Investigating serum FGF19 levels for predicting outcomes in biliary atresia
Preoperative Serum FGF19 in the Prognosis of Biliary Atresia
Children's Hospital of Fudan University · NCT05848310
This study is testing if measuring a specific protein in the blood can help doctors predict how well children with biliary atresia will do after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | Children's Hospital of Fudan University (other) |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05848310 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the prognostic value of preoperative serum FGF19 levels in children diagnosed with biliary atresia. The research focuses on children who have undergone Kasai portoenterostomy, a common treatment for this condition, to determine if FGF19 can serve as an effective predictive indicator for post-surgical outcomes. By analyzing a large sample from the Children's Hospital of Fudan University, the study seeks to fill the gap in preoperative predictive indicators that can guide treatment decisions. The findings could potentially lead to improved management strategies for affected children.
Who should consider this trial
Good fit: Ideal candidates for this study are children diagnosed with biliary atresia who have undergone surgery and have follow-up records available.
Not a fit: Patients who do not have a diagnosis of biliary atresia or lack the necessary follow-up records will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable preoperative indicator to better predict outcomes for children with biliary atresia, potentially reducing the need for liver transplantation.
How similar studies have performed: While the role of serum FGF19 in biliary atresia has been considered, this study aims to confirm its predictive value in a large Asian population, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai Municipality
- Children's Hospital of Fudan University — Shanghai, Shanghai Municipality, China (RECRUITING)
Study contacts
- Study coordinator: Shan Zheng
- Email: szheng@shmu.edu.cn
- Phone: +86 021 64932791
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Biliary Atresia, Prognosis, FGF19