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

NCT ID: NCT04007575

Last Updated: 2021-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-18

Study Completion Date

2020-12-01

Brief Summary

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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

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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.

Conditions

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Caroli Disease Magnetic Resonance Imaging Cholangiopancreatography

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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Magnetic Resonance CholangioPancreatography

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Magnetic Resonance Imaging

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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LEWIN MAITE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Paul Brousse hospital

Locations

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Maite Lewin

Le Kremlin-Bicêtre, , France

Site Status

Countries

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France

Other Identifiers

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APHP190470

Identifier Type: -

Identifier Source: org_study_id