Value of MRCP+ And Liver Multiscan in the Management of Dominant Strictures in Primary Sclerosing Cholangitis
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- Change in total biliary volume by MRCP+ and cT1 by LMS 8 weeks after endoscopic treatment of dominant strictures
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established diagnosis according to the IPSCSG Definitions (22)
- •Able to give informed consent
- •Clinically suspicious for a dominant stricture
排除标准
- •insufficient image quality
- •known allergy for MRI contrast agents
结局指标
主要结局
Change in total biliary volume by MRCP+ and cT1 by LMS 8 weeks after endoscopic treatment of dominant strictures
时间窗: 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.
次要结局
- Correlation of MRCP+/Liver Multiscan with the modified Amsterdam cholangiographic classification(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.(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(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.(1st MRI: Baseline = week 0. 2nd MRI: week 8 after ERCP)
研究者
C.Y. Ponsioen
Prof. Dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)