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Predictive Models of Hepatic Decompensation and Survival Outcomes in Pediatric Patients With Cirrhosis

Predictive Models of Hepatic Decompensation and Survival Outcomes in Pediatric Patients With Cirrhosis

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05181332
Enrollment
400
Registered
2022-01-06
Start date
2021-01-01
Completion date
2024-12-31
Last updated
2022-01-20

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

Conditions

Autoimmune Hepatitis, Biliary Atresia, Choledochal Cyst, Cirrhosis, HBV, HCV, Primary Sclerosing Cholangitis

Brief summary

The aim of this study was to developed and validated models to predict hepatic decompensation and survivals in pediatric patients with cirrhosis and compared these models with currently available models.

Detailed description

Noninvasive liver fibrosis tests such as the NAFLD fibrosis score (NFS), Hepascore, and transient elastography were specifically developed to predict fibrosis and can help predict patients with NAFLD at the highest risk of developing liver-related complications. These tests have been widely applied in adult cirrhosis. The accuracy of these models, however, may be influenced by patient factors including age, body mass index, and diabetes, potentially limiting their prognostic accuracy and clinical practicability in children. Therefore, it is currently unknown how to best predict hepatic decompensation and survival outcomes among pediatric patients with cirrhosis. To fill this knowledge gap, the investigators performed a retrospective-prospective cohort study with the aim of developing and validating a clinical model to predict liver-related complications and survival outcomes in pediatric patients with biopsy-proven with cirrhosis. Secondly, the investigators aimed to compare the predictive accuracy with currently available noninvasive model.

Interventions

OTHERPrediction model

Clinical models were developed and validated to predict liver-related complications and survival outcomes in pediatric patients with biopsy-proven with cirrhosis.

Sponsors

West China Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
0 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* Age up to 18 years old * No previous episodes of clinical decompensation * With written informed consent

Exclusion criteria

* Clinical data missing * Without written informed consent

Design outcomes

Primary

MeasureTime frameDescription
Hepatic decompensationAt least 5-year follow upThe primary outcome was the first event of hepatic decompensation, defined by the occurrence of any of the following: ascites (identified or confirmed by abdominal ultrasound), upper gastrointestinal bleeding secondary to portal hypertension (confirmed by endoscopy in the presence of gastroesophageal varices or portal hypertensive gastropathy), or hepatic encephalopathy (established by clinical parameters, neuropsychological tests, or electroencephalogram)

Secondary

MeasureTime frameDescription
Overall survivalAt least 5-year follow upThe endpoint was defined as the occurrence of death or the last follow-up. Patients were followed from the day of liver biopsy until the occurrence of death, liver transplant, or last visit. The outcome was evaluated by an experienced hepatologist in each center every 3-6 months. At each visit, a medical history, physical examination, and standard laboratory tests were performed.

Countries

China

Contacts

Primary ContactYuhan Yang, MD
yyh_1023@163.com8613258389785

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026