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Multicenter study of non-invasive diagnostic scoring system for biliary atresia

Multicenter study of non-invasive diagnostic scoring system for biliary atresia

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100044533
Enrollment
Unknown
Registered
2021-03-23
Start date
2021-06-01
Completion date
Unknown
Last updated
2021-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary atresia

Interventions

Gold Standard:Intraoperative cholangiography
diagnostic&#32
system&#32
for&#32
atresia&#32
(Biochemicaltests,&#32
blood&#32
ammonia,&#32
AFP,&#32
hepatobiliary&#32
ultrasound)

Sponsors

Children's Hospital Affiliated to Zhejiang University Medical College
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Clinical features: a. Skin jaundice, b. Fecal whitening (yellowish, white), c. The color of urine becomes darker, d. Enlarged liver, hardened liver. 2) Blood biochemical characteristics: conjugated bilirubin > 2.0 mg/dL (or 34umol/L), or direct bilirubin / total bilirubin >= 20%. 3) the age is less than 4 months, and the duration of jaundice is longer than the first 2 weeks after birth. 4) the patient's legal representative has signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1) TPN-related cholestasis. 2) diseases associated with other major structural malformations. 3) there are known or suspected neuroendocrine or metabolic diseases. 4) past history combined with life-threatening diseases of various organ systems. 5) patients who have participated in other clinical trials in the last 3 months. 6) any other circumstances in which the researchers do not consider it appropriate to participate in the trial.

Design outcomes

Primary

MeasureTime frame
Biochemicaltests;hepatobiliary B ultrasound;SEN, SPE, ACC, AUC of ROC;

Secondary

MeasureTime frame
blood routine;CRP;blood ammonia;AFP;

Countries

China

Contacts

Public ContactJinfa Tou

The Children's Hospital of Zhejiang University School of Medicine

toujinfa@zju.edu.cn+86 13600510819

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026