Treatment of Hepatocellular Carcinoma: Long-Acting Somatostatin Plus Percutaneous Ethanol Instillation (PEI) Versus Long-Acting Somatostatin Alone
Recruitment status was Active, not recruiting
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.
Procedure: percutaneous ethanol instillation (PEI)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Hepatocellular Carcinoma: A Randomized Controlled Study With Long-Acting Somatostatin Plus Percutaneous Ethanol Instillation (PEI) Versus Long-Acting Somatostatin Alone|
- survival time
- time to tumour progression
- quality of life
- causes of death
|Study Start Date:||October 2000|
|Estimated Study Completion Date:||July 2005|
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?
Please refer to this study by its ClinicalTrials.gov identifier: NCT00121914
|Universitaetsklinik fuer Innere Medizin IV / Gastroenterologie und Hepatologie|
|Vienna, Austria, 1090|
|Principal Investigator:||Christian Mueller, MD||Universitaetsklinik fuer Innere Medizin IV|