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

Sichuan University

Status: Enrolling

Conditions: Primary Sclerosing Cholangitis; Autoimmune Hepatitis; Choledochal Cyst; Cirrhosis; HCV; HBV; Biliary Atresia

Treatments: Other: Prediction model

Study type: Observational

Funder types: Other

Identifiers

NCT05181332

HX-2021523

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

400 participants in 2 patient groups

Retrospective cohort

Description:

The internal cohort was retrospectively enrolled in West China Hospital, Sichuan University from June 2010 and December 2020. It is a training and internal validation cohort.

Treatment:

Other: Prediction model

Prospective cohort

Description:

The same inclusion/exclusion criteria were applied for the same center prospectively. It is a external validation cohort.

Treatment:

Other: Prediction model