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临床试验/NCT02119988
NCT02119988已完成不适用

Transjugular Intrahepatic Portosystemic Shunt (TIPS) Using Covered Stents Combined With Variceal Embolization in the Prevention of Variceal Rebleeding for Patients With Cirrhosis : a Prospective, Open-labeled, Randomized, Controlled Trial

Air Force Military Medical University, China2 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2014年6月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
134
试验地点
2
主要终点
All-cause rebleeding

研究概览

简要总结

The purpose of this study is to determine whether TIPS combined with variceal embolization are effective in the prevention of variceal rebleeding in patients with liver cirrhosis.

详细描述

Variceal bleeding is one of the leading causes of death in patients with cirrhosis. Patients with cirrhosis surviving a variceal bleeding are at high risk of rebleeding (over 60% at 1 year), and mortality from each rebleeding episode is about 20%.

Placement of TIPS is a well-established technique that is highly effective in preventing recurrent variceal bleeding, especially if the TIPS is created with an expanded polytetrafluoroethylene (ePTFE)-covered stent, which has a significantly lower risk of shunt dysfunction than does TIPS created with bare stents. But the risk of hepatic encephalopathy greatly increases and the risk of recurrent variceal bleeding after TIPS placement remains an issue. Besides an insufficient decrease in portosystemic pressure gradient after TIPS creation alone, fragile variceal vessels also are considered a risk factor for recurrent bleeding.

Accordingly, TIPS combined with variceal embolization has been advocated to achieve the best result possible in preventing recurrent variceal bleeding. However, in recent American Association of the Study of Liver Disease (AASLD) practice guidelines and Baveno V consensus, no treatment strategies were clearly recommended maybe because the exact efficacy of this strategy remains unclear and high-quality randomized controlled trials still lacks.

So the investigators hypothesized that embolization of these collateral vessels may increase the blood flow within the shunt and into the liver, which can theoretically decrease the incidence of shunt dysfunction and encephalopathy, even can prolong the patients' survival.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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

入选标准

  • Signed written informed consent
  • Dignosis of cirrhosis (clinical or by liver biopsy)
  • Admission due to variceal bleeding occurred 5 to 42 days prior and standard treatment for secondary prophylaxis failed
  • Age 18 to 75 years

排除标准

  • Hepatic carcinoma and/or other malignancy diseases
  • Portal vein thrombosis (≥50% of the lumen)
  • Child-Pugh score>13 points
  • Spontaneous recurrent hepatic encephalopathy
  • Budd-Chiari syndrome
  • Large spontaneous portosystemic shunts
  • Spontaneous bacterial peritonitis
  • Uncontrollable hypertension
  • Serious cardiac or pulmonary dysfunction
  • Renal failure
  • With TIPS contraindications
  • Previous TIPS or collateral embolization,
  • Pregnancy or breast-feeding
  • History of organ transplantation

结局指标

主要结局

All-cause rebleeding

时间窗: 2 years

次要结局

  • Hepatic encephalopathy(2 years)
  • Variceal rebleeding(2 years)
  • Liver function changs(2 years)
  • Adverse events(2 years)
  • Shunt dysfunction(2 years)
  • Mortality(2 years)

研究者

发起方
Air Force Military Medical University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guohong Han

M.D., Ph.D.

Air Force Military Medical University, China

研究点 (2)

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