Clinical trial NCT05359497: Value of MRCP+ And Liver Multiscan in the Management of Dominant Strictures in Primary Sclerosing Cholangitis
Official title: Value of MRCP+ And Liver Multiscan in the Management of Dominant Strictures in Primary Sclerosing Cholangitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PSC
MRI
Keywords: Liver Multiscan
MRCP+
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Perspectum
First posted: 2022-05-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, observational study
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in total biliary volume by MRCP+ and cT1 by LMS 8 weeks after endoscopic treatment of dominant strictures
timeFrame: 1st MRI: Baseline = week 0. 2nd MRI: week 8 after ERCP
Secondary outcomes:
measure: Correlation of MRCP+/Liver Multiscan with the modified Amsterdam cholangiographic classification
timeFrame: 1st MRI: Baseline = week 0. 2nd MRI: week 8 after ERCP
measure: Correlation of imaging features of MRCP+ with classic cholangiography in individual areas of interest by two independent assessors.
timeFrame: 1st MRI: Baseline = week 0. 2nd MRI: week 8 after ERCP
measure: Correlation of dominant strictures rated by MRCP+/Liver Multiscan with those assessed by classic definition of dominant strictures.
timeFrame: 1st MRI: Baseline = week 0. 2nd MRI: week 8 after ERCP
measure: Repeated detection of dominant strictures, as determined by two independent assessors, that were not treated by ERC
timeFrame: 1st MRI: Baseline = week 0. 2nd MRI: week 8 after ERCP
Other outcomes:
Locations:
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Cyriel Ponsioen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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