Transjugular Intrahepatic Portosystemic Shunt (TIPS) for Variceal Rebleeding in Cirrhotic Patients With Occlusive Portal Vein Thrombosis (PVT) and Cavernous Transformation of the Portal Vein (CTPV)
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Variceal rebleeding
研究概览
简要总结
To date, there is no treatment strategies for these patients according to American Association of the Study of Liver Disease (AASLD) practice guidelines and Baveno V consensus. Thus, we aim to compare the safety and efficacy of TIPS and conservative treatment (non-selective beta blockers, endoscopic therapy and/or anticoagulation) in patients with PVT and CPTV.
详细描述
The incidence of portal vein thrombosis (PVT) is about 16% in cirrhotic patients. Chronic PVT often cause two main undesirable consequences: symptomatic portal hypertension (such as variceal bleeding or ascites) and cavernous transformation of portal vein (CPTV). The former could lead to death and the latter increases the difficulty of the transjugular intrahepatic portosystemic shunt (TIPS) treatment, which is considered as a main effective treatment for symptomatic portal hypertension. Some patients with CPTV and variceal bleeding only have to receive conservative treatment (non-selective beta blockers, endoscopic therapy and/or anticoagulation). With advances in technology, modified TIPS procedure could significantly improve the operation success rate of patients with CPTV. To date, the difference in safety and efficacy between TIPS and conservative treatment (non-selective beta blockers, endoscopic therapy and/or anticoagulation) in patients with PVT and CPTV is still unclear.
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
- 14 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients diagnosis with portal vein thrombosis and cavernous transformation of portal vein and portal hypertension by contrast enhanced CT or MRI.
- •History of variceal bleeding.
- •Liver cirrhosis.
- •Neutrophilous counts≥ 1.5×109/L, Platelet counts ≥ 50 × 109/L, Hemoglobin≥ 85g/L.
- •Albumin ≥2.8 g/dL, total bilirubin <51.3 umol/L; alanine aminotransferase (ALT) and aspartate transaminase（AST）<5 times of upper limit.
- •PT(Prothrombin time)-INR(international normalized ratio) < 1.7.
排除标准
- •Thrombosis involve superior mesenteric vein, splenic vein, or the whole portal vein system. Not suitable for TIPS (judged by principal investigator).
- •Company with malignant tumors in liver or other organs.
- •Patients with known severe dysfunction of heart, lung, brain or kidney.
- •Active bleeding.
- •Not eligible for anticoagulation therapy,non-selective beta blockers or endoscopic therapy.
- •Uncontrolled infection.
- •Pregnancy and breastfeeding.
- •HIV infection.
研究组 & 干预措施
TIPS arm
Transjugular intrahepatic portosystemic shunt(TIPS) is an artificial channel within the liver that establishes communication between the inflow portal vein and the outflow hepatic vein. It is used to treat portal hypertension.TIPS was performed in a conventional fashion or in combination of percutaneous transhepatic or transsplenic approach (also called p-TIPS or modified TIPS). Oral warfarin was used for six months to one year prescribed at dosages to achieve an international normalized ratio (INR) of up to two times the upper limit of normal for the prevention of shunt dysfunction.
干预措施: TIPS (Procedure)
TIPS arm
Transjugular intrahepatic portosystemic shunt(TIPS) is an artificial channel within the liver that establishes communication between the inflow portal vein and the outflow hepatic vein. It is used to treat portal hypertension.TIPS was performed in a conventional fashion or in combination of percutaneous transhepatic or transsplenic approach (also called p-TIPS or modified TIPS). Oral warfarin was used for six months to one year prescribed at dosages to achieve an international normalized ratio (INR) of up to two times the upper limit of normal for the prevention of shunt dysfunction.
干预措施: Warfarin (Drug)
conservative treatment arm
Conservative treatment including endoscopic therapy，non-selective beta blockers (propranolol)and anticoagulation therapy (warfarin).
干预措施: Propranolol (Drug)
conservative treatment arm
Conservative treatment including endoscopic therapy，non-selective beta blockers (propranolol)and anticoagulation therapy (warfarin).
干预措施: Endoscopic therapy (Procedure)
conservative treatment arm
Conservative treatment including endoscopic therapy，non-selective beta blockers (propranolol)and anticoagulation therapy (warfarin).
干预措施: Warfarin (Drug)
结局指标
主要结局
Variceal rebleeding
时间窗: 3 years
Variceal rebleeding rate in 3 years
次要结局
- Overall survival time(3 years)
- Transjugular intrahepatic portosystemic shunt success rate(3 years)
- Treatment-related complications(3 years)
- Variceal rebleeding-related death rate(3 years)
研究者
Zaibo Jiang
Head of the intervention and vascular surgery department, the Third Affiliated Hospital, Sun Yat-sen University
Sun Yat-sen University