Treatment of Hepatocellular Carcinoma: Long-Acting Somatostatin Plus Percutaneous Ethanol Instillation (PEI) Versus Long-Acting Somatostatin Alone
- Conditions
- Carcinoma, Hepatocellular
- Registration Number
- NCT00121914
- Lead Sponsor
- Medical University of Vienna
- Brief Summary
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.
- Detailed 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?
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- Histologically-proven hepatocellular carcinoma
- Treatable with percutaneous ethanol instillation
- Inoperable tumour
- Age 18-85 years
- Liver cirrhosis Child C
- Tumour diameter > 8 cm
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method survival time time to tumour progression
- Secondary Outcome Measures
Name Time Method quality of life causes of death
Trial Locations
- Locations (1)
Universitaetsklinik fuer Innere Medizin IV / Gastroenterologie und Hepatologie
🇦🇹Vienna, Austria