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

Sponsor
Hepatopancreatobiliary Surgery Institute of Gansu Province (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04975477
Collaborator
LanZhou University (Other), Institute of Liver and Biliary Sciences (ILBS) (Other), Zagazig University (Other), Korea University (Other), Ehime University Graduate School of Medicine (Other), Hyogo College of Medicine (Other), Tianjin Second People's Hospital (Other), Ruijin Hospital (Other)
1,000
Enrollment
7
Locations
1
Anticipated Duration (Months)
142.9
Patients Per Site
140.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Esophagogasrtoduodendoscopy and liver stiffness
  • Procedure: hepatic venous pressure gradient

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 Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
CHESS-SAVE Score to Stratify Decompensation Risk in Compensated Advanced Chronic Liver Disease: an International Multicenter Study (CHESS2102)
Anticipated Study Start Date :
Jul 16, 2021
Anticipated Primary Completion Date :
Aug 16, 2021
Anticipated Study Completion Date :
Aug 16, 2021

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ruijin Hospital Shanghai China
2 Tianjin Second People's Hospital Tianjin China
3 Zagazig University Faculty of Medicine Zagazig Egypt
4 Institute of Liver and Biliary Sciences New Delhi India
5 Ehime University Graduate School of Medicine Matsuyama Japan
6 Hyogo College of Medicine Nishinomiya Japan
7 Korea University Ansan Hospital Gyeonggi-do Korea, Republic of

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Xiaolong Qi, Chief, Hepatopancreatobiliary Surgery Institute of Gansu Province
ClinicalTrials.gov Identifier:
NCT04975477
Other Study ID Numbers:
  • CHESS2102
First Posted:
Jul 23, 2021
Last Update Posted:
Jul 23, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Xiaolong Qi, Chief, Hepatopancreatobiliary Surgery Institute of Gansu Province
liver stiffness
platelets
albumin
varices
compensated cirrhosis
Additional relevant MeSH terms:
Liver Diseases

Study Results

No Results Posted as of Jul 23, 2021