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临床试验/NCT00121914
NCT00121914Unknown3 期

Treatment of Hepatocellular Carcinoma: A Randomized Controlled Study With Long-Acting Somatostatin Plus Percutaneous Ethanol Instillation (PEI) Versus Long-Acting Somatostatin Alone

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2000年10月最近更新:
适应症

试验速览

阶段
3 期
入组人数
120
试验地点
2
主要终点
survival time

研究概览

简要总结

Hepatocellular carcinoma (HCC) is a consequence of liver cirrhosis. In early tumour stages, tumour resection or liver transplantation are therapeutic options; later tumour stages may be treated with locally ablative treatments such as percutaneous ethanol instillation (PEI), transarterial chemoembolization (TACE) or radio-frequency thermoablation. This randomized study investigates the effect of PEI on survival of patients with HCC. All patients will receive hormonal treatment (long-acting somatostatin intramuscularly [i.m.]) and will be randomized for treatment with PEI or no additional treatment.

详细描述

This is a randomized two-arm parallel group study.

  • Study group: PEI + long-acting somatostatin
  • Control group: long-acting somatostatin alone

Aims of the study:

  • Does treatment with PEI+ long-acting somatostatin prolong survival as compared to treatment with long-acting somatostatin alone?
  • Can time to tumour progression be extended in patients treated with PEI + long-acting somatostatin as compared to treatment with long-acting somatostatin alone?

研究设计

研究类型
Interventional
分配方式
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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Histologically-proven hepatocellular carcinoma
  • Treatable with percutaneous ethanol instillation
  • Inoperable tumour
  • Age 18-85 years

排除标准

  • Liver cirrhosis Child C
  • Tumour diameter > 8 cm

结局指标

主要结局

survival time

time to tumour progression

次要结局

  • quality of life
  • causes of death

研究者

申办方类型
Other

研究点 (2)

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