Register a trial

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06041906




Registration number
NCT06041906
Ethics application status
Date submitted
11/09/2023
Date registered
18/09/2023

Titles & IDs
Public title
International Registry of Congenital Portosystemic Shunt (IRCPSS)
Scientific title
International Registry of Congenital Portosystemic Shunts (IRCPSS) - A Multi-centre, Retrospective and Prospective Registry of Neonates, Children and Adults With Congenital Portosystemic Shunts
Secondary ID [1] 0 0
2018-00413
Universal Trial Number (UTN)
Trial acronym
IRCPSS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congenital Porto-Systemic Shunt (CPSS) 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - Shunt Closure

Neonate, Children, Adult with CPSS -


Treatment: Surgery: Shunt Closure
Consist in spontaneous, surgical or interventional closure of the shunt. Depending on context, surgical intervention may also be transplantation.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Numbers of patients with spontaneous shunt closure
Timepoint [1] 0 0
3; 6; 12; 24 months
Primary outcome [2] 0 0
Number of patients developing one or more complications
Timepoint [2] 0 0
5; 10; 20 years
Primary outcome [3] 0 0
Number of patients undergoing preemptive closure
Timepoint [3] 0 0
6; 12; 24 months

Eligibility
Key inclusion criteria
Individual with CPSS
Minimum age
1 Day
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Secondary shunt without evidence of congenital shunt

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2028
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Children's Hospital Melbourne - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
Belgium
State/province [2] 0 0
Brussels
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
France
State/province [4] 0 0
Clichy
Country [5] 0 0
France
State/province [5] 0 0
Le Kremlin-Bicêtre
Country [6] 0 0
France
State/province [6] 0 0
Paris
Country [7] 0 0
Germany
State/province [7] 0 0
Munich
Country [8] 0 0
Germany
State/province [8] 0 0
Tuebingen
Country [9] 0 0
Greece
State/province [9] 0 0
Athens
Country [10] 0 0
Greece
State/province [10] 0 0
Chaidari
Country [11] 0 0
Hungary
State/province [11] 0 0
Budapest
Country [12] 0 0
India
State/province [12] 0 0
New Delhi
Country [13] 0 0
Israel
State/province [13] 0 0
Petach Tikvah
Country [14] 0 0
Italy
State/province [14] 0 0
Naples
Country [15] 0 0
Italy
State/province [15] 0 0
Palermo
Country [16] 0 0
Japan
State/province [16] 0 0
Tokyo
Country [17] 0 0
Netherlands
State/province [17] 0 0
Amsterdam
Country [18] 0 0
Netherlands
State/province [18] 0 0
Groningen
Country [19] 0 0
Spain
State/province [19] 0 0
Barcelona
Country [20] 0 0
Switzerland
State/province [20] 0 0
GE
Country [21] 0 0
Turkey
State/province [21] 0 0
Ankara
Country [22] 0 0
Turkey
State/province [22] 0 0
Istanbul
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Birmingham
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Edinburgh
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Leeds
Country [26] 0 0
United Kingdom
State/province [26] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Prof. Valérie Mc Lin
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
European Society of Pediatric Gastroenterology, Hepatology and Nutrition
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
European Association for the Study of the Liver (EASL)
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Fondation Andrea Ferrari
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Valérie A Mc Lin, Prof. Dr. med.
Address 0 0
University Hospital, Geneva
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
undecided


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06041906