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临床试验/NCT04007575
NCT04007575已完成不适用

Magnetic Resonance CholangioPancreatography Signs for the Diagnosis of Caroli Disease

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2020年3月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
61
试验地点
1
主要终点
Intra-hepatic bile duct dilatation

研究概览

简要总结

The Caroli disease is a very rare pathology that can be revealed early in childhood or in adulthood, whose diagnosis is based on Magnetic Resonance CholangioPancreatography, which shows the communication of these malformations with the rest of the biliary tree and allows to eliminate biliary stenosis. The radiologist has a central role in the diagnostic orientation between malformative intra-hepatic bile duct dilatation and obstructive benign or malignant intra-hepatic bile duct dilatation dilatation. However, imaging of Caroli disease is polymorphous and therefore subject to misinterpretation. The benefit of this research is to reduce diagnostic errors by highlighting imaging criteria specific to the Caroli disease

详细描述

The Magnetic Resonance CholangioPancreatography will have been performed in all patients using different Magnetic Resonance Imaging systems (Gyroscan Intera, Philips Medical Systems, Best in the Netherlands, Magnetom Avanto, Siemens Medical Solutions, and Signa Hdxt, General Electric Medical Systems) with a free-breathing three-dimensional high-spatial-resolution Fast Spin Echo sequence and/or a breath-hold two-dimensional single-shot sequence. Magnetic Resonance CholangioPancreatography may also include a Fast Spin Echo weighted T2-weighted sequence with fat-spectral saturation, a T1-weighted breath-suppressed gradient echo pulse sequence and a chemical shift sequence in phase and opposite phase, in the axial plane, and a weighted three-dimensional T1 saturated fat sequence after intravenous administration of gadolinium chelate. Images will be analyzed in consensus by two abdominal radiologists on a Picture Archiving and Communication System station and compared with the pathological results.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • were patients identified in the database of the hospitals who underwent
  • a diagnosis of Caroli disease on an imaging report with bile duct dilatation limited to the intrahepatic biliary tree and
  • an available Magnetic Resonance CholangioPancreatography on a Picture Archiving and Communication System.

排除标准

  • obstructive benign or malignant proximal biliary stricture on Magnetic Resonance CholangioPancreatography
  • prior surgical interventions for hepatobiliary disease except cholecystectomy

结局指标

主要结局

Intra-hepatic bile duct dilatation

时间窗: 2 years

signs of portal hypertension (qualitative measurement)

次要结局

  • Pathological examination(2 years)
  • Biology(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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