A Novel Algorithm to Stratify Clinical Decompensation Risk in Patients With Compensated Advanced Chronic Liver Disease (CHESS2108)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Accuracy of a novel algorithm for predicting liver decompensation.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Accuracy of a novel algorithm for predicting liver decompensation.
时间窗: 3 years
Aims to investigate the accuracy of the novel algorithm to stratify decompensation risk in patients with cACLD.
次要结局
- The accuracy of the novel alogrithm for predicting clinically significant portal hypertension.(1 years)
研究者
Xiaolong Qi
Prof.
Hepatopancreatobiliary Surgery Institute of Gansu Province