• Algorithm to Stratify Clinical Decompensation Risk in Patients With Compensated Advanced Chronic Liver Disease (CHESS2108)

  NCT05100485

  CompletedObservationalUpdated Apr 25, 2023
• CHESS Criteria for Varices Screening in Compensated Advanced Chronic Liver Disease (CHESS2001/APPHA2001)

  NCT04307264

  CompletedObservationalUpdated Apr 25, 2023
• A Combined Model Based on Spleen Stiffness, Liver Stiffness and Platelets for Assessing Portal Hypertension in Compensated Cirrhosis (CHESS2202)

  NCT05251272

  Unknown statusObservationalUpdated Apr 25, 2023
• Spleen Stiffness Combined With Liver Stiffness Measured by 2D-SWE for the Screening of High-risk Varices in Compensated Advanced Chronic Liver Disease (CHESS2004)

  NCT04546360

  CompletedObservationalUpdated Sep 5, 2024
• A Novel Spleen-dedicated Stiffness Measured by FibroScan to Evaluate Cirrhotic Portal Hypertension (CHESS2105)

  NCT05052892

  Unknown statusObservationalUpdated Apr 25, 2023
• Non-invasive Evaluation of Portal Hypertension in Patients With Compensated Advanced Chronic Liver Disease by Assessment of Spleen Stiffness Using VCTE by FibroScan.

  NCT03778411

  CompletedObservationalUpdated Apr 19, 2024

ClinicalTrials.gov ID

NCT04975477

Lead Sponsor

Hepatopancreatobiliary Surgery Institute of Gansu ProvinceOTHER

Overall Status

Unknown status

Study Type

Observational

Enrollment

1,000Estimated

Last Update Posted

Jul 23, 2021Actual

Start Date

Jul 16, 2021Estimated

Primary Completion Date

Aug 16, 2021Estimated

Completion Date

Aug 16, 2021Estimated

Official Title

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

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.

• Compensated Advanced Chronic Liver Disease

• Esophagogasrtoduodendoscopy and liver stiffness
• hepatic venous pressure gradient

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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.

Observational Model

Cohort

Time Perspective

Retrospective

Lead Sponsor

Hepatopancreatobiliary Surgery Institute of Gansu ProvinceOTHER

Collaborators

LanZhou UniversityOTHER

Institute of Liver and Biliary Sciences (ILBS)UNKNOWN

Zagazig UniversityOTHER_GOV

Korea UniversityOTHER

Ehime University Graduate School of MedicineOTHER

Hyogo Medical UniversityOTHER

Tianjin Second People's HospitalOTHER

Ruijin HospitalOTHER

18622663700@163.com

shivsarin@gmail.com

enomoto@hyo-med.ac.jp

gudwns21@korea.ac.kr