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

Recruiting

• Conditions: Liver Transplantation

• Registration Number: NCT06217965
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Study Timeline

• Study First Submitted: 2023-11-20
• Study Start: 2024-01-01
• Study First Submitted QC: 2024-01-11
• Study First Posted: 2024-01-23
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-29
• Last Update Posted: 2024-05-01
• Primary Completion: 2024-12
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
assessing the epidemiological and social impact of pediatric liver transplantation	1 year	To 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 Outcome Measures

Name	Time	Method
assessing their knowledge of their disease, their experience of the transition period from pediatrics to adult medicine, and their compliance with medication	1 year	to 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)

Trial Locations

Locations (1)

Avanie Hippocrate 10; 🇧🇪 Woluwe-Saint-Lambert, Bruxelles, Belgium