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RecruitingNCT05848310Updated Mar 27, 2026

Preoperative Serum FGF19 in the Prognosis of Biliary Atresia

An observational study in Biliary Atresia and Prognosis, sponsored by Children's Hospital of Fudan University. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by Children's Hospital of Fudan University · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Oct 2023; still recruiting 2 years 11 months later.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
200
Sex
All
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Study summary

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

Read the 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.

02

Conditions studied

  • Biliary Atresia
  • Prognosis

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Keywords

  • Biliary Atresia
  • FGF19
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In context

Biliary Atresia

75 studies on the registry are indexed under Biliary Atresia; 25 are open to participants now.

This study's planned enrollment of 200 is above the median of 126 across 31 observational studies indexed under Biliary Atresia.

Browse Biliary Atresia studies →

Lead sponsor

Children's Hospital of Fudan University is the lead sponsor of 262 studies on the registry; 92 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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)

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

Exclusion Criteria:

  • None
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: Three months after surgery

  2. Native liver survival (%)

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

    Time frame: One year after surgery

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Study locations

1 of 1 sites recruiting
  • Children's Hospital of Fudan University
    Shanghai, Shanghai Municipality 201100, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05848310
Lead sponsor
Children's Hospital of Fudan University
Responsible party
Sponsor
First posted
May 8, 2023
Start date
Oct 15, 2023
Primary completion
Jun 2026 (estimated)
Completion
Aug 2027 (estimated)
Last update
Mar 27, 2026

Study contacts

Shan Zheng
Contact
szheng@shmu.edu.cn
+86 021 64932791
Jiajie Zhu
Contact
jiajiez98@163.com
+86 021 18268899251

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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