Carcinoma, Hepatocellular
Conditions
Keywords
Carcinoma, Hepatocellular,, percutaneous ethanol instillation, long-acting somatostatin
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?
Interventions
PROCEDUREpercutaneous ethanol instillation (PEI)
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| survival time | — |
| time to tumour progression | — |
Secondary
| Measure | Time frame |
|---|---|
| quality of life | — |
| causes of death | — |
Countries
Austria
Outcome results
None listed