/Liver Multiscan with those assessed by classic definition of dominant strictures.	1st MRI: Baseline = week 0. 2nd MRI: week 8 after ERCP	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.