Histologic Evolution of Patients With Liver Transplantation

NCT06103097 | Unknown DMC

• 1 other identifier: PR(AMI)511/2018
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Liver Histology; Follow-up Liver Biopsy

Outcome Measures

Primary Outcomes (1)

• Sublcinical inflamation

  Patients with normal liver function tests and RAI \> 2 in the follow-up liver biopsy

  From 15 March 2019 to 31 december 2024

Secondary Outcomes (2)

• Fibrosis

  From 15 March 2019 to 31 december 2024

• Sublcinical inflamation modification

  From 15 March 2020 to 31 december 2024

Study Arms (1)

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

Other: No interventions done (obervational)

Interventions

No interventions done (obervational) OTHER

Observational study

Chohort of pediatric Liver transplant pacients

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

\- Patients under 18 years of age who have received an isolated liver transplant and who are currently being monitored in the Pediatric Liver Transplant Unit of the Vall d'Hebron University Hospital

You may qualify if:

• 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

You may not qualify if:

• Patients who are transplant recipients of multiple solid organs.

Sponsors & Collaborators

• Hospital Vall d'Hebron: lead
• Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion Pediatrica: collaborator

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, Catalonia, 08035, Spain

RECRUITING

Related Publications (4)

• Muiesan P, Vergani D, Mieli-Vergani G. Liver transplantation in children. J Hepatol. 2007 Feb;46(2):340-8. doi: 10.1016/j.jhep.2006.11.006. Epub 2006 Dec 1.

  PMID: 17161491 RESULT

• Feng S. Long-term management of immunosuppression after pediatric liver transplantation: is minimization or withdrawal desirable or possible or both? Curr Opin Organ Transplant. 2008 Oct;13(5):506-12. doi: 10.1097/MOT.0b013e328310b0f7.

  PMID: 19060534 RESULT

• Feng S, Ekong UD, Lobritto SJ, Demetris AJ, Roberts JP, Rosenthal P, Alonso EM, Philogene MC, Ikle D, Poole KM, Bridges ND, Turka LA, Tchao NK. Complete immunosuppression withdrawal and subsequent allograft function among pediatric recipients of parental living donor liver transplants. JAMA. 2012 Jan 18;307(3):283-93. doi: 10.1001/jama.2011.2014.

  PMID: 22253395 RESULT

• Feng S, Demetris AJ, Spain KM, Kanaparthi S, Burrell BE, Ekong UD, Alonso EM, Rosenthal P, Turka LA, Ikle D, Tchao NK. Five-year histological and serological follow-up of operationally tolerant pediatric liver transplant recipients enrolled in WISP-R. Hepatology. 2017 Feb;65(2):647-660. doi: 10.1002/hep.28681. Epub 2016 Jul 27.

  PMID: 27302659 RESULT

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Jesus Quintero, MD

  Responsible of Pediatric Hepatology and Liver Transplant Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesus Quintero, MD

CONTACT

0034 934893000; jesus.quintero@vallhebron.cat

Maria Mercadal-Hally, MD

CONTACT

0034 675781547; mariamargaret.mercadal@vallhebron.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead Clinician; Pediatric Hepatology and Liver Transplant Department

Study Record Dates

• First Submitted: October 15, 2023
• First Posted: October 26, 2023
• Study Start: March 15, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)