Biliary AtresiaNCT05848310
Preoperative Serum FGF19 in the Prognosis of Biliary Atresia
An observational study of Biliary Atresia and Prognosis, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
To investigate the role of preoperative serum FGF19 level in the prognosis of biliary atresia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Biliary Atresia, Prognosis
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2023to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study enrolled patients meeting following conditions. * Patients diagnosed as biliary atresia in Children's Hospital of Fudan University * Patients with at least one-year follow-up records after surgery * Patients with a record of serum total bilirubin levels three months after surgery * Patients with preoperative serum left（volume > 500ul)
Who may be able to join
- 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)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201100
About this study
To investigate the role of preoperative serum FGF19 level in the prognosis of biliary atresia.
Read the detailed 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.
- Conditions
- Biliary Atresia, Prognosis
- Keywords
- Biliary Atresia, FGF19
- Medical subject headings
- Biliary Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Three months after surgery
Native liver survival (%)
The difference of native liver survival will be measured according to the follow-up statue one year after surgery
Measured: One year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start15 Oct 2023
- Primary completionJun 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary AtresiaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848310
- Sponsor's protocol ID
- SFPBA
- Status last verified
- Mar 2026
- First submitted
- 28 Apr 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Serum FGF19 in the Prognosis of Biliary Atresia
- ClinicalTrials.gov ID
- NCT05848310
- Acronym / sponsor ID
- SFPBA
- Conditions
- Biliary Atresia, Prognosis
- Keywords
- Biliary Atresia, FGF19
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 8 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the role of preoperative serum FGF19 level in the prognosis of biliary atresia.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study enrolled patients meeting following conditions. * Patients diagnosed as biliary atresia in Children's Hospital of Fudan University * Patients with at least one-year follow-up records after surgery * Patients with a record of serum total bilirubin levels three months after surgery * Patients with preoperative serum left（volume > 500ul)
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Atresia and Prognosis, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shan Zheng (+86 021 64932791, szheng@shmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum total bilirubin level (umol/l) (time frame: Three months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.