Influence of Shunt Occlusion on Organ Functions in Hyperammonemic Patients With Cirrhosis Having Porto-systemic Shunt. A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Increase in liver volume by CT Volumetry.
研究概览
简要总结
The spontaneous Porto-systemic shunt is occluded by intervention procedures like Balloon Occluded Retrograde Transvenous Obliteration (BRTO), Plug-assisted Retrograde Transvenous Obliteration (PARTO) and shunt occlusion procedures resulting in diversion of blood flow towards the portal circulation and in turn the liver. According to this investigator hypothesized that shunt occlusion improves liver volume and function along with beneficial effect on other organ systems by decreasing ammonia and improving hepatopetal flow. All patients with cirrhosis having large shunt(>10mm) and raised ammonia levels and will be randomized to receive standard medical treatment and those receiving shunt occlusion procedures. Investigator will assess organ functions and liver regenerative potential pre and post (after 3 to 15 months) procedure.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent to participate in the study
- •Age 18 to 70 years
- •Cirrhotic patients with large shunts (>10mm) and hyperammonemia (arterial ammonia >1.5 x N)
排除标准
- •Intractable ascites
- •Hepatocellular Carcinoma
- •Portal Vein Thrombosis or splenic vein thrombosis
- •High risk esophageal varices
- •Pregnant and lactation
- •Significant heart or respiratory failure
- •Active gastrointestinal bleeding
- •Refusal to participate in study
结局指标
主要结局
Increase in liver volume by CT Volumetry.
时间窗: 3 to 15 months
次要结局
- Improvement in T Score(3 to 15 months)
- Reduction in MELD (Model for End Stage Liver Disease) in both groups(3 to 15 months)
- Reduction in Plasma ammonia levels in both groups(3 to 15 months)