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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Transplantation
• Intervention / Treatment: Other: survey

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Xavier Stephenne, MD, PhD; Phone Number: +3227641377; Email: xavier.stephenne@saintluc.uclouvain.be
• Study Contact Backup: Name: Clara Gautier, MD; Phone Number: +3227641352; Email: clara.gautier@saintluc.uclouvain.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of patients who received liver transplants before the age of 18 (pediatric transplants) and who have been followed regularly at Cliniques universitaires Saint-Luc. These patients must speak French or Dutch.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessing their knowledge of their disease, their experience of the transition period from pediatrics to adult medicine, and their compliance with medication	to assess 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

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Investigators: Principal Investigator: Xavier Stephenne, MD, PhD, Cliniques Universitaires Saint-Luc

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: November 20, 2023
• First Submitted That Met QC Criteria: January 11, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: EPsyGraft

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No