Caroli DiseaseIMACANCT04007575
Study of New Imaging Criteria for the Diagnosis of Caroli's Disease
An observational study of Caroli Disease and Magnetic Resonance Imaging, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Caroli Disease, Magnetic Resonance Imaging, Cholangiopancreatography
- What is being tested?
- Magnetic Resonance CholangioPancreatography
- How many people
- 61 participants
- Where
- 1 siteFrance
- Study dates
- 18 Mar 2020to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with illness or Caroli syndrome
Who may be able to join
- 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.
Who cannot join
- obstructive benign or malignant proximal biliary stricture on Magnetic Resonance CholangioPancreatography
- prior surgical interventions for hepatobiliary disease except cholecystectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Magnetic Resonance CholangioPancreatography Signs for the Diagnosis of Caroli 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
Read the 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.
- Being tested
- Magnetic Resonance CholangioPancreatography
- Medical subject headings
- Caroli Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance CholangioPancreatographyDiagnostic test
Also called Magnetic Resonance Imaging
The imaging data will be collected from the hospital records and image archiving system of the radiology departments of the University Hospitals
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-hepatic bile duct dilatation
study of intra-hepatic bile duct shape (qualitative measurement)
Measured: 2 years
Intra-hepatic bile duct dilatation
intra-hepatic bile duct localisation (qualitative measurement)
Measured: 2 years
Intra-hepatic bile duct dilatation
biliary calculi (qualitative measurement)
Measured: 2 years
Intra-hepatic bile duct dilatation
dot sign (qualitative measurement)
Measured: 2 years
Intra-hepatic bile duct dilatation
liver abnormalities (qualitative measurement)
Measured: 2 years
Intra-hepatic bile duct dilatation
signs of portal hypertension (qualitative measurement)
Measured: 2 years
Secondary outcomes (5)
Pathological examination
Absence or presence of tumors
Measured: 2 years
Pathological examination
Absence or presence of calculi
Measured: 2 years
Biology
bilirubin level
Measured: 2 years
Biology
Alkaline phosphatase level
Measured: 2 years
Biology
Creatinine level
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start18 Mar 2020
- Primary completion1 Sep 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caroli DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LEWIN MAITE, MD, PhD, Principal investigator, Paul Brousse hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007575
- Sponsor's protocol ID
- APHP190470
- Acronym
- IMACA
- Status last verified
- Nov 2021
- First submitted
- 4 Jun 2019
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance CholangioPancreatography Signs for the Diagnosis of Caroli Disease
- ClinicalTrials.gov ID
- NCT04007575
- Acronym / sponsor ID
- IMACA / APHP190470
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 18 Mar 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with illness or Caroli syndrome
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- obstructive benign or malignant proximal biliary stricture on Magnetic Resonance CholangioPancreatography
- prior surgical interventions for hepatobiliary disease except cholecystectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance CholangioPancreatographyAlso: Magnetic Resonance ImagingThe imaging data will be collected from the hospital records and image archiving system of the radiology departments of the University Hospitals | Diagnostic test | – |
Primary outcome
Intra-hepatic bile duct dilatation
Time frame: 2 years
study of intra-hepatic bile duct shape (qualitative measurement)
Intra-hepatic bile duct dilatation
Time frame: 2 years
intra-hepatic bile duct localisation (qualitative measurement)
Intra-hepatic bile duct dilatation
Time frame: 2 years
biliary calculi (qualitative measurement)
Intra-hepatic bile duct dilatation
Time frame: 2 years
dot sign (qualitative measurement)
Intra-hepatic bile duct dilatation
Time frame: 2 years
liver abnormalities (qualitative measurement)
Intra-hepatic bile duct dilatation
Time frame: 2 years
signs of portal hypertension (qualitative measurement)
5 secondary outcomes
Pathological examination
Time frame: 2 years
Pathological examination
Time frame: 2 years
Biology
Time frame: 2 years
Biology
Time frame: 2 years
Biology
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for Caroli Disease
RecruitingObservational study
ARPKD Database Study
Hepato/Renal Fibrocystic Disease, Autosomal Recessive Polycystic Kidney Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LEWIN MAITE, MD, PhD principal investigator
Paul Brousse hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caroli Disease and Magnetic Resonance Imaging, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-hepatic bile duct dilatation (time frame: 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.