A Randomised Controlled Trial to Study the Efficacy and Safety of TIPS (Trans Intrahepatic Portosystemic Shunt) Versus Self Expanding Metallic Stent (SEMS) in the Management of Refractory Variceal Bleed in Cirrhotics.
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Survival in both groups
研究概览
简要总结
A total of 50 patients will be enrolled and will be randomized into either Group A(TIPS) or Group B (SEMS).
Primary end point of the study will be to compare efficacy of TIPS versus SEMS for survival at 6 week or Early re Bleed. All enrolled patients will also undergo HVPG measurement at baseline to stratify risk of failure to control bleed or early re-bleed.
Patient will be monitored for 5 days for re bleed, complications of therapy, worsening of Liver function tests and scores and efficacy of either treatment modality over other. Patient will be followed for 6 weeks to see for the primary end point.
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
- •Consecutive patients of cirrhosis aged 18-70 years presenting with acute variceal Bleeding, who on endoscopy fail to control bleed or rebleeds within 5 days will be randomized.
排除标准
- •Bleeding from non-variceal source
- •Coagulopathy related bleed
- •Bleeding from Gastric varices
- •Any malignancy including HCC
- •Main Portal vein thrombosis
- •Patients in refractory shock
- •Patients with severe cardiopulmonary disease
- •Grade 4 Hepatic encephalopathy
- •MELD > 25
- •Multiorgan failure
- •Active sepsis
- •Pregnancy
- •Failure to give consent
研究组 & 干预措施
TIPS + Vasoactive Drug
干预措施: Trans Intrahepatic Portosystemic Shunt (Procedure)
TIPS + Vasoactive Drug
干预措施: Vasoactive Agent (Drug)
SEMS + Vasoactive Drug
干预措施: Self Expanding Metallic Stent (Procedure)
SEMS + Vasoactive Drug
干预措施: Vasoactive Agent (Drug)
结局指标
主要结局
Survival in both groups
时间窗: 6 weeks
次要结局
- Worsening of liver severity score in both groups.(6 weeks)
- Re-bleeding in both groups for 5 days from end of therapy(5 days)
- Rebleeding in both groups(6 weeks)
- Decompensation in both groups in the form of ascites or Hepatic Encephalopathy(6 weeks)
- Adverse events in both groups(6 weeks)