Comparative Effectiveness of Nadroparin Versus Transjugular Intrahepatic Portosystemic Shunt in Cirrhotic Patients With Refractory Asymptomatic Portal Vein Thrombosis：a Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 主要终点
- complete recanalization rate of PVT
研究概览
简要总结
The purpose of this study is to evaluate the comparative effectiveness of nadroparin versus transjugular intrahepatic portosystemic shunt in cirrhotic patients with refractory asymptomatic portal vein thrombosis using a design of a multicenter, randomized controlled trial
详细描述
This research project aims to investigate the efficacy and safety of anticoagulant therapy in patients with portal vein thrombosis (PVT) associated with liver cirrhosis. Building upon this, a randomized controlled study will be carried out for PVT patients with poor response to anticoagulant treatment. The study will compare the effects of transjugular intrahepatic portosystemic shunt (TIPS) and prolonged anticoagulant therapy. The ultimate goal is to provide high-quality clinical research evidence for interventional treatment of liver cirrhosis-associated PVT. This comprehensive approach aims to provide evidence-based medical guidance for optimizing the treatment pathway for refractory PVT in liver cirrhosis.
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 (Outcomes Assessor)
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
- •Diagnosed with liver cirrhosis
- •Diagnosis of portal vein thrombosis through computed tomographic venography with a thrombus diameter exceeding 30% of the vessel diameter.
- •Consent to participate in the clinical trial and the signing of an informed consent form.
排除标准
- •Presence of acute symptoms such as fever, abdominal pain or bleeding, or of cavernous transformation
- •Patients with Child-Pugh C.
- •Pregnant or lactating women.
- •With a history of liver cancer or other malignancy.
- •Severe heart, lung diseases, or significant renal dysfunction.
- •Allergies to anticoagulant medications, uncontrolled hypertension, history of cerebral hemorrhage, discovery of gastrointestinal ulcers, ulcerative colitis, subacute bacterial endocarditis, or other contraindications to anticoagulant drugs.
- •On concomitant therapy of immunosuppressive drugs.
- •With coagulation disorders other than liver disease.
- •With active variceal bleeding.
研究组 & 干预措施
TIPS group
The cirrhotic patients with persistent PVT despite 6 months of anticoagulation therapy will receive transjugular-intrahepatic-portosystemic shunt.
干预措施: TIPS (Procedure)
Nadroparin group
The cirrhotic patients with persistent PVT despite 6 months of anticoagulation therapy will continue with the nadroparin therapy
干预措施: Nadroparin (Drug)
结局指标
主要结局
complete recanalization rate of PVT
时间窗: 6 months
Enhanced abdominal CT scan will be performed to assess the recanalization of PVT. The primary outcome is the complete recanalization.
次要结局
- partial recanalization rate of PVT(6 months)
- Mortality(6 months)
- Bleeding rate(6 months)