About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Participants older than 18 years of age

Pregnant or breastfeeding

Active systemic infections

Receiving any form of solid organ retransplantation

Trial design

Design model

Crossover

Treatments tested in this trial

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

Treatment groups

1,200 Participants

are divided into 2 treatment groups

Group A: Post-Transplant-Liver Allograft FibrosisActive comparator 1 intervention

Group B: Post-Transplant-Liver Allograft regular recoverySham comparator 1 intervention

Trial outcomes

Primary outcomes

1

liver allograft fibrosis score (LAFSc) staging system(12 months)

Fibrosis deposition was classified in three main areas of the liver parenchyma: portal tracts, sinusoids (zones 1 and 2) and centrolobular veins (zone 3); in each area, fibrosis was staged from 0 to 3 (0 = absent, 1 = mild, 2 = moderate and 3 = severe fibrosis), with a total score of 9. Equal score weight was assigned to each area\] and the Ishak staging system (0 = no fibrosis; 1 = fibrous expansion of some portal area; 2 = fibrous expansion of most portal areas; 3 = fibrous expansion of most portal areas with occasional bridging; 4 = fibrous expansion of most portal areas with marked bridging; 5 = marked bridging occasional nodules; and 6 = cirrhosis

Time frame

12 months post-transplant

Secondary outcomes

1

liver allograft fibrosis score (LAFSc) staging system(6 months)

Fibrosis deposition was classified in three main areas of the liver parenchyma: portal tracts, sinusoids (zones 1 and 2) and centrolobular veins (zone 3); in each area, fibrosis was staged from 0 to 3 (0 = absent, 1 = mild, 2 = moderate and 3 = severe fibrosis), with a total score of 9. Equal score weight was assigned to each area\] and the Ishak staging system (0 = no fibrosis; 1 = fibrous expansion of some portal area; 2 = fibrous expansion of most portal areas; 3 = fibrous expansion of most portal areas with occasional bridging; 4 = fibrous expansion of most portal areas with marked bridging; 5 = marked bridging occasional nodules; and 6 = cirrhosis

Time frame

6 months post-transplant

Pediatric Liver Transplantation-Liver Fibrosis Evaluation by Using Fibrosis Panel