NCT02468180Unknown不适用
Primary Prophylaxis of Gastric Variceal Bleed: Endoscopic Cyanoacrylate Injection Versus Balloon-occluded Retrograde Transvenous Obliteration
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Bleeding rate from gastric varices
研究概览
简要总结
The purpose of this study is to study the efficacy of endoscopic cyanoacrylate injection versus balloon-occluded retrograde transvenous obliteration in the prevention of gastric variceal bleeding.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with high risk gastric varices (GOV2 or IGV1)
- •Presence of gastrorenal shunt
排除标准
- •Acute bleed or past history of bleed from gastric varices
- •Previous treatment of gastric varices.
- •Non-cirrhotic portal hypertension
- •Contraindications to cyanoacrylate injection or BRTO
- •Portal cavernoma
- •Hepatorenal syndrome
- •Proven malignancy including hepatocellular carcinoma
- •End-stage renal disease under renal replacement therapy;
- •Cardiorespiratory failure
- •Pregnancy or patients not giving informed consent for endoscopic procedures
研究组 & 干预措施
BRTO
Active Comparator
Balloon-occluded retrograde transvenous obliteration
干预措施: Balloon-occluded retrograde transvenous obliteration (Procedure)
BRTO
Active Comparator
Balloon-occluded retrograde transvenous obliteration
干预措施: Lauromacrogol (Drug)
NBCA
Active Comparator
Endoscopic cyanoacrylate injection
干预措施: Endoscopic cyanoacrylate injection (Procedure)
NBCA
Active Comparator
Endoscopic cyanoacrylate injection
干预措施: N-butyl-2-cyanoacrylate (Drug)
结局指标
主要结局
Bleeding rate from gastric varices
时间窗: 3 years
次要结局
- Number of participants with appearance or worsening of ascites(3 years)
- Number of participants with complication(3 years)
- Eradication rate of gastric varices(3 years)
- Number of participants with increase or decrease in the size of gastric varices(3 years)
- Number of participants with appearance or worsening of new oesophageal varices(3 years)
- Number of participants with appearance or worsening of portal hypertensive gastropathy(3 years)
- Average in-hospital stay(3 years)
- Cost of treatment(3 years)
- Mortality rate(3 years)
研究者
研究点 (1)
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