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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 2 months
Maximum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
RECRUITING
Shanghai
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
NOT_YET_RECRUITING
Shanghai
Contact Information
Primary
Yi ZHOU
fenghao@renji.com
008619921528834
Time Frame
Start Date: 2022-04-30
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 1200
Treatments
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.
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.
Sponsors
Leads: RenJi Hospital

This content was sourced from clinicaltrials.gov