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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Compensated Advanced Chronic Liver Disease

Intervention / Treatment
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* Diagnostic Test: Esophagogasrtoduodendoscopy
* Diagnostic Test: Hepatic venous pressure gradient


Participation Criteria
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Eligibility Criteria
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Training and Validation cohort Inclusion Criteria: age above or equal to 18-year-old, fulfilled diagnosis of cACLD based on radiological, histological features of severe fibrosis or cirrhosis according to the Baveno VI consensus. Exclusion Criteria: prior hepatic decompensation, hepatocellular carcinoma, prior liver transplantation, portal vein thrombosis, antiplatelet or anticoagulation, without screening endoscopy within six months of transient elastography, alcoholic cirrhosis with significant ongoing alcohol intake, presence of gastric varix, incomplete follow-up data. HVPG cohort. Inclusion Criteria: age above or equal to 18-year-old, fulfilled diagnosis of cACLD based on radiological, histological features of severe fibrosis or cirrhosis according to the Baveno VI consensus. Exclusion Criteria: prior hepatic decompensation, hepatocellular carcinoma, prior liver transplantation, portal vein thrombosis, antiplatelet or anticoagulation, without screening endoscopy within six months of transient elastography, alcoholic cirrhosis with significant ongoing alcohol intake, presence of gastric varix, non-sinusoidal portal hypertension.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Training cohort<br>Training cohort was used to developement the new algorithm for predicting liver decompensation. | Diagnostic Test: Esophagogasrtoduodendoscopy<br>* Esophagogasrtoduodendoscopy was used to detech the presence of varices.<br>|
| Validation cohort<br>Validation cohort was used to test the performance of the new algorithm in predicting liver decompensation. | Diagnostic Test: Esophagogasrtoduodendoscopy<br>* Esophagogasrtoduodendoscopy was used to detech the presence of varices.<br>|
| HVPG cohort<br>HVPG cohort, a cross-section cohort was used to study the diagnostic value of novel score for clinically significant portal hypertension. | Diagnostic Test: Esophagogasrtoduodendoscopy<br>* Esophagogasrtoduodendoscopy was used to detech the presence of varices.<br>Diagnostic Test: Hepatic venous pressure gradient<br>* A method used to eveluate the portal pressure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver stiffness, platelets, portal hypertension, varices, compensated advanced chronic liver disease