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Clinical Trials/NCT05848310
NCT05848310RecruitingNot Applicable

Preoperative Serum FGF19 in the Prognosis of Biliary Atresia

Children's Hospital of Fudan University1 site in 1 country200 target enrollmentStarted: October 15, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
200
Locations
1
Primary Endpoint
Serum total bilirubin level (umol/l)

Study Overview

Brief Summary

To investigate the role of preoperative serum FGF19 level in the prognosis of biliary atresia.

Detailed Description

Kasai portoenterostomy is currently one of the main treatment methods for biliary atresia, but about 30% of children still require liver transplantation even after receiving the surgery. Accurate prognosis will help select the most suitable treatment method for children, but there is currently a lack of effective preoperative predictive indicators. Serum FGF19 has recently been considered a possible preoperative predictive indicator for biliary atresia, but its predictive value has not been confirmed in a large sample and in Asian population, thus the investigators try to further explore the prognostic value of serum FGF19 in children with biliary atresia based on a large sample.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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)

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Serum total bilirubin level (umol/l)

Time Frame: Three months after surgery

The difference of serum total bilirubin level will be measured with ELISA( Enzyme Linked ImmunoSorbent Assay) three months after surgery

Native liver survival (%)

Time Frame: One year after surgery

The difference of native liver survival will be measured according to the follow-up statue one year after surgery

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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