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临床试验/NCT04975477
NCT04975477Unknown不适用

CHESS-SAVE Score to Stratify Decompensation Risk in Compensated Advanced Chronic Liver Disease: an International Multicenter Study (CHESS2102)

Hepatopancreatobiliary Surgery Institute of Gansu Province7 个研究点 分布在 5 个国家目标入组 1,000 人开始时间: 2021年7月16日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,000
试验地点
7
主要终点
Accuracy of the CHESS-SAVE score for predicting liver decompensation

研究概览

简要总结

Compensated advanced chronic liver disease (cACLD) was associated with a high rate of variceal bleeding, ascites, and hepatic encephalopathy due to portal hypertension. In these patients, esophagogastroduodenoscopy and hepatic venous pressure gradient were recommended methods to evaluate portal hypertension. However, non-invasive predictors of outcomes to stratify care remains needed. Although the updated EASL guideline has recommended that patients with liver stiffness >20kPa or platelets <150*10^9/L had the high risk of decompensation, the criteria remains to be validated. This international multicenter study aims to develop a novel CHESS-SAVE score to further predict the risk of liver decompensation in cACLD patients.

详细描述

Compensated advanced chronic liver disease (cACLD) was associated with a high rate of variceal bleeding, ascites, and hepatic encephalopathy due to portal hypertension. In these patients, esophagogastroduodenoscopy and hepatic venous pressure gradient were recommended methods to evaluate portal hypertension. However, non-invasive predictors of outcomes to stratify care remains needed. Although the updated EASL guideline has recommended that patients with liver stiffness >20kPa or platelets <150*10^9/L had the high risk of decompensation, the criteria remains to be validated. This international multicenter study initialed and enrolled by Chinese Portal Hypertension Alliance (CHESS) aims to develop a novel CHESS-SAVE score to further predict the risk of liver decompensation in cACLD patients.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age more than 18 years;
  • fulfilled diagnosis of cACLD based on radiological, histological features of liver cirrhosis

排除标准

  • prior liver decompensation;
  • hepatocellular carcinoma;
  • prior liver transplantation;
  • portal vein thrombosis;
  • antiplatelet or anticoagulation;
  • without screening EGD within six months of TE;
  • incomplete follow-up data.
  • HVPG cohort
  • Inclusion Criteria:
  • age more than 18 years;
  • fulfilled diagnosis of cACLD based on radiological, histological features of liver cirrhosis
  • Exclusion Criteria:
  • prior liver decompensation;
  • hepatocellular carcinoma;
  • prior liver transplantation;
  • portal vein thrombosis;
  • antiplatelet or anticoagulation;
  • without screening EGD within six months of TE;
  • without HVPG measurement;
  • non-sinusoidal portal hypertension.

结局指标

主要结局

Accuracy of the CHESS-SAVE score for predicting liver decompensation

时间窗: 3 years

To assess the accuracy of the CHESS-SAVE score to predict liver decompensation in patients with compensated advanced chronic liver disease

次要结局

未报告次要终点

研究者

发起方
Hepatopancreatobiliary Surgery Institute of Gansu Province
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaolong Qi

Chief

Hepatopancreatobiliary Surgery Institute of Gansu Province

研究点 (7)

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