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Study of New Imaging Criteria for the Diagnosis of Caroli's Disease

Magnetic Resonance CholangioPancreatography Signs for the Diagnosis of Caroli Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04007575
Acronym
IMACA
Enrollment
61
Registered
2019-07-05
Start date
2020-03-18
Completion date
2020-12-01
Last updated
2021-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caroli Disease, Magnetic Resonance Imaging, Cholangiopancreatography

Brief summary

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

Detailed description

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.

Interventions

The imaging data will be collected from the hospital records and image archiving system of the radiology departments of the University Hospitals

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Intra-hepatic bile duct dilatation2 yearsstudy of intra-hepatic bile duct shape (qualitative measurement)

Secondary

MeasureTime frameDescription
Pathological examination2 yearsAbsence or presence of tumors
Biology2 yearsbilirubin level

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026