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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04975477
Enrollment
1000
Registered
2021-07-23
Start date
2021-07-16
Completion date
2021-08-16
Last updated
2021-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Compensated Advanced Chronic Liver Disease

Keywords

liver stiffness, platelets, albumin, varices, compensated cirrhosis

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.

Interventions

PROCEDUREEsophagogasrtoduodendoscopy and liver stiffness

Time frame between elastography measurement and esophagogastroduodendoscopy is within 6 months.

A method was used to evaluate portal pressure.

Sponsors

LanZhou University
CollaboratorOTHER
Institute of Liver and Biliary Sciences (ILBS)
CollaboratorUNKNOWN
Zagazig University
CollaboratorOTHER_GOV
Korea University
CollaboratorOTHER
Ehime University Graduate School of Medicine
CollaboratorOTHER
Hyogo Medical University
CollaboratorOTHER
Tianjin Second People's Hospital
CollaboratorOTHER
Ruijin Hospital
CollaboratorOTHER
Hepatopancreatobiliary Surgery Institute of Gansu Province
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of the CHESS-SAVE score for predicting liver decompensation3 yearsTo assess the accuracy of the CHESS-SAVE score to predict liver decompensation in patients with compensated advanced chronic liver disease

Countries

China, Egypt, India, Japan, South Korea

Contacts

Primary ContactXiaolong Qi, MD
qixiaolong@vip.163.com+8618588602600
Backup ContactChuan Liu, MD
845424585@qq.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026