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Completed

NCT Number: NCT04007575

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

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

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Key information

Conditions

Caroli Disease Abnormalities, Multiple Bile Duct Diseases Biliary Tract Diseases Cholangiopancreatography Choledochal Cyst Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases Genetic Diseases, Inborn Magnetic Resonance Imaging

Sex eligibility

All sexes

Study type

Observational

Primary location

Maite Lewin

Le Kremlin-Bicêtre, 94804, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance Cholangiopancreatography

Diagnostic Test

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

Other names: Magnetic Resonance Imaging

Primary outcomes

  1. Intra-hepatic bile duct dilatation

    Time frame: 2 years

    study of intra-hepatic bile duct shape (qualitative measurement)

  2. Intra-hepatic bile duct dilatation

    Time frame: 2 years

    intra-hepatic bile duct localisation (qualitative measurement)

  3. Intra-hepatic bile duct dilatation

    Time frame: 2 years

    biliary calculi (qualitative measurement)

  4. Intra-hepatic bile duct dilatation

    Time frame: 2 years

    dot sign (qualitative measurement)

  5. Intra-hepatic bile duct dilatation

    Time frame: 2 years

    liver abnormalities (qualitative measurement)

  6. Intra-hepatic bile duct dilatation

    Time frame: 2 years

    signs of portal hypertension (qualitative measurement)

Secondary outcomes

  1. Pathological examination

    Time frame: 2 years

    Absence or presence of tumors

  2. Pathological examination

    Time frame: 2 years

    Absence or presence of calculi

  3. Biology

    Time frame: 2 years

    bilirubin level

  4. Biology

    Time frame: 2 years

    Alkaline phosphatase level

  5. Biology

    Time frame: 2 years

    Creatinine level

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Magnetic Resonance CholangioPancreatography Signs for the Diagnosis of Caroli Disease

Acronym: IMACA

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 5, 2019
Registry last updated
Nov 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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