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

February 23, 2021 updated by: He Yingli, First Affiliated Hospital Xi'an Jiaotong University

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

HBV-ACLF deteriorates rapidly with a high short-term mortality and early identification and accurate prognostic prediction may be the key to make clinical decision and improve survival rate. Liver volume, non-invasively reflects the balance of structural collapse with hepatic regeneration, predicting the prognosis of liver diseases. However, there is no idea whether the liver volume is an indicator to predict the mortality of HBV-ACLF patients. The present study evaluated the difference of liver volume between 28-day survival group and non-survivals and developed a new prognostic model based on liver volume . This study highlighted the significance of liver morphology in predicting the outcome of HBV-ACLF for the first time.

Study Type

Observational

Enrollment (Actual)

486

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Xi'an, China
        • First Affiliated Hospital Xi'an Jiaotong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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
  2. Past or current hepatocellular carcinoma
  3. Serious diseases in other organ systems
  4. Chronic liver failure
  5. There was no CT imaging data or the interval between CT scan and diagnosis of liver failure >3 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival of ACLF subjects
Time Frame: 28 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

June 5, 2019

First Submitted That Met QC Criteria

June 5, 2019

First Posted (Actual)

June 6, 2019

Study Record Updates

Last Update Posted (Actual)

February 25, 2021

Last Update Submitted That Met QC Criteria

February 23, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF2019LSK-2019-061

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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