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

NCT ID: NCT03977857

Last Updated: 2021-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

486 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-01

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute-on-Chronic Liver Failure Hepatitis B, Chronic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

28-day nonsurvival or transplantation

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

No interventions assigned to this group

28-day transplantation-free survival

patients who survived without liver transplantation at 28 days since admission

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

He Yingli

Research Associate

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

First Affiliated Hospital Xi'an Jiaotong University

Xi'an, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35029044 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

XJTU1AF2019LSK-2019-061

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Methods to Detect Liver Fibrosis
NCT03027700 TERMINATED NA
MRI in Portal Hypertension
NCT01756859 UNKNOWN