A Model Based on Computed Tomography Imaging Parameters to Predict Poor Survival in Patients With Liver Cirrhosis

NCT ID: NCT05208736

Last Updated: 2022-04-18

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

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-03-15

Brief Summary

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Cirrhosis, as the end stage of most chronic liver diseases, is an important clinical landmark portending high risk of death. Early identification and accurate prognostic scores is critical issue to improve survival rate. Loss of muscle mass and other body features, which can be determined from CT, have been associated with mortality in cirrhosis or hepatic carcinoma. In this study, we sought to investigate serial changes of CT imaging parameters, such as the skeletal muscle index (SMI), liver volume, adiposity density and so forth, to develop a new prognostic model for long-term motality in patients with liver cirrhosis. The final predictive model was developed under the Cox regression framework with MELD, Child-Pugh score, baseline and serial changes of CT imaging parameters. The discrimination of the new risk score was assessed by the overall C index.

Detailed Description

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Cirrosis, which is always manifesting as ascites, hepatic encephalopathy, upper gastrointestinal bleeding, severe jaundice and coagulopathy, deteriorates rapidly with a high mortality. Early identification and accurate predicted model may be the key to make duly clinical decision and improve prognosis.

When hepatic disorders accur, cirrhosis is often accompanied by varying degrees of malnutrition, which is accurately reflexed by the cross-sectioned areas of the muscles at the third lumbar vertebra level normalized by the square of the height (L3-SMI). In addition, previous studies have shown that lower density of adiposity and altered liver volume were often associated with adverse clinical events.

These changes in body composition can be accurately assessed and measured by using CT scans. However, there is no ideas whether these imaging patameters are reliable indicators to predict the mortality of cirrhosis. In this study, we aimed to evaluate the difference of serial changes of L3-SMI, the density of adiposity and liver volume between 5-year survival and non-survival group and develop a new prognostic model based on these CT imaging data. This study highlighted the clinical significance of serial changes of CT imaging data in predicting the long-term outcome of patients with cirrhosis for the first time.

Conditions

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Liver Cirrhosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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5-year nonsurvival or transplantation

Patients who died or underwent liver transplantation within 5 years since admission.

No interventions assigned to this group

5-year transplantation-free survival

Patients who survival without liver transplantation at 5 years since admission.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Age 18-75 years
2. The diagnosis of liver cirrhosis based on imaging, laboratory and/or histological patameters from a board-certified hepatologist.
3. Patients who underwent at least two abdominal CT examinations, and the interval between the first and the second check was more than one year.
4. CT examination included the cross-sectional areas of muscle at L3 level.
5. Basic patient data included age, gender, weight, height, biochemical examination, complications and 5-year survival.
6. Biochemical examinations were available within 7 days before or after CT scan.

Exclusion Criteria

1. patients with liver cancer and other malignant tumors.
2. Patients accompanied by severe respiratory and circulatory diseases.
3. Patients had a history of previous transplantation.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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First Affiliated Hospital Xi'an Jiaotong University

Xi'an, Shannxi, China

Site Status RECRUITING

First Affiliated Hospital, Xi'an Jiaotong University

Xi'an, Shannxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fulian Zhao

Role: CONTACT

15109509175

Yingli He

Role: CONTACT

18991232863

Facility Contacts

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Fulian Zhao

Role: primary

15109509175

Yingli He

Role: backup

18991232863

Fulian Zhao

Role: primary

15109509175

Yingli He

Role: backup

18991232863

Other Identifiers

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XJTU1AF2019LSL-026

Identifier Type: -

Identifier Source: org_study_id

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