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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04007575
Recruitment Status : Not yet recruiting
First Posted : July 5, 2019
Last Update Posted : January 21, 2020
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Caroli Disease Magnetic Resonance Imaging Cholangiopancreatography Diagnostic Test: Magnetic Resonance CholangioPancreatography

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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Magnetic Resonance CholangioPancreatography Signs for the Diagnosis of Caroli Disease
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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
    Other Name: Magnetic Resonance Imaging


Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with illness or Caroli syndrome
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04007575


Contacts
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Contact: LEWIN MAITE, MD, PhD 00 (33) 6 11 15 06 17 maite.lewin@aphp.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: LEWIN MAITE, MD, PhD Paul Brousse hospital

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04007575    
Other Study ID Numbers: APHP190470
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Caroli Disease
Choledochal Cyst
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Digestive System Abnormalities
Ciliopathies
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn