CHESS-SAVE Score to Stratify Decompensation Risk in Compensated Advanced Chronic Liver Disease (CHESS2102)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Compensated Advanced Chronic Liver Disease

Intervention / Treatment
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* Procedure: Esophagogasrtoduodendoscopy and liver stiffness
* Procedure: hepatic venous pressure gradient


Participation Criteria
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Eligibility Criteria
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Training and validation 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; 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Training cohort<br>A cohort was used to develop the novel score for predicting liver decompensation | Procedure: Esophagogasrtoduodendoscopy and liver stiffness<br>* Time frame between elastography measurement and esophagogastroduodendoscopy is within 6 months.<br>|
| Validation cohort<br>A cohort was used to validate the performance of novel score for predicting liver decompensation | Procedure: Esophagogasrtoduodendoscopy and liver stiffness<br>* Time frame between elastography measurement and esophagogastroduodendoscopy is within 6 months.<br>|
| Exploratory cohort<br>A cohort was used to study the diagnostic value of novel score for clinically significant portal hypertension | Procedure: Esophagogasrtoduodendoscopy and liver stiffness<br>* Time frame between elastography measurement and esophagogastroduodendoscopy is within 6 months.<br>Procedure: hepatic venous pressure gradient<br>* A method was used to evaluate portal pressure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of the CHESS-SAVE score for predicting liver decompensation | To assess the accuracy of the CHESS-SAVE score to predict liver decompensation in patients with compensated advanced chronic liver disease | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver stiffness, platelets, albumin, varices, compensated cirrhosis