Using Covered Stent of Diameter of 7mm in a Prospective, Single Blind, Randomized, Controlled Study of TIPS(Transjugular Intrahepatic Portosystemic Stent Shunt )
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 216
- 主要终点
- The incidence of hepatic encephalopathy after TIPS
研究概览
简要总结
This study evaluates the incidence of hepatic encephalopathy between covered stent of diameter of 7mm and 8mm in TIPS(transjugular intrahepatic portosystemic stent shunt ).Half of the participants will receive stent of diameter of 7mm ,while the other half will receive stent of diameter of 8mm.
详细描述
TIPS is effective in the treatment of hemorrhage of digestive tract and intractable ascites,which are the complications of cirrhosis. At present, the high incidence of hepatic encephalopathy has been a major problem after TIPS. The high incidence rate of hepatic encephalopathy was closly associated with the diameter of the stent. We often use the stent of diameter 8mm in TIPS.In this study, we try to use the stent of smaller diameter of 7mm in TIPS,and compare the incidence of hepatic encephalopathy between the stent of diameter of 7mm and 8mm .
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 (Participant)
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
- 是
入选标准
- •there is a clear TIPS treatment indications of liver cirrhosis portal hypertension patients of gastrointestinal bleeding.
- •undergoing elective TIPS to treat patients.
- •aged 18-70 years old
排除标准
- •preoperative patients with hepatic encephalopathy.
- •with portal vein thrombosis patients.
- •combined liver malignant tumor or other parts of the patients with malignant tumor.
- •In combination of peptic ulcer bleeding.
研究组 & 干预措施
the stent of diameter of 7mm
Procedure/Surgery:Jugular vein puncture and catheterization. Device:RUPS-100(COOK Company)sheath ,7mm balloon,Pigtail catheter,the stent of diameter of 7mm (Bard,Fluency) Drug(including placebo):No Biological/Vaccine:No
干预措施: the stent of diameter of 7mm (Device)
the stent of diameter of 8mm
Procedure/Surgery:Jugular vein puncture and catheterization. Device:RUPS-100(COOK Company)sheath ,8mm balloon,Pigtail catheter,the stent of diameter of 8mm (Bard,Fluency) Drug(including placebo):No Biological/Vaccine:No
干预措施: the stent of diameter of 8mm (Device)
结局指标
主要结局
The incidence of hepatic encephalopathy after TIPS
时间窗: 1 year
The incidence of hepatic encephalopathy after TIPS in 7day,1,3,6,12month
次要结局
- the incidence of shunt restenosis after TIPS(1 year)
- platelet count in different periods(1 year)
- the recurrence rate of gastrointestinal bleeding after TIPS(1 year)
- Portal venous pressure before and afterTIPS(1 year)
- liver function in different periods(1 year)
- blood ammonia in different periods(1 year)
- jaundice index in different periods(1 year)
研究者
Fuquan Liu
Director,Clinical Research
Beijing Shijitan Hospital, Capital Medical University