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Preoperative Serum FGF19 in the Prognosis of Biliary Atresia

Preoperative Serum FGF19 in the Prognosis of Biliary Atresia

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05848310
Enrollment
200
Registered
2023-05-08
Start date
2023-10-15
Completion date
2027-08-01
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Atresia, Prognosis

Keywords

Biliary Atresia, FGF19

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.

Interventions

None listed

Sponsors

Children's Hospital of Fudan University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
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

* None

Design outcomes

Primary

MeasureTime frameDescription
Serum total bilirubin level (umol/l)Three months after surgeryThe difference of serum total bilirubin level will be measured with ELISA( Enzyme Linked ImmunoSorbent Assay) three months after surgery
Native liver survival (%)One year after surgeryThe difference of native liver survival will be measured according to the follow-up statue one year after surgery

Countries

China

Contacts

CONTACTShan Zheng
szheng@shmu.edu.cn+86 021 64932791
CONTACTJiajie Zhu
jiajiez98@163.com+86 021 18268899251

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026