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Recruiting NCT05848310

Preoperative Serum FGF19 in the Prognosis of Biliary Atresia

Observational Biliary Atresia Prognosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Biliary Atresia, Prognosis. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Serum total bilirubin level (umol/l) [Time frame: Three months after surgery]
  • Native liver survival (%) [Time frame: One year after surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

China · 1 center
  • Children's Hospital of Fudan University — Shanghai

Identifiers

NCT: NCT05848310 · SFPBA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗