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

Magnetic Resonance Imaging Clinical Trial

— IMACA  

Official title:

Magnetic Resonance CholangioPancreatography Signs for the Diagnosis of Caroli Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04007575
• Other study ID #: APHP190470
• Status: Completed
• Start date: March 18, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: November 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Caroli Disease
• Cholangiopancreatography
• Magnetic Resonance Imaging

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
France	Maite Lewin	Le Kremlin-Bicêtre

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra-hepatic bile duct dilatation	study of intra-hepatic bile duct shape (qualitative measurement)	2 years
Primary	Intra-hepatic bile duct dilatation	intra-hepatic bile duct localisation (qualitative measurement)	2 years
Primary	Intra-hepatic bile duct dilatation	biliary calculi (qualitative measurement)	2 years
Primary	Intra-hepatic bile duct dilatation	dot sign (qualitative measurement)	2 years
Primary	Intra-hepatic bile duct dilatation	liver abnormalities (qualitative measurement)	2 years
Primary	Intra-hepatic bile duct dilatation	signs of portal hypertension (qualitative measurement)	2 years
Secondary	Pathological examination	Absence or presence of tumors	2 years
Secondary	Pathological examination	Absence or presence of calculi	2 years
Secondary	Biology	bilirubin level	2 years
Secondary	Biology	Alkaline phosphatase level	2 years
Secondary	Biology	Creatinine level	2 years