Balloon Angioplasty Alone Versus in Combination With Stent Placement for the Treatment of Budd-Chiari Syndrome in China: An Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- The incidence of reocclusion between PTA alone and in combination with stent-placement groups
研究概览
简要总结
Budd-Chiari syndrome (BCS) is defined as the hepatic outflow obstruction from the small hepatic veins to the confluence between inferior vena cava and right atrium, which often leads to the life-threatening complications, such as liver failure and portal hypertension-related complications. At present, a stepwise treatment strategy is employed, including anticoagulation, thrombolysis, percutaneous recanalization (i.e., percutaneous transluminal angioplasty [PTA] alone or in combination with stent placement), transjugular intrahepatic portosystemic shunt, and liver transplantation. In West, only less than 20% of BCS patients underwent percutaneous recanalization; by contrast, percutaneous recanalization is the most common treatment modality used in China.
Recently, an 11-year retrospective case series of 177 Chinese patients with primary BCS has shown a higher rate of re-occlusion in the PTA alone group than in the PTA combined with stent placement group (31% versus 7.7%, p<0.001). In addition, re-occlusion was regarded as the independent predictor of mortality. Accordingly, we hypothesized that PTA alone might have a worse survival than PTA combined with stent placement in Chinese patients with primary BCS.
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 (Care Provider)
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
- 是
入选标准
- •Informed consent.
- •Age 18-75 years old.
- •Budd-Chiari syndrome
- •Child-Pugh score <13 points.
- •Eligible for percutaneous recanalization.
排除标准
- •Pregnancy or lactation.
- •Malignancy.
- •HIV infection.
- •Severe cardiac or lung diseases.
- •Severe renal dysfunction (serum> 265.2 umol/l).
- •Uncontrolled systemic infection.
- •Allergic to contrast agents.
- •Poor compliance.
- •A prior history of percutaneous recanalization.
- •Ineligible for percutaneous recanalization.
- •Liver cirrhosis with severe portal hypertension-related complications.
- •Acute liver failure.
- •Progressive deterioration of liver function.
研究组 & 干预措施
PTA in combination with stent-placement
In this group, the patients will undergo percutaneous balloon angioplasty with or without stent-placement angioplasty in combination with stent-placement.
干预措施: Stent (Device)
PTA in combination with stent-placement
In this group, the patients will undergo percutaneous balloon angioplasty with or without stent-placement angioplasty in combination with stent-placement.
干预措施: Balloon (Device)
PTA alone
In this group, the patients will undergo percutaneous balloon angioplasty alone. The patients will transfer to the stent placement in the following cases: 1) reocclusion with thrombosis; and 2) at least 2 reocclusion events.
干预措施: Balloon (Device)
结局指标
主要结局
The incidence of reocclusion between PTA alone and in combination with stent-placement groups
时间窗: 2 years
次要结局
- The incidence of procedure-related complications between PTA alone and in combination with stent placement groups(2 years)
- The length of hospitalization between PTA alone and in combination with stent placement groups(2 years)
- The symptom recurrence rate between PTA alone and in combination with stent placement groups(2 years)
- The survival between PTA alone and in combination with stent placement groups(2 years)
研究者
Guohong Han
Professor
Air Force Military Medical University, China