Treatment of Hepatocellular Carcinoma: Long-Acting Somatostatin Plus Percutaneous Ethanol Instillation (PEI) Versus Long-Acting Somatostatin Alone
This trial is active, not recruiting.
|Treatment||percutaneous ethanol instillation (pei)|
|Sponsor||Medical University of Vienna|
|Start date||October 2000|
|End date||July 2005|
|Trial size||120 participants|
|Trial identifier||NCT00121914, HCC-327-2000|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
time to tumour progression
quality of life
causes of death
Male or female participants from 18 years up to 85 years old.
Inclusion Criteria: - Histologically-proven hepatocellular carcinoma - Treatable with percutaneous ethanol instillation - Inoperable tumour - Age 18-85 years Exclusion Criteria: - Liver cirrhosis Child C - Tumour diameter > 8 cm
|Official title||Treatment of Hepatocellular Carcinoma: A Randomized Controlled Study With Long-Acting Somatostatin Plus Percutaneous Ethanol Instillation (PEI) Versus Long-Acting Somatostatin Alone|
|Principal investigator||Christian Mueller, MD|
|Description||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?|
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