Efficacy of Apixaban in Treating Portal Vein Thrombosis Occurring More Than One Year After Laparoscopic Splenectomy and Azygoportal Disconnection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Proportion of participants with Main and Intrahepatic Branches of Portal Vein Thrombosis
研究概览
简要总结
The purpose of this study is to determine whether Apixaban is effective and safe in the treatment of portal vein thrombosis at one year and long-term follow-up in liver cirrhotic patients after laparoscopic splenectomy and azygoportal disconnection.
详细描述
After successful screening, liver cirrhotic patients of any etiology without portal vein thrombosis will be enrolled. From postoperative day 1, patients in the apixaban group will receive oral apixaban 2.5 mg twice daily for six months as monotherapy. Doppler ultrasound screening for portal vein thrombosis (PVT) or spleno-mesenteric thrombosis will be performed for all patients at baseline, on postoperative day 7 (POD 7), and at postoperative months 1, 3, 6, 12, 18, 24, and 36 (POM 1, 3, 6, 12, 18, 24, 36). All patients will complete the six-month prophylactic therapy regardless of Doppler findings regarding PVT occurrence. After the six-month treatment period, patients will be evaluated and will discontinue therapy to enter the monitoring phase. Long-term follow-up will continue up to 36 months to evaluate the primary outcome of PVT treatment effect and secondary outcomes including portal hypertension progression, rebleeding rates, hepatic encephalopathy, and survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical, radiological, or histologic diagnosis of cirrhosis of any etiology.
- •Splenomegaly with secondary hypersplenism.
- •Bleeding portal hypertension.
- •No evidence of portal vein thrombosis (PVT) or spleno-mesenteric thrombosis by ultrasound evaluation and angio-CT prior to surgery.
- •Underwent laparoscopic splenectomy and azygoportal disconnection (LSD) at our center.
- •Received routine aspirin anticoagulation (2.5 mg twice daily) immediately after surgery.
- •Had no imaging evidence (Doppler ultrasound or CT) of PVT during postoperative months 6 to
- •Developed de novo PVT after 12 months post-surgery.
- •Provided informed consent to participate in the study.
排除标准
- •Hepatocellular carcinoma or any other malignancy,
- •Hypercoagulable state other than the liver disease related
- •DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs.
- •Child - Pugh C
- •Recent peptic ulcer disease
- •History of Hemorrhagic stroke
- •Uncontrolled Hypertension
- •Human immunodeficiency virus (HIV) infection
研究组 & 干预措施
Apixaban group
From postoperative day 1, patients will receive oral apixaban tablets (Bristol-Myers Squibb, Cruiserath, USA) 2.5 mg twice daily until month 6. Doppler ultrasound screening will be performed to assess the occurrence of portal vein thrombus.
干预措施: Apixaban 2.5 MG (Drug)
结局指标
主要结局
Proportion of participants with Main and Intrahepatic Branches of Portal Vein Thrombosis
时间窗: Follow-up of 12 months or greater
Proportion of participants with thrombosis involving the main portal vein and intrahepatic branches, as determined by Doppler ultrasound imaging.
Complete resolution of portal vein thrombosis as assessed by Doppler ultrasound after re-anticoagulation
时间窗: Follow-up of 12 months or greater
Complete resolution of portal vein thrombosis in patients with PVT detected at one-year follow-up post-discontinuation, as confirmed by Doppler ultrasound after re-anticoagulation.
次要结局
- Proportion of participants with splenic vein thrombosis as assessed by Doppler ultrasound(12 months)
- Proportion of participants with mesenteric vein thrombosis as assessed by Doppler ultrasound(12 months)
研究者
Guo-Qing Jiang
Clinical Professor
Northern Jiangsu People's Hospital