Pediatric Liver Transplantation-Liver Fibrosis Evaluation by Using Fibrosis Panel (PT-LiFE)

August 5, 2024 updated by: RenJi Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The cross-section study will be performed in pediatric patients who underwent liver transplantation from year 2016-2021. Patients will be enrolled after collecting their informed consent from their parents. As soon as the patient is included, arrangements will be made for the liver biopsy according to the schedule.

Liver biopsies will be performed at 3 months, 6 months and 12 months post-transplant. For the purpose of this study, each section was independently and blindly reassessed by expert pathologists. Fibrosis was evaluated using the liver allograft fibrosis score (LAFSc) staging system [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).

At the time of biopsy, a fasting blood sample was obtained and routine biochemical tests were performed using standard methods and assays. Additional blood samples were drawn and frozen at -80℃ for future research. Type III collagen formation was assessed in serum using the Fibrosis Panel(PRO-C3, PIIINP, TIMP-1, HA) competitive enzyme-linked immunosorbent assay.

Study Type

Interventional

Enrollment (Estimated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200127
        • Recruiting
        • Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
        • Contact:
      • Shanghai, China, 200127
        • Not yet recruiting
        • Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Post-Transplant-Liver Allograft Fibrosis
Pediatric patients who have undergone liver transplantation , the occurrence of graft fibrosis necessitates hospitalization for biopsy and treatment to assess the degree of fibrosis and its underlying causes.
Diagnostic test: Liver 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.)
Other Names:
  • Liver Allograft Fibrosis by Using Fibrosis Panel(FBLN3,YKL40,LECT2 etc.)
Sham Comparator: Post-Transplant-Liver Allograft regular recovery
Pediatric patients who have undergone liver transplantation and have recovered normally typically undergo liver biopsy around 3 to 5 years postoperatively and around 10 years postoperatively to evaluate the presence of potential subclinical rejection. This assessment guides the long-term application of immunosuppressive medications.
Diagnostic test: Liver 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.)
Other Names:
  • Liver Allograft Fibrosis by Using Fibrosis Panel(FBLN3,YKL40,LECT2 etc.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
liver allograft fibrosis score (LAFSc) staging system(12 months)
Time Frame: 12 months post-transplant
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
12 months post-transplant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
liver allograft fibrosis score (LAFSc) staging system(6 months)
Time Frame: 6 months post-transplant
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
6 months post-transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Investigators

  • Study Director: Hao FENG, Dept. of Liver surgery, Renji Hospital, Medical School of Shanghai Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2022

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

January 17, 2022

First Submitted That Met QC Criteria

April 1, 2022

First Posted (Actual)

April 4, 2022

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 5, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Renji-IIT-2022-0002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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