Preoperative Serum FGF19 in the Prognosis of Biliary Atresia

Prognosis Clinical Trial

Official title:

Preoperative Serum FGF19 in the Prognosis of Biliary Atresia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05848310
• Other study ID #: SFPBA
• Status: Recruiting
• Start date: October 15, 2023
• Est. completion date: August 2024

Study information

• Verified date: February 2024
• Source: Children's Hospital of Fudan University
• Contact: Shan Zheng
• Phone: +86 021 64932791
• Email: szheng[@]shmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Atresia
• Prognosis

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Three months after surgery
Primary	Native liver survival (%)	The difference of native liver survival will be measured according to the follow-up statue one year after surgery	One year after surgery