Actively Recruiting

All Genders
ID05848310

Preoperative Serum FGF19 in the Prognosis of Biliary Atresia

Led by Children's Hospital of Fudan University · Updated on 2026-03-27

200

Participants Needed

1

Research Sites

60 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are exploring how preoperative levels of serum FGF19 might predict outcomes for children with biliary atresia, a serious liver condition. The study focuses on children who have undergone Kasai portoenterostomy, a common surgery for this condition. Since about 30% of these children may still need a liver transplant after surgery, finding accurate ways to predict prognosis before surgery is important. This research aims to confirm the value of serum FGF19 as a predictive marker in a large group of Asian children. The study observes children diagnosed with biliary atresia who have had the Kasai surgery. It classifies their prognosis into two groups based on serum total bilirubin levels measured three months after surgery and liver transplant or survival status at one year. A good prognosis means bilirubin is less than 20 umol/l and no transplant or death within a year; a poor prognosis means bilirubin is higher than 20 umol/l without transplant or death in that time. Researchers collect and analyze preoperative serum samples and follow patients for one year. Participants will have their clinical data and serum bilirubin levels recorded three months after surgery, followed by monitoring their liver survival status for one year. The study measures serum total bilirubin levels and native liver survival as primary outcomes. Data collection involves reviewing preoperative serum samples and follow-up records. Children with biliary atresia and available surgical and follow-up data will be included, with no specific age restrictions. The study is conducted by the Children's Hospital of Fudan University and will continue until August 2027.

CONDITIONS

Brief Title

Preoperative Serum FGF19 in the Prognosis of Biliary Atresia

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with biliary atresia at Children's Hospital of Fudan University
  • Have follow-up records for at least one year after surgery
  • Have recorded serum total bilirubin levels measured three months after surgery
  • Have preoperative serum samples with a volume greater than 500 microliters
Not Eligible

You will not qualify if you...

  • None

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery

Duration - Day of surgery

Participants undergo Kasai portoenterostomy surgery for biliary atresia.

1 visit (in-person)

Post-operative Follow-up

Duration - One year after surgery

Participants are monitored through follow-up visits to assess serum total bilirubin levels and native liver survival.

Follow-up visits including assessment at 3 months and periodic monitoring up to 1 year

Trial Site Locations

Total: 1 location

1

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China, 201100

Actively Recruiting

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Research Team

S

Shan Zheng

J

Jiajie Zhu

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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