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

Hepatopancreatobiliary Surgery Institute of Gansu Province1,000 enrolled

Overview

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.

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

1,000

Conditions

Compensated Advanced Chronic Liver Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Accuracy of a novel algorithm for predicting liver decompensation.

Aims to investigate the accuracy of the novel algorithm to stratify decompensation risk in patients with cACLD.

Time frame: 3 years

Secondary Outcomes

The accuracy of the novel alogrithm for predicting clinically significant portal hypertension.

HVPG cohort was used to evaluate the accuracy of the novel alogrithm for predicting clinically significant portal hypertension.

Time frame: 1 years