Randomized Study With Medico-economic Evaluation Comparing the Use of PTFE Covered Stents vs Naked Stent in the TIPS (Transjugular Intra-hepatic Porto-systemic Shunt)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 22
- 主要终点
- TIPS permeability rate
研究概览
简要总结
Transjugular intrahepatic portosystemic shunts (TIPS) have been increasingly used for the treatment of complications of portal hypertension in patients with cirrhosis.
The initial experiment of the TIPS was reported during the 1990s with stents of various brands, manufacture and sizes, but all "non covered", thus owing the pseudointimal hyperplasia growing inside the stent, which progressively decreases the diameter of the shunt and thus its efficacy. Since the beginning of the 2000s, appeared stents known as "covered" by polytetrafluoroethylene (PTFE) designed to reduce the obstruction rate and thus the frequency shunt revisions. However, these stents are, on average, 2.5 times more expensive than the non covered stents and the cost-effectiveness ratio of the TIPS according to the type of stents used has not been assessed.
The aim of this multicentric and randomized study is to assess the cost-effectiveness ratio of these 2 principles of TIPS, the one using stents covered by PTFE, relatively expensive but seldom becoming obstructed, and the other using non covered stents, less expensive than PTFE but requiring regular gestures of redilatation.
Population concerned: Patients with a cirrhotic portal hypertension responsible for:
- recurrent variceal bleeding
- refractory ascite (or hydrothorax)
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of a cirrhosis as documented by previous liverbiopsy or typical clinical signs
- •Indication validated of the TIPS (Bavéno IV), except not-controlled acute hemorrhagic :
- •Recurrent variceal bleeding after failure of the usual pharmacological and endoscopic methods
- •Refractory or recurrent ascites or difficult to treat
- •Refractory Hydrothorax
排除标准
- •Non cirrhotic HTP
- •CHILD C ≥12
- •Complete portal vein thrombosis
- •Usual contra-indication for TIPS :
- •Known or suspected Hepatocarcinoma by increase of the alpha-foetoprotein >100 UI/mL associated with the presence of at least one hepatic nodule
- •Cardiac insufficiency defined by a ventricular fraction of ejection < 40% with the echocardiography preliminary to the procedure
- •Pulmonary arterial hypertension (PAP > 40 mmHg)
- •Hepatic polycystosis
- •Intra-hepatic bile ducts dilatation,
- •Spontaneous clinical recurrent hepatic encephalopathy
研究组 & 干预措施
A
Naked Stents
干预措施: Naked Stents: Wallstent® (Boston Scientific), Luminexx® (Bard), Zilver® (Cook), Palmaz Genesis® and Smart Control® (Cordis) (Device)
A
Naked Stents
干预措施: Transjugular intrahepatic portosystemic shunt (TIPS) (Procedure)
B
PTFE Covered Stents
干预措施: PTFE Covered Stents: Fluency® (Bard), Advanta V12® (Atrium) and Viatorr® (Gore) (Device)
B
PTFE Covered Stents
干预措施: Transjugular intrahepatic portosystemic shunt (TIPS) (Procedure)
结局指标
主要结局
TIPS permeability rate
时间窗: one year
Cost of the TIPS and patient care according to the type of stent used brought back to an indicator of effectiveness
时间窗: one year
次要结局
- Quality of life(one year)
- Effectiveness criteria : survival rate - recurrence rate of the symptoms having justified the TIPS - various types of dysfunction(one year)
- Doppler : performance evaluation of Doppler for the diagnosis of dysfunction(one year)
- Tolerance criteria : frequency of early complications like early thrombosis - probability of hepatic encephalopathy occurrence and gravity(one year)