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

NCT05181332 | Unknown

• 1 other identifier: HX-2021523
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Hepatic decompensation

  The 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)

  At least 5-year follow up

Secondary Outcomes (1)

• Overall survival

  At least 5-year follow up

Study Arms (2)

Retrospective cohort

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.

Other: Prediction model

Prospective cohort

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

Other: Prediction model

Interventions

Prediction model OTHER

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

Prospective cohort; Retrospective cohort

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients with cirrhosis who were diagnosed histologically with definite pathologic specimens.

You may qualify if:

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

You may not qualify if:

• Clinical data missing
• Without written informed consent

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 6100000, China

RECRUITING

MeSH Terms

Conditions

Fibrosis; Biliary Atresia; Choledochal Cyst; Cholangitis, Sclerosing; Hepatitis, Autoimmune

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cysts; Neoplasms; Cholangitis; Hepatitis, Chronic; Hepatitis; Liver Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Yuhan Yang, MD

CONTACT

8613258389785; yyh_1023@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 6, 2022
• Study Start: January 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 20, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)