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

Liver Transplantation Clinical Trial

— EPsyGraft  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06217965
• Other study ID #: 2023/06DEC/498
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: October 2025

Study information

• Verified date: April 2024
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Xavier Stephenne, MD, PhD
• Phone: +3227641377
• Email: xavier.stephenne[@]saintluc.uclouvain.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

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

Locations

Country	Name	City	State
Belgium	Avanie Hippocrate 10	Woluwe-Saint-Lambert	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

References & Publications (4)

Dommergues JP, Letierce A, Descots C, Debray D. [Medical follow-up, everyday life and actual experience of young adults after liver transplantation in childhood]. Arch Pediatr. 2008 Jun;15(5):855-6. doi: 10.1016/S0929-693X(08)71940-7. No abstract available. French. — View Citation

Kohli R, Cortes M, Heaton ND, Dhawan A. Liver transplantation in children: state of the art and future perspectives. Arch Dis Child. 2018 Feb;103(2):192-198. doi: 10.1136/archdischild-2015-310023. Epub 2017 Sep 16. — View Citation

Ng VL, Alonso EM, Bucuvalas JC, Cohen G, Limbers CA, Varni JW, Mazariegos G, Magee J, McDiarmid SV, Anand R; Studies of Pediatric Liver Transplantation (SPLIT) Research Group. Health status of children alive 10 years after pediatric liver transplantation performed in the US and Canada: report of the studies of pediatric liver transplantation experience. J Pediatr. 2012 May;160(5):820-6.e3. doi: 10.1016/j.jpeds.2011.10.038. Epub 2011 Dec 20. — View Citation

Smith SK, Miloh T. Pediatric Liver Transplantation. Clin Liver Dis. 2022 Aug;26(3):521-535. doi: 10.1016/j.cld.2022.03.010. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessing the epidemiological and social impact of pediatric liver transplantation	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)	1 year
Secondary	assessing their knowledge of their disease, their experience of the transition period from pediatrics to adult medicine, and their compliance with medication	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)	1 year