Preoperative Serum FGF19 in the Prognos… | Clinical Trial

Key information

Conditions

Biliary Atresia Bile Duct Diseases Biliary Tract Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases Prognosis

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201100, China

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Serum total bilirubin level (umol/l)

Time frame: Three months after surgery

The difference of serum total bilirubin level will be measured with ELISA( Enzyme Linked ImmunoSorbent Assay) three months after surgery
Native liver survival (%)

Time frame: One year after surgery

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jiajie Zhu

CONTACT

[email protected]

+86 021 18268899251

Shan Zheng

CONTACT

[email protected]

+86 021 64932791

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2027
First posted: May 8, 2023
Registry last updated: Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting