Study of New Imaging Criteria for the Diagnosis of Caroli... | NCT04007575

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

NCT04007575

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Nov 16, 2021Actual

Enrollment

61Actual

Phase

Not provided

Conditions

Caroli Disease
Magnetic Resonance Imaging
Cholangiopancreatography

Interventions

Magnetic Resonance CholangioPancreatography

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 18, 2020Actual

Primary Completion Date

Sep 1, 2020Actual

Completion Date

Dec 1, 2020Actual

First Submitted Date

Jun 4, 2019

First Submission Date that Met QC Criteria

Jul 2, 2019

First Posted Date

Jul 5, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2021

Last Update Posted Date

Nov 16, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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		Magnetic Resonance Imaging

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Pathological examination	Absence or presence of tumors	2 years
Pathological examination	Absence or presence of calculi	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with illness or Caroli syndrome

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
LEWIN MAITE, MD, PhD	Paul Brousse hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maite Lewin		Le Kremlin-Bicêtre		94804	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016767	Caroli Disease

Ancestor Terms

ID	Term
D015529	Choledochal Cyst
D001649	Bile Duct Diseases
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D049448	Cholangiopancreatography, Magnetic Resonance
D008279	Magnetic Resonance Imaging

Ancestor Terms

ID	Term
D014054	Tomography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided