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Establishment of an early accurate and non-invasive diagnostic model for biliary atresia

Establishment of an early accurate and non-invasive diagnostic model for biliary atresia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200064745
Enrollment
Unknown
Registered
2022-10-15
Start date
2022-10-15
Completion date
Unknown
Last updated
2023-05-15

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:Biliary tract exploration
Index test:serum MMP-7, ultrasound of liver and bile duct and gallbladder,combined diagnostic model based on serum MMP-7,diagnostic accuracy, diagnostic sensitivity, diagnostic specificity, positive p

Sponsors

Chengdu Women's and Children's Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age:=17umol/L; Alternatively, serum total bilirubin>=85umol/L, but direct bilirubin accounts for more than 20% of total bilirubin; 3. Pregnancy>=28 weeks, birth weight>=1000g; 4. Sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. It is impossible to complete the sampling before the gold standard diagnosis; 2. Give up further diagnosis and treatment, unable to obtain a definite diagnosis.

Design outcomes

Primary

MeasureTime frame
serum MMP-7;ultrasound of liver and bile duct and gallbladder;combined diagnostic model based on serum MMP-7;diagnosis sensitivity;diagnosis specificity;Accuracy of diagnosis;Positive predictive value;Negative predictive value;

Countries

China

Contacts

Public ContactMin Du

Chengdu Women's and Children's Central Hospital,

40957664@qq.com+86 15198025686

Outcome results

None listed

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