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Establishment of a diagnostic model of biliary atresia ultrasound combined with MMP-7: a multicenter diagnostic accuracy study

Establishment of a diagnostic model of biliary atresia ultrasound combined with MMP-7: a multicenter diagnostic accuracy study

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200055459
Enrollment
Unknown
Registered
2022-01-10
Start date
2022-02-01
Completion date
Unknown
Last updated
2023-02-06

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

Conditions

Biliary atresia

Interventions

combined&#32
diagnostic&#32
Gold Standard:Biliary tract exploration and liver pathology.
Index test:MMP-7,&#32
and&#32
ultrasound&#32

Sponsors

Pediatric Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged =17umol/L; or serum total bilirubin >=85umol/L, but direct bilirubin accounts for more than 20% of total bilirubin; 3. Gestational age >= 28 weeks, birth weight >= 1000g; 4. Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. There was a history of severe hypoxia at birth, and the 5-minute Apgar score was less than 5; 2. According to clinical manifestations, laboratory tests, etc., diagnosed with allergic diseases, inflammatory bowel diseases, and infectious diseases; 3. Other serious congenital malformations and immunodeficiencies; 4. It is impossible to complete the sampling before the gold standard diagnosis; 5. Give up further diagnosis and treatment, unable to obtain a definite diagnosis.

Design outcomes

Primary

MeasureTime frame
MMP-7;Ultrasound;sensitivity, specificity, accuracy;

Countries

China

Contacts

Public ContactZheng Shan

Pediatric Hospital Affiliated to Fudan University

szheng@shmu.edu.cn+86 15900898826

Outcome results

None listed

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