Role of (LMWH) in Prevention of Thromboembolic Complication After (TACE) in Hepatocellular Carcinoma.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of patients with portal vein thrombosis
研究概览
简要总结
Hepatocellular carcinoma (HCC) is a major health problem worldwide, and most cases are inoperable because of late presentation and underlying cirrhosis. It represents the fifth most common tumor in the world and the third most frequent cause of mortality amongst patients with cancer.
Due to the worldwide difficulties in finding liver for transplantation, hepatic resection (HR) represents the main stay of curative treatment for patients with HCC. Transcatheter arterial chemoembolization (TACE) is widely used as alternative treatments for unresectable HCC or for patients not eligible to be operated on .
TACE also could be an adjuvant therapy for resectable HCC patients after hepatectomy, which could prevent recurrence and improve long-term survival .
详细描述
Thromboembolism is a well-recognised complication of malignant disease. Clinical manifestations vary from venous thromboembolism to disseminated intravascular coagulation and arterial embolism. Disseminated intravascular coagulation is most commonly observed in patients with haematological malignant disorders and those with wide spread metastatic cancer, whereas arterial embolism is most commonly observed in patients undergoing chemotherapy and in those with non-bacterial thrombotic endocarditis .
The goals of using antithrombotic therapy with TACE in HCC are to minimize mortality and to improve survival rate without provoking excessive bleeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCC which was not amenable to surgical resection, liver transplantation or local ablative therapy.
- •The lesion had not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
- •Reasonable performance status as adequate hematologic function; adequate hepatic function and adequate renal function.
- •Child-Pugh class A or B and no portal vein thrombosis.
排除标准
- •Child C patients Portal vein thrombosis
研究组 & 干预措施
TACE and LMWH
2nd group: included 20 patients with HCC treated by TACE and adjuvant dose of Low Molecular Weight Heparins (LMWH).
干预措施: TACE (Procedure)
Transarterial Chemoembolization
1st group: included 20 patients with HCC treated by TACE only.
干预措施: TACE (Procedure)
TACE and LMWH
2nd group: included 20 patients with HCC treated by TACE and adjuvant dose of Low Molecular Weight Heparins (LMWH).
干预措施: LMWH (Drug)
结局指标
主要结局
Number of patients with portal vein thrombosis
时间窗: 3 months
次要结局
未报告次要终点
研究者
Sherief Abd-Elsalam
MD liver diseases
Tanta University