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

April 23, 2023 updated by: Xiaolong Qi, Hepatopancreatobiliary Surgery Institute of Gansu Province

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

Compensated advanced chronic liver disease (cACLD) commonly indicates severe fibrosis and compensated cirrhosis at risk of developing clinically significant portal hypertension (CSPH) and hepatic decompensation. The presence of CSPH (defined as hepatic venous pressure gradient [HVPG] ≥ 10 mmHg) is the strongest predictor of hepatic decompensation. However, HVPG measurement is invasive, operator dependent, and not widely available. According to the 2021 updated EASL Clinical Practice Guidelines, cACLD patients who did not meet the Baveno VI criteria but had any of the two variables (LSM > 20 kPa or PLT < 150 × 109/L) were suggested to perform screening endoscopy and HVPG measurement. However, the number of cACLD patients with unfavorable Baveno VI status is huge, no detailed risk stratifications existed at this timepoint. This study intended to investigate a novel algorithm to stratify the decompensation risk in patients with cACLD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Compensated advanced chronic liver disease (cACLD) commonly indicates severe fibrosis and compensated cirrhosis at risk of developing clinically significant portal hypertension (CSPH) and hepatic decompensation. The presence of CSPH (defined as hepatic venous pressure gradient [HVPG] ≥ 10 mmHg) is the strongest predictor of hepatic decompensation. However, HVPG measurement is invasive, operator dependent, and not widely available. According to the 2021 updated EASL Clinical Practice Guidelines, cACLD patients who did not meet the Baveno VI criteria but had any of the two variables (LSM > 20 kPa or PLT < 150 × 109/L) were suggested to perform screening endoscopy and HVPG measurement. However, the number of cACLD patients with unfavorable Baveno VI status is huge, no detailed risk stratifications existed at this timepoint. This international multicenter cohort study intended to investigate a novel algorithm to stratify the decompensation risk in patients with cACLD.

Study Type

Observational

Enrollment (Actual)

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

  • Name: Chuan Liu, MD
  • Phone Number: +8615626415443 +8615626415443
  • Email: 845424585@qq.com

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Zhongda Hospital

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

Sampling Method

Non-Probability Sample

Study Population

This is an international, multicenter cohort study initialed by Portal Hypertension Alliance in China (CHESS) and eligible patients will enroll from China, Japan, Southern Korea, Egypt, Singapore, and India.

Description

Training and Validation cohort

Inclusion Criteria:

  1. age above or equal to 18-year-old,
  2. fulfilled diagnosis of cACLD based on radiological, histological features of severe fibrosis or cirrhosis according to the Baveno VI consensus.

Exclusion Criteria:

  1. prior hepatic decompensation,
  2. hepatocellular carcinoma,
  3. prior liver transplantation,
  4. portal vein thrombosis,
  5. antiplatelet or anticoagulation,
  6. without screening endoscopy within six months of transient elastography,
  7. alcoholic cirrhosis with significant ongoing alcohol intake,
  8. presence of gastric varix,
  9. incomplete follow-up data.

HVPG cohort.

Inclusion Criteria:

  1. age above or equal to 18-year-old,
  2. fulfilled diagnosis of cACLD based on radiological, histological features of severe fibrosis or cirrhosis according to the Baveno VI consensus.

Exclusion Criteria:

  1. prior hepatic decompensation,
  2. hepatocellular carcinoma,
  3. prior liver transplantation,
  4. portal vein thrombosis,
  5. antiplatelet or anticoagulation,
  6. without screening endoscopy within six months of transient elastography,
  7. alcoholic cirrhosis with significant ongoing alcohol intake,
  8. presence of gastric varix,
  9. 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
Training cohort was used to developement the new algorithm for predicting liver decompensation.
Diagnostic test: Esophagogasrtoduodendoscopy
Esophagogasrtoduodendoscopy was used to detech the presence of varices.
Validation cohort
Validation cohort was used to test the performance of the new algorithm in predicting liver decompensation.
Diagnostic test: Esophagogasrtoduodendoscopy
Esophagogasrtoduodendoscopy was used to detech the presence of varices.
HVPG cohort
HVPG cohort, a cross-section cohort was used to study the diagnostic value of novel score for clinically significant portal hypertension.
Diagnostic test: Esophagogasrtoduodendoscopy
Esophagogasrtoduodendoscopy was used to detech the presence of varices.
Diagnostic test: Hepatic venous pressure gradient
A method used to eveluate the portal pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of a novel algorithm for predicting liver decompensation.
Time Frame: 3 years
Aims to investigate the accuracy of the novel algorithm to stratify decompensation risk in patients with cACLD.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The accuracy of the novel alogrithm for predicting clinically significant portal hypertension.
Time Frame: 1 years
HVPG cohort was used to evaluate the accuracy of the novel alogrithm for predicting clinically significant portal hypertension.
1 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

Ruijin Hospital
Changi General Hospital
Korea University Ansan Hospital
Tianjin Second People's Hospital
The Third People's Hospital of Taiyuan
Ehime University Graduate School of Medicine
Zagazing University Faculty of Medicine
Institute of Liver and Biliary Sciences (ILBS)
Hyogo Medical University

Investigators

  • Principal Investigator: Hirayuki Enomoto, MD, Hyogo Medical University

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 (Actual)

January 1, 2022

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

October 20, 2021

First Submitted That Met QC Criteria

October 20, 2021

First Posted (Actual)

October 29, 2021

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 23, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHESS2108

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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