Evaluating liver health in pediatric transplant patients over time
"Assessment of the Histological Evolution of Pediatric Patients With Liver Transplantation"
This study looks at how the livers of kids who have had a transplant change over time to see if there are any problems, even when their liver tests look normal.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 2 Years to 18 Years |
| Sex | All |
| Sponsor | Hospital Vall d'Hebron Academic / other |
| Locations | 1 site (Barcelona, Catalunya) |
| Trial ID | NCT06103097 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the histological changes in liver biopsies of pediatric patients who have undergone liver transplantation. It involves collecting clinical, analytical, and histological data from patients at various follow-up intervals (2, 5, 10, and 15 years post-transplant). The study will analyze biopsies to identify any inflammation or fibrosis despite normal liver function tests and therapeutic immunosuppression levels. Additionally, ultrasound and elastography will be utilized to monitor liver health.
Who should consider this trial
Good fit: Ideal candidates are children aged 2-18 years who have received a liver transplant at least two years prior and are undergoing regular follow-up at the Vall d'Hebron Hospital.
Not a fit: Patients who do not meet the inclusion criteria or those who have received multiple organ transplants may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve long-term management and outcomes for pediatric liver transplant patients by identifying histological changes that may indicate complications.
How similar studies have performed: While there have been studies on liver transplant outcomes, this specific focus on long-term histological changes in pediatric patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients between 2-18 years old who have received a liver transplant at least two years ago * Follow-up in pediatric hepatology and liver transplant outpatient clinics at the Vall d'Hebron Hospital * Performing tests, ultrasound, elastography and biopsy during the last year as part of the follow-up protocol of our center * Patients who have signed the informed consent for inclusion in the study and the corresponding assents. Exclusion Criteria: * Patients who do not meet all the inclusion criteria of the protocol. * Patients who are transplant recipients of multiple solid organs.
Where this trial is running
Barcelona, Catalunya
- Hospital Universitari Vall d'Hebron — Barcelona, Catalunya, Spain (Recruiting)
Study contacts
- Principal investigator: Jesus Quintero, MD — Responsible of Pediatric Hepatology and Liver Transplant Department
- Study coordinator: Jesus Quintero, MD
- Email: jesus.quintero@vallhebron.cat
- Phone: 0034 934893000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.