Transjugular Intrahepatic Portosystemic Shunt Versus Endoscopic Treatment Combined With Propranolol for Prevention of Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Number of participants with variceal rebleeding
研究概览
简要总结
Portal vein thrombosis (PVT) refers to an obstruction in the trunk of the portal vein. It can extend downstream to the portal branches, or upstream to the splenic and/or the mesenteric veins. The prevalence of PVT is 10-25% and incidence is about 16% in cirrhotic patients. Recent studies demonstrate that the presence of PVT is not only an independent predictor of failure to control active variceal bleeding and prevent variceal rebleeding, but also significantly associated with increased mortality in patients with liver cirrhosis.
However, in recent American Association of the Study of Liver Disease (AASLD) practice guidelines and Baveno V consensus, no treatment strategies in cirrhotic patients with PVT was clearly recommended due to the absence of randomized controlled trials.
详细描述
Usually, cirrhotic patients with PVT are submitted to variceal rebleeding prophylaxis with endoscopic band ligation combined with non-selective beta-blockers and, when necessary, the anticoagulation is started after the varices eradication.
TIPS is just regarded as the second-line therapy for the secondary prophylaxis of variceal bleeding in cirrhotic patients. However, this indication might be changed in the setting of PVT. Indeed, the risk to benefit ratio of TIPS in cirrhotic patients with PVT for the prevention of recurrent variceal bleeding has never been evaluated.
The aim of this study is to compare the efficacy and safety of TIPS and endoscopic band ligation + propranolol in decompensated cirrhosis patients with PVT and a history of variceal bleeding in the past 6 weeks.
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
- •Written informed consent
- •Liver cirrhosis
- •Portal vein thrombosis (degree of vessel obstruction > 50%)
- •History of variceal hemorrhage in the past 6 weeks (recent variceal bleeding has been controlled for at least 120 hours)
排除标准
- •Uncontrolled active variceal bleeding
- •Fibrotic cord of the portal vein
- •Prior history of TIPS placement or shunt surgery or endoscopic ban ligation +NSBB
- •Concomitant renal insufficiency
- •Severe cardiopulmonary diseases
- •Uncontrolled systemic infection or sepsis
- •Malignancy or other serious medical illness which may reduce the life expectancy
- •Contraindications for propranolol, such as asthma, insulin-dependent diabetes (with episodes of hypoglycemia), and peripheral vascular disease
- •Contraindications for heparin or warfarin
- •Contraindications for TIPS
结局指标
主要结局
Number of participants with variceal rebleeding
时间窗: 4 years
Variceal rebleeding is the primary endpoint of this study. Cumulative variceal rebleeding rate is compared between the two groups.
次要结局
- Number of participants achieving portal vein recanalization(4 years)
- Number of death(4 years)
- Changes of degree of PVT in patients without portal vein recanalization(4 years)
- Number of complications(4 years)
研究者
Guohong Han
Head of Department of Digestive Interventional Radiology
Air Force Military Medical University, China