Primary Prophylaxis of High-risk Esophageal Gastric Variceal Bleeding Comparing Carvedilol and Endoscopic Therapy: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 792
- 试验地点
- 1
- 主要终点
- Bleeding rate
研究概览
简要总结
To compare the efficacy and safety of Carvedilol and endoscopic therapy in Primary Prophylaxis of High-risk Esophageal Gastric Variceal Bleeding.
详细描述
The study is a randomized controlled trial. Patients randomly enter into two treatment groups: 1)the Carvedilol group and 2)the endoscopy group. Treatment allocation is by block randomization, with an two-to-one ratio for Carvedilol and endoscopy. The results are concealed in opaque envelopes. The dose of Carvedilol is titrated according to systolic arterial blood pressure (ABPsys) and heart rate (HR). Doses are increased every 7 days until ABPsys is not less than 95 mm Hg and HR is not less than 55 bpm. Carvedilol is started at a dose of 6.25 mg/d, and titrated to a maximum dose of 12.5 mg/d. Patients receiving endoscopic therapy every 4 weeks until eradication of varices. Patients will come for clinic visit every 6 months, receiving laboratory tests and endoscopic examinations, and events of primary and secondary outcomes will be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the presence of severe esophageal and gastric varices at upper gastrointestinal endoscopy without a previous haemorrhage
- •a diagnosis of liver cirrhosis based on histology, clinical or imaging manifestation
排除标准
- •age greater than 80 years old or younger than 18 years old
- •non-cirrhotic portal hypertension
- •contraindications to NSBB including bronchospasm, severe bradycardia, severe heart failure, acute pulmonary edema, atrioventricular block and so on
- •ABPsys less than 95 mmHg or HR less than 50 bpm
- •prior treatment for prevention of bleeding from EGV
- •presence of spontaneous bacterial peritonitis or other severe infections
- •presence of hepatorenal syndrome
- •uncontrolled hepatic encephalopathy
- •presence of refractory ascites
- •pregnancy
- •presence of portosystemic shunt or portal cavernous transformation
- •refusal to participate in the study
研究组 & 干预措施
Carvedilol
Carvedilol，6.25mg-12.5mg/d,oral,6-36 months
干预措施: Carvedilol (Drug)
endoscopy
endoscopy，every 4 weeks until eradication of varices
干预措施: endoscopy (Device)
结局指标
主要结局
Bleeding rate
时间窗: through study completion，an average of 18 months
The investigators observe the variceal bleeding events during the study
次要结局
- Mortality rate(through study completion，an average of 18 months)
- Adverse events(through study completion，an average of 18 months)
研究者
Shiyao Chen
Director of department of Gastroenterology, Zhongshan Hospital
Shanghai Zhongshan Hospital