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

Hepatopancreatobiliary Surgery Institute of Gansu Province

Status: Unknown

Conditions: Compensated Advanced Chronic Liver Disease

Treatments: Procedure: Esophagogasrtoduodendoscopy and liver stiffness; Procedure: hepatic venous pressure gradient

Study type: Observational

Funder types: Other

Identifiers

NCT04975477

CHESS2102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

1,000 participants in 3 patient groups

Training cohort

Description:

A cohort was used to develop the novel score for predicting liver decompensation

Treatment:

Procedure: Esophagogasrtoduodendoscopy and liver stiffness

Validation cohort

Description:

A cohort was used to validate the performance of novel score for predicting liver decompensation

Treatment:

Procedure: Esophagogasrtoduodendoscopy and liver stiffness

Exploratory cohort

Description:

A cohort was used to study the diagnostic value of novel score for clinically significant portal hypertension

Treatment:

Procedure: Esophagogasrtoduodendoscopy and liver stiffness

Procedure: hepatic venous pressure gradient