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Preoperative Serum FGF19 in the Prognosis of Biliary Atresia

NCT ID: NCT05848310

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-15

Study Completion Date

2027-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Biliary Atresia Prognosis

Keywords

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Biliary Atresia FGF19

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Good prognosis + Poor prognosis

Good prognosis: the serum total bilirubin level was less than 20 umol/l three months after surgery, and no liver transplantation or death occurred within a year after surgery.

Poor prognosis: the serum total bilirubin level was higher than 20 umol/l three months after surgery, and no liver transplantation or death occurred within a year after surgery.

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shan Zheng

Role: CONTACT

Phone: +86 021 64932791

Email: [email protected]

Jiajie Zhu

Role: CONTACT

Phone: +86 021 18268899251

Email: [email protected]

Other Identifiers

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SFPBA

Identifier Type: -

Identifier Source: org_study_id