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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05100485

Enrollment

1000

Registered

2021-10-29

Start date

2022-01-01

Completion date

2023-01-01

Last updated

2023-04-25

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, portal hypertension, varices, compensated advanced chronic liver disease

Brief summary

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.

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.

Interventions

DIAGNOSTIC_TESTEsophagogasrtoduodendoscopy

Esophagogasrtoduodendoscopy was used to detech the presence of varices.

DIAGNOSTIC_TESTHepatic venous pressure gradient

A method used to eveluate the portal pressure

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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.

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results

None listed

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