Assessment of the Histological Evolution of Pediatric Patients With Liver Transplantation

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Contact Information
Primary
Jesus Quintero, MD
jesus.quintero@vallhebron.cat
0034 934893000
Backup
Maria Mercadal-Hally, MD
mariamargaret.mercadal@vallhebron.cat
0034 675781547
Time Frame
Start Date: 2019-03-15
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 200
Treatments
Chohort of pediatric Liver transplant pacients
Patients under 18 years recipient of a Liver transplanbt followed in our Unit and under the follow-up liver biopsy protocol
Related Therapeutic Areas
Sponsors
Collaborators: Spanish Society of Pediatric Gastroenterology, Hepatology and Nutrition
Leads: Hospital Vall d'Hebron

This content was sourced from clinicaltrials.gov