Preoperative Serum FGF19 in the Prognosis of Biliary Atresia
1 other identifier
observational
200
1 country
1
Brief Summary
To investigate the role of preoperative serum FGF19 level in the prognosis of biliary atresia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2023
CompletedFirst Posted
Study publicly available on registry
May 8, 2023
CompletedStudy Start
First participant enrolled
October 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
March 27, 2026
March 1, 2026
2.6 years
April 28, 2023
March 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Serum total bilirubin level (umol/l)
The difference of serum total bilirubin level will be measured with ELISA( Enzyme Linked ImmunoSorbent Assay) three months after surgery
Three months after surgery
Native liver survival (%)
The difference of native liver survival will be measured according to the follow-up statue one year after surgery
One year after surgery
Study Arms (1)
Good prognosis + Poor prognosis
Good prognosis: the serum total bilirubin level was less than 20 umol/l three months after surgery, and no liver transplantation or death occurred within a year after surgery. Poor prognosis: the serum total bilirubin level was higher than 20 umol/l three months after surgery, and no liver transplantation or death occurred within a year after surgery.
Eligibility Criteria
The study enrolled patients meeting following conditions. * Patients diagnosed as biliary atresia in Children's Hospital of Fudan University * Patients with at least one-year follow-up records after surgery * Patients with a record of serum total bilirubin levels three months after surgery * Patients with preoperative serum left（volume \> 500ul)
You may qualify if:
- Samples diagnosed as biliary atresia in Children's Hospital of Fudan University
- Samples with one-year follow-up records after surgery
- Samples with a record of serum total bilirubin levels three months after surgery
- Samples with preoperative serum left（volume \> 500ul)
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201100, China
Biospecimen
Preoperative serum of biliary atresia patients
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2023
First Posted
May 8, 2023
Study Start
October 15, 2023
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
August 1, 2027
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share