Outcome of Percutaneous Ethanol Alcohol Injection (PEI) for the Large and Unresectable Hepatocellular Carcinoma.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Overall survival rate
研究概览
简要总结
Assessment of the long-term outcome of percutaneous ethanol alcohol injection (PEI) for the large and unresectable hepatocellular carcinoma: 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 (PAT or PEI) for the large and inoperable hepatocellular carcinoma. 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
盲法说明
No masking
入排标准
- 年龄范围
- 15 Years 至 80 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 thrombocytopenia;
- •Unable or unwilling to attend follow up visits and examinations;
- •Other associated surgical procedure;
研究组 & 干预措施
Percutaneous Ethanol Injection (PEI)
Those participants receive percutaneous ethanol alcohol injection for the large and unresectable HCC. Absolute alcohol; weekly sessions; under close monitoring; maximum of 30 mls; no anaesthesia needed and a maximum pain score of "8" during the procedure. Postprocedure analgesia may be required.
干预措施: Percutaneous ethanol alcohol injection (Procedure)
结局指标
主要结局
Overall survival rate
时间窗: 3 years
The percentage of HCC patients who are still alive for three years after they started PEI for HCC.
次要结局
- Disease free survival(3 years)
- Tumor response rate(3 years)
- Major complications' rate(3 years)
研究者
Osama Mohamed Elsanousi
General Surgeon
The National Ribat University