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

• Conditions: Compensated Advanced Chronic Liver Disease

• 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.

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-14
• Study First Submitted QC: 2021-07-14
• Last Update Submitted: 2021-07-14
• Study Start: 2021-07-16
• Study First Posted: 2021-07-23
• Last Update Posted: 2021-07-23
• Primary Completion: 2021-08-16
• Study Completion: 2021-08-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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

Trial Locations

Locations (7)

Ruijin Hospital; 🇨🇳 Shanghai, China

Tianjin Second People's Hospital; 🇨🇳 Tianjin, China

Zagazig University Faculty of Medicine; 🇪🇬 Zagazig, Egypt

Institute of Liver and Biliary Sciences; 🇮🇳 New Delhi, India

Ehime University Graduate School of Medicine; 🇯🇵 Matsuyama, Japan

Hyogo College of Medicine; 🇯🇵 Nishinomiya, Japan

Korea University Ansan Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of