International Registry of Congenital Portosystemic Shunt (IRCPSS)

Study Purpose

Congenital Portosystemic Shunt (CPSS) is a rare condition important by the multiplicity and severity of associated complications. CPSS is venous anomaly in which blood coming from the intestines only partially passes through the liver. This leads to the accumulation of potentially toxic factors that cause systemic effects. Complications vary among the individuals, and currently, it is challenging to predict which individuals will develop severe complications. The IRCPSS registry is established with the aim of centralizing detailed clinical follow-up and biological information from participants around the world who suffer from Congenital Portosystemic Shunt (CPSS). A multidisciplinary consortium of experts is collaborating to enhance our understanding of the prevalence, natural history, individual risks, and physiopathology of the disease through the IRCPSS registry.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 1 Day and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

Individual with CPSS.

Exclusion Criteria:

Secondary shunt without evidence of congenital shunt

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06041906
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Prof. Valérie Mc Lin
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Valérie A Mc Lin, Prof. Dr. med.
Principal Investigator Affiliation University Hospital, Geneva
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Enrolling by invitation
Countries Australia, Belgium, Canada, France, Germany, Hungary, India, Israel, Italy, Japan, Netherlands, Spain, Switzerland, Turkey (Türkiye), United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Congenital Portosystemic Shunt, CPSS (Congenital Portosystemic Shunt)
Study Website: View Trial Website
Arms & Interventions

Arms

: Neonate, Children, Adult with CPSS

Interventions

Procedure: - Shunt Closure

Consist in spontaneous, surgical or interventional closure of the shunt. Depending on context, surgical intervention may also be transplantation.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Yale University School of Medicine, New Haven 4839366, Connecticut 4831725

Status

Address

Yale University School of Medicine

New Haven 4839366, Connecticut 4831725, 06520

Lurie Children's Hospital, Chicago 4887398, Illinois 4896861

Status

Address

Lurie Children's Hospital

Chicago 4887398, Illinois 4896861, 60611

International Sites

Royal Children's Hospital Melbourne, Parkville 2153770, Victoria 2145234, Australia

Status

Address

Royal Children's Hospital Melbourne

Parkville 2153770, Victoria 2145234, 3052

Universitary Clinics Saint-Luc, UCL, Brussels 2800866, Belgium

Status

Address

Universitary Clinics Saint-Luc, UCL

Brussels 2800866, , 1200

The Hospital for Sick Children, Toronto 6167865, Ontario 6093943, Canada

Status

Address

The Hospital for Sick Children

Toronto 6167865, Ontario 6093943, M5G 1X8

Beaujon University Hospital, Clichy 3024597, France

Status

Address

Beaujon University Hospital

Clichy 3024597, , 92100

Le Kremlin-Bicêtre 3003737, France

Status

Address

Hôpital Bicêtre-Hôpitaux Universitaires Paris-Sud- Assistance Publique Hôpitaux de Paris.

Le Kremlin-Bicêtre 3003737, , 94275

Hôpital Necker, Paris 2988507, France

Status

Address

Hôpital Necker

Paris 2988507, , 75743

Hannover Medical School, Hanover 2910831, Germany

Status

Address

Hannover Medical School

Hanover 2910831, , 30625

Haunersche Kinderklinik - LMU Munich, Munich 2867714, Germany

Status

Address

Haunersche Kinderklinik - LMU Munich

Munich 2867714, , 80337

University of Tuebingen, Tübingen 2820860, Germany

Status

Address

University of Tuebingen

Tübingen 2820860, , 72076

Budapest 3054643, Hungary

Status

Address

First Department of Pediatrics, Semmelweis University

Budapest 3054643, , 1083

Amrita institute of Medical Sciences, Kochi 1273874, Kerala 1267254, India

Status

Address

Amrita institute of Medical Sciences

Kochi 1273874, Kerala 1267254, 682041

New Delhi 1261481, India

Status

Address

Department of Pediatric Hepatology Institute of Liver and Biliary Sciences

New Delhi 1261481, , 110070

Petach Tikvah, Israel

Status

Address

Schneider Children's Medical Center of Israel

Petach Tikvah, , 49202

Papa Giovanni XXIII Hospital, Bergamo 3182164, Italy

Status

Address

Papa Giovanni XXIII Hospital

Bergamo 3182164, , 24127

Children's Hospital Santobono, Naples 3172394, Italy

Status

Address

Children's Hospital Santobono

Naples 3172394, , 80129

Palermo 2523920, Italy

Status

Address

Istituto di Ricovero e Cura a Carattere Scientifico (ISMETT)

Palermo 2523920, , 90127

Tokyo 1850147, Japan

Status

Address

National Center for Child Health and Development

Tokyo 1850147, , 157-8535

Academic Medical Centre, Amsterdam 2759794, Netherlands

Status

Address

Academic Medical Centre

Amsterdam 2759794, , 1105

University Medical Center Groningen, Groningen 2755251, Netherlands

Status

Address

University Medical Center Groningen

Groningen 2755251, , 9700 RB

Hospital Clínic de Barcelona, Barcelona 3128760, Spain

Status

Address

Hospital Clínic de Barcelona

Barcelona 3128760, , 08036

Hôpitaux Universitaires de Geneve (HUG), Geneva 2660646, Canton of Geneva 2660645, Switzerland

Status

Address

Hôpitaux Universitaires de Geneve (HUG)

Geneva 2660646, Canton of Geneva 2660645, 1205

Gazi University, Faculty of Medicine, Yenimahalle 296954, Ankara 323784, Turkey (Türkiye)

Status

Address

Gazi University, Faculty of Medicine

Yenimahalle 296954, Ankara 323784, 06560

Birmingham Children's Hospital, Birmingham 2655603, United Kingdom

Status

Address

Birmingham Children's Hospital

Birmingham 2655603, , B4 6NH

Edinburgh 2650225, United Kingdom

Status

Address

Royal Hospital for Children and Young People

Edinburgh 2650225, , EH16 4TJ

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