Pediatric Liver Transplantation-Liver Fibrosis Evaluation by Using Fibrosis Panel

NCT05308628 | Recruiting

• 1 other identifier: Renji-IIT-2022-0002
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Liver Fibrosis; Pediatric Disorder; Liver Transplant; Complications

Outcome Measures

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

  12 months post-transplant

Secondary Outcomes (1)

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

  6 months post-transplant

Study Arms (2)

Post-Transplant-Liver Allograft Fibrosis

ACTIVE COMPARATOR

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.)

Post-Transplant-Liver Allograft regular recovery

SHAM COMPARATOR

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.)

Interventions

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.)

Also known as: Liver Allograft Fibrosis by Using Fibrosis Panel(FBLN3,YKL40,LECT2 etc.)

Post-Transplant-Liver Allograft Fibrosis; Post-Transplant-Liver Allograft regular recovery

Eligibility Criteria

• Age: 2 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (2)

Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, 200127, China

RECRUITING

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, 200127, China

NOT YET RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hao FENG

  Dept. of Liver surgery, Renji Hospital, Medical School of Shanghai Jiaotong University

  STUDY DIRECTOR

Central Study Contacts

Yi ZHOU

CONTACT

008619921528834; fenghao@renji.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: April 4, 2022
• Study Start: April 30, 2022
• Primary Completion: August 31, 2024
• Study Completion: November 30, 2025
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

CN (2)