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

NCT04007575 | Completed

• 1 other identifier: APHP190470
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

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

Conditions

Caroli Disease; Magnetic Resonance Imaging; Cholangiopancreatography

Outcome Measures

Primary Outcomes (6)

• Intra-hepatic bile duct dilatation

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

  2 years

• Intra-hepatic bile duct dilatation

  intra-hepatic bile duct localisation (qualitative measurement)

  2 years

• Intra-hepatic bile duct dilatation

  biliary calculi (qualitative measurement)

  2 years

• Intra-hepatic bile duct dilatation

  dot sign (qualitative measurement)

  2 years

• Intra-hepatic bile duct dilatation

  liver abnormalities (qualitative measurement)

  2 years

• Intra-hepatic bile duct dilatation

  signs of portal hypertension (qualitative measurement)

  2 years

Secondary Outcomes (5)

• Pathological examination

  2 years

• Pathological examination

  2 years

• Biology

  2 years

• Biology

  2 years

• Biology

  2 years

Interventions

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

Also known as: Magnetic Resonance Imaging

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with illness or Caroli syndrome

You may qualify if:

• 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.

You may not qualify if:

• obstructive benign or malignant proximal biliary stricture on Magnetic Resonance CholangioPancreatography
• prior surgical interventions for hepatobiliary disease except cholecystectomy

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Maite Lewin

Le Kremlin-Bicêtre, 94804, France

Location

MeSH Terms

Conditions

Caroli Disease

Interventions

Cholangiopancreatography, Magnetic Resonance; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Choledochal Cyst; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Digestive System Abnormalities; Ciliopathies; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System

Study Officials

• LEWIN MAITE, MD, PhD

  Paul Brousse hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: July 5, 2019
• Study Start: March 18, 2020
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: November 16, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)