International Registry of Congenital Portosystemic Shunt (IRCPSS)

NCT ID: NCT06041906

Last Updated: 2025-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-26

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Congenital Portosystemic Shunt CPSS (Congenital Portosystemic Shunt)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Neonate, Children, Adult with CPSS

Shunt Closure

Intervention Type PROCEDURE

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

Interventions

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Shunt Closure

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Individual with CPSS

Exclusion Criteria

Secondary shunt without evidence of congenital shunt
Minimum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Society of Pediatric Gastroenterology, Hepatology and Nutrition

OTHER

Sponsor Role collaborator

European Association for the Study of the Liver (EASL)

UNKNOWN

Sponsor Role collaborator

Fondation Andrea Ferrari

UNKNOWN

Sponsor Role collaborator

Prof. Valérie Mc Lin

OTHER

Sponsor Role lead

Responsible Party

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Prof. Valérie Mc Lin

Prof. Dr. med.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Valérie A Mc Lin, Prof. Dr. med.

Role: STUDY_DIRECTOR

University Hospital, Geneva

Locations

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Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

Lurie Children's Hospital

Chicago, Illinois, United States

Site Status

Royal Children's Hospital Melbourne

Parkville, Victoria, Australia

Site Status

Universitary Clinics Saint-Luc, UCL

Brussels, , Belgium

Site Status

The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Beaujon University Hospital

Clichy, , France

Site Status

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

Le Kremlin-Bicêtre, , France

Site Status

Hôpital Necker

Paris, , France

Site Status

Hannover Medical School

Hanover, , Germany

Site Status

Haunersche Kinderklinik - LMU Munich

Munich, , Germany

Site Status

University of Tuebingen

Tübingen, , Germany

Site Status

First Department of Pediatrics, Semmelweis University

Budapest, , Hungary

Site Status

Amrita institute of Medical Sciences

Kochi, Kerala, India

Site Status

Department of Pediatric Hepatology Institute of Liver and Biliary Sciences

New Delhi, , India

Site Status

Schneider Children's Medical Center of Israel

Petach Tikvah, , Israel

Site Status

Papa Giovanni XXIII Hospital

Bergamo, , Italy

Site Status

Children's Hospital Santobono

Naples, , Italy

Site Status

Istituto di Ricovero e Cura a Carattere Scientifico (ISMETT)

Palermo, , Italy

Site Status

National Center for Child Health and Development

Tokyo, , Japan

Site Status

Academic Medical Centre

Amsterdam, , Netherlands

Site Status

University Medical Center Groningen

Groningen, , Netherlands

Site Status

Hospital Clínic de Barcelona

Barcelona, , Spain

Site Status

Hôpitaux Universitaires de Geneve (HUG)

Geneva, Canton of Geneva, Switzerland

Site Status

Gazi University, Faculty of Medicine

Yenimahalle, Ankara, Turkey (Türkiye)

Site Status

Birmingham Children's Hospital

Birmingham, , United Kingdom

Site Status

Royal Hospital for Children and Young People

Edinburgh, , United Kingdom

Site Status

Countries

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United States Australia Belgium Canada France Germany Hungary India Israel Italy Japan Netherlands Spain Switzerland Turkey (Türkiye) United Kingdom

References

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Hanquinet S, Morice C, Courvoisier DS, Cousin V, Anooshiravani M, Merlini L, McLin VA. Globus pallidus MR signal abnormalities in children with chronic liver disease and/or porto-systemic shunting. Eur Radiol. 2017 Oct;27(10):4064-4071. doi: 10.1007/s00330-017-4808-x. Epub 2017 Apr 6.

Reference Type BACKGROUND
PMID: 28386718 (View on PubMed)

Cudalbu C, McLin VA, Lei H, Duarte JM, Rougemont AL, Oldani G, Terraz S, Toso C, Gruetter R. The C57BL/6J mouse exhibits sporadic congenital portosystemic shunts. PLoS One. 2013 Jul 23;8(7):e69782. doi: 10.1371/journal.pone.0069782. Print 2013.

Reference Type BACKGROUND
PMID: 23936100 (View on PubMed)

Joye R, Lador F, Aggoun Y, Farhat N, Wacker J, Wildhaber BE, Vallee JP, Hachulla AL, McLin VA, Beghetti M. Outcome of paediatric portopulmonary hypertension in the modern management era: A case report of 6 patients. J Hepatol. 2021 Mar;74(3):742-747. doi: 10.1016/j.jhep.2020.11.039. Epub 2020 Dec 1.

Reference Type BACKGROUND
PMID: 33276028 (View on PubMed)

McLin V, Beghetti M, D'Antiga L, Franchi-Abella S; International Registry of Congenital Porto-Systemic Shunts (IRCPSS). Current Quandaries in the Management of Congenital Portosystemic Shunts. Liver Transpl. 2021 Aug;27(8):1212-1213. doi: 10.1002/lt.26055. Epub 2021 Jul 20. No abstract available.

Reference Type BACKGROUND
PMID: 33749116 (View on PubMed)

Korff S, Mostaguir K, Beghetti M, D'Antiga L, Debray D, Franchi-Abella S, Gonzales E, Guerin F, Hachulla AL, Lambert V, Makrythanasis P, Roduit N, Savale L, Senat MV, Spaltenstein J, van Steenbeek F, Wildhaber BE, Zwahlen M, McLin VA. International registry of congenital porto-systemic shunts: a multi-centre, retrospective and prospective registry of neonates, children and adults with congenital porto-systemic shunts. Orphanet J Rare Dis. 2022 Jul 19;17(1):284. doi: 10.1186/s13023-022-02412-8.

Reference Type BACKGROUND
PMID: 35854389 (View on PubMed)

Lambert V, Ladarre D, Fortas F, Durand P, Herve P, Gonzales E, Guerin F, Savale L, McLin VA, Ackermann O, Franchi-Abella S; International Registry of Congenital Portosystemic Shunts (IRCPSS). Cardiovascular disorders in patients with congenital portosystemic shunts: 23 years of experience in a tertiary referral centre. Arch Cardiovasc Dis. 2021 Mar;114(3):221-231. doi: 10.1016/j.acvd.2020.10.003. Epub 2020 Dec 3.

Reference Type BACKGROUND
PMID: 33281106 (View on PubMed)

McLin VA, D'Antiga L. The current pediatric perspective on type B and C hepatic encephalopathy. Anal Biochem. 2022 Apr 15;643:114576. doi: 10.1016/j.ab.2022.114576. Epub 2022 Jan 29.

Reference Type BACKGROUND
PMID: 35104444 (View on PubMed)

McLin VA, Franchi Abella S, Debray D, Guerin F, Beghetti M, Savale L, Wildhaber BE, Gonzales E; Members of the International Registry of Congenital Porto-Systemic Shunts. Congenital Portosystemic Shunts: Current Diagnosis and Management. J Pediatr Gastroenterol Nutr. 2019 May;68(5):615-622. doi: 10.1097/MPG.0000000000002263.

Reference Type BACKGROUND
PMID: 30628988 (View on PubMed)

Bahadori A, Kuhlmann B, Debray D, Franchi-Abella S, Wacker J, Beghetti M, Wildhaber BE, McLin VA, On Behalf Of The Ircpss. Presentation of Congenital Portosystemic Shunts in Children. Children (Basel). 2022 Feb 11;9(2):243. doi: 10.3390/children9020243.

Reference Type BACKGROUND
PMID: 35204963 (View on PubMed)

Guerin F, Franchi Abella S, McLin V, Ackermann O, Girard M, Cervoni JP, Savale L, Hernandez-Gea V, Valla D, Hillaire S, Dutheil D, Bureau C, Gonzales E, Plessier A. Congenital portosystemic shunts: Vascular liver diseases: Position papers from the francophone network for vascular liver diseases, the French Association for the Study of the Liver (AFEF), and ERN-rare liver. Clin Res Hepatol Gastroenterol. 2020 Sep;44(4):452-459. doi: 10.1016/j.clinre.2020.03.004. Epub 2020 Apr 9. No abstract available.

Reference Type BACKGROUND
PMID: 32279979 (View on PubMed)

Rock NM, Beghetti M, Tissot C, Willi JP, Bouhabib M, McLin VA, Maggio ABR. Reliable Detection of Intrapulmonary Shunts Using Contrast-Enhanced Echocardiography in Children With Portal Hypertension or Portosystemic Shunt. J Pediatr Gastroenterol Nutr. 2021 Jul 1;73(1):73-79. doi: 10.1097/MPG.0000000000003079.

Reference Type BACKGROUND
PMID: 33605662 (View on PubMed)

Related Links

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https://ircpss.com/

International Registry of Congenital Portosystemic Shunts website, for patients and professionals

Other Identifiers

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2018-00413

Identifier Type: -

Identifier Source: org_study_id

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