Evaluating liver fibrosis in children after liver transplantation
Effect of the Fibrosis Panel on the Evaluation of Allograft Fibrosis After Pediatric Liver Transplantation
This study is testing a new way to check for liver scarring in children who have had a liver transplant to see how their liver is doing after the surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1200 (estimated) |
| Ages | 2 Months to 18 Years |
| Sex | All |
| Sponsor | RenJi Hospital Academic / other |
| Locations | 2 sites (Shanghai and 1 other locations) |
| Trial ID | NCT05308628 on ClinicalTrials.gov |
What this trial studies
This study investigates the role of a Fibrosis Panel in assessing liver fibrosis in pediatric patients who have undergone liver transplantation. It involves a cross-sectional analysis of children aged 8 weeks to 18 years who received their first liver allograft between 2016 and 2021. Participants will undergo liver biopsies at 3, 6, and 12 months post-transplant, with fibrosis evaluated using established scoring systems. Blood samples will also be collected for biochemical tests and future research.
Who should consider this trial
Good fit: Ideal candidates are children aged 8 weeks to 18 years who have received a first liver transplant from either cadaveric or living donors.
Not a fit: Patients older than 18 years, those with active systemic infections, or those undergoing multi-organ transplantation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the long-term liver health of children post-transplant, potentially improving monitoring and treatment strategies.
How similar studies have performed: Other studies have shown success in using fibrosis markers in adult populations, but this specific approach in pediatric liver transplantation is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Shanghai and 1 other locations
- Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai, China (Recruiting)
- Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai, China (Not_yet_recruiting)
Study contacts
- Study coordinator: Yi ZHOU
- Email: fenghao@renji.com
- Phone: 008619921528834
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.