NCT05538546尚未招募不适用
The Value of Baveno VI Criteria for Screening and Monitoring of Varices Needing Treatment in Patients With Compensated Cirrhosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 主要终点
- The missing rate of Baveno criteria at 12th month follow-up visit
研究概览
简要总结
Patients meet Baveno VI criteria (with a liver stiffness <20kPa and with a platelet count >150,000 are considered to have very low risk of having varices requiring treatment, but whether these patients can be followed up by repetition of this criteria lacks sufficient evidence. This study aimed to assess the value of Baveno VI criteria for following up and monitoring of varices needing treatment in patients with compensated cirrhosis.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with liver cirrhosis diagnosed according to clinical or pathological criteria;
- •No decompensation events in the past, no ascites shown by ultrasound, no significant abnormality in liver function and coagulation function;
- •Willing to carry out routine diagnosis and treatment evaluation and follow-up liver stiffness test and gastroscopy;
- •Patients meet Baveno VI criteria (with a liver stiffness <20kPa and with a platelet count >150,000) at baseline, or patients don't meet Baveno VI criteria (with a liver stiffness ≥ 20kPa or with a platelet count ≤150,000) at baseline, but don't have varices requiring treatment (proved by endoscopy).
- •Voluntarily signed the informed consent.
排除标准
- •Patients with liver carcinoma;
- •Patients with portal vein thrombosis;
- •Patients with varices requiring treatment confirmed by gastroscopy during the screening period;
- •Patients who have received propranolol, ligation, sclerosis, splenectomy, transcatheter splenic arterial embolization, transjugular interhepatic portosystemicstent-shunt and other treatments to decrease portal hypertension in the past.
结局指标
主要结局
The missing rate of Baveno criteria at 12th month follow-up visit
时间窗: 12 months from baseline
The number of patients with varices requiring treatment under endoscopy divided by the number of patients meet Baveno criteria at 12th month follow-up visit
次要结局
- The missing rate of Baveno criteria at 24th month follow-up visit(24 months from baseline)
- Cumulative rate of decompensation events(24 months from baseline)
- Cumulative rate of gastrointestinal bleeding(24 months from baseline)
- Cumulative rate of 6-week death post gastrointestinal bleeding(24 months from baseline)
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