跳至主要内容
临床试验/NCT05208736
NCT05208736Unknown不适用

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

First Affiliated Hospital Xi'an Jiaotong University2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
试验地点
2
主要终点
Overall survival of subjects with cirrhosis

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • patients with liver cancer and other malignant tumors.
  • Patients accompanied by severe respiratory and circulatory diseases.
  • Patients had a history of previous transplantation.

结局指标

主要结局

Overall survival of subjects with cirrhosis

时间窗: 5 years

Overall survival of patients with liver cirrhosis will be summarized and compared with control subject within 5 years.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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