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

July 14, 2021 updated by: Xiaolong Qi, Hepatopancreatobiliary Surgery Institute of Gansu Province

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Ruijin Hospital
      • Tianjin, China
  • Egypt
      • Zagazig, Egypt
        • Zagazig University Faculty of Medicine
  • India
      • New Delhi, India
  • Japan
      • Matsuyama, Japan
        • Ehime University Graduate School of Medicine
      • Nishinomiya, Japan
  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients were fulfilled diagnosis of cACLD based on radiological, histological features of liver cirrhosis.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province

Collaborators

Zagazig University
LanZhou University
Korea University
Ruijin Hospital
Hyogo College of Medicine
Tianjin Second People's Hospital
Ehime University Graduate School of Medicine
Institute of Liver and Biliary Sciences (ILBS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 16, 2021

Primary Completion (ANTICIPATED)

August 16, 2021

Study Completion (ANTICIPATED)

August 16, 2021

Study Registration Dates

First Submitted

July 14, 2021

First Submitted That Met QC Criteria

July 14, 2021

First Posted (ACTUAL)

July 23, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 23, 2021

Last Update Submitted That Met QC Criteria

July 14, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHESS2102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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