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Histologic Evolution of Patients With Liver Transplantation

NCT06103097 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2023-10-26

No results posted yet for this study

Summary

Certain pediatric liver transplant patients with immunosuppression levels in the therapeutic range and normal liver function tests present histological alterations (inflammation or fibrosis) in protocol biopsies.

The objective of the study was to evaluate the histological findings of protocol biopsies performed at 2, 5, 10 and 15 years after liver transplantation in pediatric patients. A follow-up biopsy is also performed 1 and 3 years after liver rejection.

To do that, a cohort study will be carried out by collecting clinical, analytical and histological data of patients undergoing post-liver transplant follow-up in pediatric hepatology and liver transplant outpatient clinics. According to the follow-up protocol for these patients, a liver biopsy is performed at 2, 5, 10 and 15 years after the transplant. In addition, ultrasound, elastography and general analysis with autoimmunity and HLA studies are carried out.

The evaluation of the histological evolution of the liver graft and its relationship with clinical and analytical changes will favor the management of immunosuppressive treatment in pediatric patients with liver transplants.

Conditions

  • Liver Transplant Failure and Rejection
  • Children, Only

Interventions

OTHER

No interventions done (obervational)

Observational study

Sponsors & Collaborators

  • Spanish Society of Pediatric Gastroenterology, Hepatology and Nutrition

    collaborator UNKNOWN

  • Hospital Vall d'Hebron

    lead OTHER

Principal Investigators

  • Jesus Quintero, MD · Responsible of Pediatric Hepatology and Liver Transplant Department

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-15
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06103097 on ClinicalTrials.gov