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

Completed

• Conditions: Cholangiopancreatography; Magnetic Resonance Imaging; Caroli Disease

• Registration Number: NCT04007575
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2019-06-04
• Study First Submitted QC: 2019-07-02
• Study First Posted: 2019-07-05
• Study Start: 2020-03-18
• Primary Completion: 2020-09-01
• Study Completion: 2020-12-01
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-15
• Last Update Posted: 2021-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intra-hepatic bile duct dilatation	2 years	signs of portal hypertension (qualitative measurement)

Secondary Outcome Measures

Name	Time	Method
Pathological examination	2 years	Absence or presence of calculi
Biology	2 years	Creatinine level

Trial Locations

Locations (1)

Maite Lewin; 🇫🇷 Le Kremlin-Bicêtre, France