An observational study in Compensated Advanced Chronic Liver Disease, sponsored by Hepatopancreatobiliary Surgery Institute of Gansu Province. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-25.
Sponsored by Hepatopancreatobiliary Surgery Institute of Gansu Province · Observational
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.
345 studies on the registry are indexed under Hypertension, Portal; 110 are open to participants now.
This study's enrollment of 1,000 is above the median of 151 across 128 observational studies indexed under Hypertension, Portal.
Browse Hypertension, Portal studies →Hepatopancreatobiliary Surgery Institute of Gansu Province is the lead sponsor of 44 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This is an international, multicenter cohort study initialed by Portal Hypertension Alliance in China (CHESS) and eligible patients will enroll from China, Japan, Southern Korea, Egypt, Singapore, and India.
Training and Validation cohort
Inclusion Criteria:
Exclusion Criteria:
HVPG cohort.
Inclusion Criteria:
Exclusion Criteria:
Training cohort was used to developement the new algorithm for predicting liver decompensation.
Diagnostic Test: Esophagogasrtoduodendoscopy
Validation cohort was used to test the performance of the new algorithm in predicting liver decompensation.
Diagnostic Test: Esophagogasrtoduodendoscopy
HVPG cohort, a cross-section cohort was used to study the diagnostic value of novel score for clinically significant portal hypertension.
Diagnostic Test: Esophagogasrtoduodendoscopy · Diagnostic Test: Hepatic venous pressure gradient
Esophagogasrtoduodendoscopy was used to detech the presence of varices.
A method used to eveluate the portal pressure
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
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
Plan to share: Undecided
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Hepatopancreatobiliary Surgery Institute of Gansu Province