Cost-Effectiveness and Validation of Baveno VIII Criteria for Detecting Clinically Significant Portal Hypertension in Egyptian Patients With Compensated Advanced Chronic Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 125
- 主要终点
- Prevalence of esophageal varices
研究概览
简要总结
This prospective observational study aims to validate Baveno VIII criteria for detection of clinically significant portal hypertension and to evaluate additional predictors of esophageal varices in Egyptian patients with compensated advanced chronic liver disease and liver stiffness measurement between 15 and 25 kPa.
详细描述
Non-invasive criteria based on liver stiffness measurement and platelet count are recommended for identifying clinically significant portal hypertension. Patients with liver stiffness between 15 and 25 kPa represent an indeterminate group.
This observational study will include adult patients with compensated advanced chronic liver disease and liver stiffness measurement of 15-25 kPa. All eligible participants will undergo upper gastrointestinal endoscopy to detect esophageal varices. The performance of Baveno VIII criteria and additional clinical predictors will be evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 18 years or older
- •Compensated advanced chronic liver disease (cACLD)
- •Liver stiffness measurement by VCTE under fasting conditions
- •Liver stiffness measurement between 15 and 25 kPa
- •Eligible for upper gastrointestinal endoscopy
- •Written informed consent
排除标准
- •- Previous variceal bleeding or band ligation
- •TIPS, hepatocellular carcinoma, or portal vein thrombosis
- •Acute liver failure
- •Overt hepatic encephalopathy
- •Severe ascites affecting LSM reliability
- •Concurrent viral hepatitis and MASLD
- •Pregnancy or refusal to undergo endoscopy
研究组 & 干预措施
Single cohort: Patients with cACLD and LSM 15-25 kPa
Adult patients with compensated advanced chronic liver disease and liver stiffness measurement between 15 and 25 kPa who will undergo upper gastrointestinal endoscopy.
结局指标
主要结局
Prevalence of esophageal varices
时间窗: Baseline
Proportion of patients with esophageal varices detected by upper gastrointestinal endoscopy among those with liver stiffness measurement 15-25 kPa.
次要结局
- Prevalence of varices needing treatment(Baseline)
- Mean liver stiffness measurement(Baseline)
- Mean platelet count(Baseline)
- Diagnostic performance of ANTICIPATE model(Baseline)
- Proportion of patients meeting Baveno VIII rule-out criteria(Baseline)
研究者
Marven Joseph Louis Agrabas
Resident Physician, Department of Tropical Medicine & Gastroenterology
Assiut University