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

Completed

• Conditions: Compensated Advanced Chronic Liver Disease
• Interventions: Diagnostic Test: Esophagogasrtoduodendoscopy; Diagnostic Test: Hepatic venous pressure gradient

• Registration Number: NCT05100485
• Lead Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province

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.

Study Timeline

• Study First Submitted: 2021-10-20
• Study First Submitted QC: 2021-10-20
• Study First Posted: 2021-10-29
• Study Start: 2022-01-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-23
• Last Update Posted: 2023-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Validation cohort	Esophagogasrtoduodendoscopy	Validation cohort was used to test the performance of the new algorithm in predicting liver decompensation.
HVPG cohort	Esophagogasrtoduodendoscopy	HVPG cohort, a cross-section cohort was used to study the diagnostic value of novel score for clinically significant portal hypertension.
Training cohort	Esophagogasrtoduodendoscopy	Training cohort was used to developement the new algorithm for predicting liver decompensation.
HVPG cohort	Hepatic venous pressure gradient	HVPG cohort, a cross-section cohort was used to study the diagnostic value of novel score for clinically significant portal hypertension.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Zhongda Hospital; 🇨🇳 Nanjing, Jiangsu, China