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临床试验/NCT03129685
NCT03129685Unknown不适用

Short-term Outcome of Ipsilateral Liver Lobe Devascularization of the Large Hepatocellular Carcinoma

The National Ribat University2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2017年5月20日最近更新:
适应症
干预措施

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
Short term mortality rate

研究概览

简要总结

Assessment of short-term outcomes of ipsilateral lobe arterial devascularization of the large hepatocellular carcinoma: single center non-randomized trial.

详细描述

Assessment of the 30-day mortality and major complications as well as the tumor size changes of the patients undergoing ipsilateral lobe arterial devascularization of the large hepatocellular carcinoma. This is a prospective non randomized trial carried out at the Ribat University Hospital between April 2017 to March 2018.

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 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

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

Devascularization

Experimental

Patients undergoing ipsilateral hepatic artery ligation with extrahepatic collaterals division (HALED)

干预措施: HALED (Procedure)

结局指标

主要结局

Short term mortality rate

时间窗: 30 day

Percentage of patients' postoperative deaths

次要结局

  • Tumor response rate according to mRECIST criteria.(30 days)
  • Short term major complications' rate(30 days)

研究者

发起方
The National Ribat University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Osama Mohamed Elsanousi

Associate Professor of Surgery

The National Ribat University

研究点 (2)

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