CHESS-SAVE Score to Stratify Decompensation Risk in Compensated Advanced Chronic Liver Disease (CHESS2102)
- Conditions
- Compensated Advanced Chronic Liver Disease
- Interventions
- Procedure: Esophagogasrtoduodendoscopy and liver stiffnessProcedure: hepatic venous pressure gradient
- Registration Number
- NCT04975477
- Lead Sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu Province
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
- age more than 18 years;
- fulfilled diagnosis of cACLD based on radiological, histological features of liver cirrhosis
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Training cohort Esophagogasrtoduodendoscopy and liver stiffness A cohort was used to develop the novel score for predicting liver decompensation Validation cohort Esophagogasrtoduodendoscopy and liver stiffness A cohort was used to validate the performance of novel score for predicting liver decompensation Exploratory cohort hepatic venous pressure gradient A cohort was used to study the diagnostic value of novel score for clinically significant portal hypertension Exploratory cohort Esophagogasrtoduodendoscopy and liver stiffness A cohort was used to study the diagnostic value of novel score for clinically significant portal hypertension
- Primary Outcome Measures
Name Time Method Accuracy of the CHESS-SAVE score for predicting liver decompensation 3 years To assess the accuracy of the CHESS-SAVE score to predict liver decompensation in patients with compensated advanced chronic liver disease
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Ruijin Hospital
🇨🇳Shanghai, China
Zagazig University Faculty of Medicine
🇪🇬Zagazig, Egypt
Tianjin Second People's Hospital
🇨🇳Tianjin, China
Hyogo College of Medicine
🇯🇵Nishinomiya, Japan
Korea University Ansan Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Ehime University Graduate School of Medicine
🇯🇵Matsuyama, Japan
Institute of Liver and Biliary Sciences
🇮🇳New Delhi, India