Long Term Outcome of Combined Ipsilateral Liver Lobe Devascularization and Alcohol Treatment (CILDAT) of the Large Hepatocellular Carcinoma (HCC)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Overall survival rate
研究概览
简要总结
Assessment of the long-term outcome of combined ipsilateral liver lobe devascularization (ILAD) and alcohol injection of the large hepatocellular carcinoma (HCC): single center non-randomized trial.
详细描述
Assessment of the overall (OS); one year; two years and three years' survival rates; the disease free survival (DFS) and the tumor response rate in the patients undergoing Combined Ipsilateral Liver Lobe Devascularization and Alcohol Treatment (CILDAT) of the Large HCC. This is a prospective non randomized trial carried out at the Ribat University Hospital between May 2017 to April 2020.
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
- 15 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Review and sign informed consent;
- •Between 15 and 80 years of age at time of trial enrollment;
- •Documented pathological and/or radiological diagnosis of hepatocellular carcinoma;
- •Radiologically documented tumor size of > 5 centimeters;
- •Radiologically documented liver cirrhosis.
排除标准
- •American Anesthesia Association (ASA) Class IV or V and/or any contraindications to general anesthesia;
- •Uncontrollable ascites;
- •Deep persistent jaundice;
- •Hepatic encephalopathy;
- •Coagulopathy;
- •Severe uncorrectable thrombocytopenia;
- •Unable or unwilling to attend follow up visits and examinations;
研究组 & 干预措施
Combined Treatment
The Combined Treatment: patients undergo a surgical operation of ipsilateral liver lobe devascularization and four weeks later after the operation percutaneous alcohol injection sessions.
干预措施: Combined Treatment (Procedure)
结局指标
主要结局
Overall survival rate
时间窗: 3 years
The percentage of patients who are still alive for three years after they started CILDAT for their large HCC.
次要结局
- Major toxicity rate(3 years)
- Disease free survival(3 years)
- Major complications' rate(3 years)
- Tumor response rate(3 years)
研究者
Osama Mohamed Elsanousi
General Surgeon
The National Ribat University