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

Hepatitis B, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03977857
• Other study ID #: XJTU1AF2019LSK-2019-061
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2021
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 486
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute-on-Chronic Liver Failure
• End Stage Liver Disease
• Hepatic Insufficiency
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Liver Failure

Locations

Country	Name	City	State
China	First Affiliated Hospital Xi'an Jiaotong University	Xi'an

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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