NCT05100485

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
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (actual)
• Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Compensated Advanced Chronic Liver Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-01-01
• Completion: 2023-01-01
• First posted: 2021-10-29
• Last updated: 2023-04-25

Locations

1 site across 1 country: China