Prediction Model Based on Computed Tomography Liver Volume for the Short-term Mortality in Hepatitis B Related Acute-on-Chronic

NCT03977857 | Completed

• 1 other identifier: XJTU1AF2019LSK-2019-061
• Study Type: observational
• Target: 486
• Locations: 1 country
• Sites: 1

Brief Summary

HBV-related acute-on-chronic liver failure (HBV-ACLF) deteriorates rapidly with a high short-term mortality. Early identification and accurate prognostic prediction was critical to improve survival rate. This study was sought to determine the liver volumetry as predictor for short-term mortality in HBV-ACLF and develop a simpler prognostic model based on liver morphology. Liver volumetry were determined from CT at admission. Univariate and multivariate logistic regression were used to identify the optimum prognostic indicators and develop prognostic model. Additionally, receiver operating characteristic curves were analyzed to evaluate the predictive ability of the model.

Conditions

Acute-on-Chronic Liver Failure; Hepatitis B, Chronic

Keywords

Hepatitis B; Acute-on-Chronic liver failure; liver volume; prognostic model

Outcome Measures

Primary Outcomes (1)

• Overall survival of ACLF subjects

  Overall survival in subjects with hepatitis B virus-related acute-on-chronic liver failure will be summarized and compared with control subjects through study day 28.

  28 days

Study Arms (2)

28-day nonsurvival or transplantation

patients who died or underwent liver transplantation within 28 days since admission

28-day transplantation-free survival

patients who survived without liver transplantation at 28 days since admission

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All the patients were diagnosed with hepatitis B virus-related acute-on-chronic liver failure who met with the inclusion criteria and exclusion criteria. Two cohorts of subjects were enrolled in several liver centers. In the modeling cohort, subjects were identified retrospectively from patients with acute exacerbation of chronic hepatitis B manifesting as hepatic encephalopathy (HE), upper gastrointestinal bleeding, ascites, acute jaundice and coagulopathy, referred from January 1, 2015 to December 31,2019. In the validation cohort, subjects were enrolled from external liver centers for validating the model.

You may qualify if:

• age 18-70 years, male or female.
• Acute hepatic insult manifesting as jaundice and coagulopathy, complicated within 4 weeks by ascites, and/or encephalopathy in a patient with chronic HBV infection
• Abdominal CT examination was performed within 3 days after admission
• Biochemical examinations were available within 3 days before or after CT scan

You may not qualify if:

• Patients with evidence of non-B hepatitis virus: alcohol abuse leads to liver failure, autoimmune leads to liver failure, oxic or other causes that might lead to liver failure
• Past or current hepatocellular carcinoma
• Serious diseases in other organ systems
• Chronic liver failure
• There was no CT imaging data or the interval between CT scan and diagnosis of liver failure \>3 days

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital Xi'an Jiaotong University

Xi'an, China

Location

Related Publications (1)

• Hu C, Jiang N, Zheng J, Li C, Huang H, Li J, Li H, Gao Z, Yang N, Xi Q, Wang J, Liu Z, Rao K, Zhou H, Li T, Chen Y, Zhang Y, Yang J, Zhao Y, He Y. Liver volume based prediction model for patients with hepatitis B virus-related acute-on-chronic liver failure. J Hepatobiliary Pancreat Sci. 2022 Dec;29(12):1253-1263. doi: 10.1002/jhbp.1112. Epub 2022 Jan 25.

  PMID: 35029044 DERIVED

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure; Hepatitis B, Chronic; Hepatitis B

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 6, 2019
• Study Start: March 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 25, 2021

Record last verified: 2021-02

Locations

CN (1)