RecruitingNot ApplicableNCT05308628

Pediatric Liver Transplantation-Liver Fibrosis Evaluation by Using Fibrosis Panel

Effect of the Fibrosis Panel on the Evaluation of Allograft Fibrosis After Pediatric Liver Transplantation

Sponsor

RenJi Hospital

Enrollment

1,200 participants

Start Date

Apr 30, 2022

Study Type

INTERVENTIONAL

Conditions

Liver Transplant; Complications Liver Fibrosis Pediatric Disorder

Summary

Liver transplantation in children is highly successful with \>80% having 20 years survival. Most pediatric liver diseases are potentially curable with liver transplantation and it is important to establish whether children who have undergone successful transplantation can expect a normal life expectancy or whether there will be a gradual decline in liver function and eventual graft loss. The most common reasons in late graft loss in children are unexplained graft inflammation ("idiopathic" post-transplant hepatitis) and graft fibrosis. PRO-C3, a disintegrin and metalloproteinase with thrombospondin motifs-generated neo-epitope marker of type III collagen formation, has been proved to be a marker of fibrosis in patients with NAFLD. The aim of this study is to explore the role of Fibrosis Panel(PRO-C3, PIIINP, TIMP-1, HA) in children received liver transplantation.

Eligibility

Min Age: 2 MonthsMax Age: 18 Years

Inclusion Criteria4

Male or female participant must be between 8 weeks and 18 years of age.
Participant is a recipient of a first liver allograft from cadaveric or living donors.
Participant is a single-organ recipient (liver only).
Participants' parent/guardian is capable of understanding the purposes and risks of the study and must sign an informed consent for the study.

Exclusion Criteria8

Participants older than 18 years of age
Pregnant or breastfeeding
Active systemic infections
Receiving any form of solid organ retransplantation
Multiorgan transplantation
Multi organ failure
Congenital sufferers from heart, lung, kidney, nervous system or blood disease
Refused to participate the study

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTLiver Allograft Fibrosis by Using Fibrosis Panel(PRO-C3, PIIINP, TIMP-1, HA etc.)

Liver biopsies will be performed at 3 months, 6 months and 12 months post-transplant. Fibrosis was evaluated using the liver allograft fibrosis score (LAFSc) staging system. Liver Allograft Fibrosis by Using Fibrosis Panel(PRO-C3, PIIINP, TIMP-1, HA)or (FBLN3,YKL40,LECT2 etc.)