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出境医 / 临床实验 / Prediction Model Based on Computed Tomography Liver Volume for the Short-term Mortality in Hepatitis B Related Acute-on-Chronic

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

Study Description
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.

Condition or disease
Acute-on-Chronic Liver Failure Hepatitis B, Chronic

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 Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 486 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prediction Model Based on Computed Tomography Liver Volume for Predicting Short-term Mortality in Hepatitis B-Acute-on-Chronic Liver Failure
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019
Arms 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
Outcome Measures
Primary Outcome Measures :
  1. 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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations

Locations
Layout table for location information
China
First Affiliated Hospital Xi'an Jiaotong University
Xi'an, China
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Tracking Information
First Submitted Date June 5, 2019
First Posted Date June 6, 2019
Last Update Posted Date February 25, 2021
Actual Study Start Date March 1, 2019
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 5, 2019) 		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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prediction Model Based on Computed Tomography Liver Volume for the Short-term Mortality in Hepatitis B Related Acute-on-Chronic
Official Title Prediction Model Based on Computed Tomography Liver Volume for Predicting Short-term Mortality in Hepatitis B-Acute-on-Chronic Liver Failure
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.
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
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Acute-on-Chronic Liver Failure
  • Hepatitis B, Chronic
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 23, 2021) 		486
Original Estimated Enrollment
 (submitted: June 5, 2019) 		150
Actual Study Completion Date December 31, 2019
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03977857
Other Study ID Numbers XJTU1AF2019LSK-2019-061
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party He Yingli, First Affiliated Hospital Xi'an Jiaotong University
Study Sponsor First Affiliated Hospital Xi'an Jiaotong University
Collaborators Not Provided
Investigators Not Provided
PRS Account First Affiliated Hospital Xi'an Jiaotong University
Verification Date February 2021

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