Algorithm to Stratify Clinical Decompensation Risk in Patients With Compensated Advanced Chronic Liver Disease (CHESS2108)
NCT05100485 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1000
Last updated 2023-04-25
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.
Conditions
- Compensated Advanced Chronic Liver Disease
Interventions
- 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
Sponsors & Collaborators
-
Tianjin Second People's Hospital
collaborator OTHER -
The Third People's Hospital of Taiyuan
collaborator OTHER -
Ehime University Graduate School of Medicine
collaborator OTHER -
Korea University Ansan Hospital
collaborator OTHER -
Hyogo Medical University
collaborator OTHER -
Zagazing University Faculty of Medicine
collaborator UNKNOWN -
Institute of Liver and Biliary Sciences (ILBS)
collaborator UNKNOWN -
Changi General Hospital
collaborator OTHER -
Ruijin Hospital
collaborator OTHER -
Hepatopancreatobiliary Surgery Institute of Gansu Province
lead OTHER
Principal Investigators
-
Xiaolong Qi, MD · Lanzhou University First Affiliated Hospital
-
Qing Xie, MD · Shanghai Jiao Tong university affiliated Ruijin Hospital
-
Jia Li, MD · Tianjin Second People's Hospital
-
Yu Jun Wong, MD · Changi General Hospital
-
Masashi Hirooka, MD · Ehime University Graduate School of Medicine
-
Hirayuki Enomoto, MD · Hyogo Medical University
-
Tae Hyung Kim, MD · Korea UniversityAnsan Hospital
-
Amr Shaaban Hanafy, MD · Zagazig University
-
Ying Guo, MD · The Third People's Hospital of Taiyuan
-
Shiv Sarin, MD · Institute of Liver and Biliary Sciences (ILBS)
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-01
- Primary Completion
- 2023-01-01
- Completion
- 2023-01-01
Countries
- China
Study Locations
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