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

NCT ID: NCT06217965

Last Updated: 2024-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-10-31

Brief Summary

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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

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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.

Conditions

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Liver Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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survey

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xavier Stephenne, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

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Avanie Hippocrate 10

Woluwe-Saint-Lambert, Brussels Capital, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Xavier Stephenne, MD, PhD

Role: CONTACT

+3227641377

Clara Gautier, MD

Role: CONTACT

+3227641352

Facility Contacts

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Xavier Stephenne

Role: primary

clara Gautier

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 18582779 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28918383 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22192813 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 35868688 (View on PubMed)

Other Identifiers

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2023/06DEC/498

Identifier Type: -

Identifier Source: org_study_id

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