International Registry of Congenital Portosystemic Shunt (IRCPSS) (NCT06041906) | Clinical Trial Compass
By InvitationNot Applicable
International Registry of Congenital Portosystemic Shunt (IRCPSS)
United States, Australia, Belgium500 participantsStarted 2018-04-26
Plain-language summary
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.
Who can participate
Age range
1 Day
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Individual with CPSS
Exclusion Criteria:
Secondary shunt without evidence of congenital shunt
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a registry study that tracks what naturally happens to patients with congenital portosystemic shunts — including whether shunts close on their own or cause complications — could joining this registry help my care team learn from how other patients with the same condition have been managed?
2The registry is tracking whether some patients' shunts close spontaneously without intervention, while others need preemptive closure — based on my specific situation, which path does my doctor think is most likely for me?
3Because this is listed as 'enrolling by invitation,' how would I or my child actually get referred to participate, and is my current medical center connected to this international registry?
4Since this is an observational registry rather than a treatment trial, what exactly would participation involve for us in terms of follow-up visits, data sharing, or any additional tests beyond what my normal care requires?
5Are there any standard treatment guidelines for congenital portosystemic shunts that my doctor would recommend following regardless of whether we join this registry, and would being in the registry change any of those decisions?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Numbers of patients with spontaneous shunt closure
Timeframe: 3; 6; 12; 24 months
2
Number of patients developing one or more complications