NCT01471080已完成不适用
A Prospective Controlled Study on Treatment of Giant Cavernous Hemangiomas of the Liver：RFA Versus Laparoscopic Hepatectomy.
Southwest Hospital, China1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2011年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- disappearance rate of disease
研究概览
简要总结
In the past, the investigators often treated giant cavernous hemangiomas of the liver by hepatectomy.Recently RFA and laparoscopic hepatectomy are also available and could be applied to cure this disease.But we can't get a clear answer about their effectiveness and safety. Hence the investigators conduct this study to explore the effectiveness and efficiency of the these two methods and compare their short to mid-term outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •giant cavernous hemangiomas with a diameter larger than or equal to 5 cm diagnosed by more than one imaging modalities
- •age between 18 years to 65 years
- •without gender restriction
- •PLT account more than 50 e9
- •without abnormal of liver function test
- •with substantial evidence of growing size than before
- •symptom associated cavernous hemangiomas
- •with a strong desire of the patients for the treatment
排除标准
- •pregnant women
- •abnormal of liver function or coagulation dysfunction and/or concurrent with sever cardiac or pulmonary disorders
- •patient with a poor condition that can't bear the approach of either RFA or laparoscopic hepatectomy
- •tumor size more than 20cm
结局指标
主要结局
disappearance rate of disease
时间窗: 1 month
to determine the disappearance rate of disease by imaging modality using enhanced Ultrasound examine and/or enhanced CT
次要结局
- complication rate(1 month)
- hospital stay and relating overall cost for treatment(1 month)
研究者
feng xiaobin
Institute of hepatobiliary surgery,southwest hospital
Southwest Hospital, China
研究点 (1)
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