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Evaluation of the Epidemiological and Psychosocial Outcomes of Liver Graft Recipients Transplanted During Childhood

Evaluation of the Epidemiological and Psychosocial Outcomes of Liver Graft Recipients Transplanted During Childhood

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06217965
Acronym
EPsyGraft
Enrollment
100
Registered
2024-01-23
Start date
2024-01-01
Completion date
2025-10-31
Last updated
2024-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplantation

Brief summary

The main objective of this study is to better characterize the adult population with a history of liver transplantation in pediatric age. In this context, the investigators will use a questionnaire to assess the participants social environment and lifestyle habits and validated scales to assess their alcohol consumption and anxiety levels. Secondly, the investigators would like to assess the participants knowledge of their disease, their experience of the transition period from pediatrics to adult medicine, and their compliance with medication.

Detailed description

Outcomes after pediatric liver transplantation have improved in recent years, thanks to improvements in surgical techniques, immunosuppressive drugs and postoperative management in pediatric hepatology departments. For some diseases, transplantation has become the only way to save the lives of these children, or to ensure them a better quality of life. Indications for pediatric liver transplantation can be categorized as follows: Cholestatic condition, hepatitis, metabolic diseases, tumors and orther conditions such as Gestational alloimmune liver disease, drug induced liver diseases, ect. Short- and long-term complications following liver transplantation have been the subject of numerous studies. These include mainly biliary and vascular complications, rejection and infections (including EBV viral infections, which can lead to post-transplant lymphoproliferative disorder). A recent study showed that in the long term, only 32% of children with liver transplants had an ideal outcome defined as a first allograft stable on immunosuppression monotherapy, normal growth, and absence of common immunosuppression-induced sequelae. However, there are few studies on the epidemiological and social outcome of pediatric liver transplantation. Our French colleagues have published in 2008 one of the few studies on the subject, which reports notably that young adults with a history of liver transplants in paediatric age were anxious about their future, had lower alcohol consumption than the general population, but that medication compliance remained a challenge to be improved. The aim of our research project is to broaden our knowledge of the subject by assessing the epidemiological and social impact of pediatric liver transplantation on French-speaking liver transplant patients followed at the Cliniques Universitaires Saint Luc. Objective data on these points will enable us to reinforce our prevention and social support measures, and to review our transfer protocols from pediatric to adult medicine.

Interventions

OTHERsurvey

The study will involve patients completing a questionnaire on a secure online platform (such as RedCap)

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Any patient over 18 years old who received a pediatric liver transplant and who have been followed regularly at the Saint-Luc university clinics is eligible for inclusion in this study provided they speak French/Dutch fluently

Exclusion criteria

* patients minor (\< 18 years)

Design outcomes

Primary

MeasureTime frameDescription
assessing the epidemiological and social impact of pediatric liver transplantation1 yearTo better characterize the adult population with a history of liver transplantation in pediatric age. In this context, we will use a questionnaire to assess : * social environment (level of education, social status, employment, sexual orientation...) * lifestyle habits (risk-taking behavior, diet, exercise, weight, height…) * validated scales to assess their alcohol consumption and anxiety levels (AUDIT, BDI, STAI)

Secondary

MeasureTime frameDescription
assessing their knowledge of their disease, their experience of the transition period from pediatrics to adult medicine, and their compliance with medication1 yearto assess by questionnaire their knowledge of : * their disease (name, mechanism…) * their experience of the transition period from pediatrics to adult medicine (âge, personal experience…) * their compliance with medication (number of treatments, gradation of compliance by type of treatment)

Countries

Belgium

Contacts

Primary ContactXavier Stephenne, MD, PhD
xavier.stephenne@saintluc.uclouvain.be+3227641377
Backup ContactClara Gautier, MD
clara.gautier@saintluc.uclouvain.be+3227641352

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026