NCT00121914

Treatment of Hepatocellular Carcinoma: Long-Acting Somatostatin Plus Percutaneous Ethanol Instillation (PEI) Versus Long-Acting Somatostatin Alone

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (planned)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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?

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
PROCEDURE	percutaneous ethanol instillation (PEI)

Timeline

• Start date: 2000-10-01
• Completion: 2005-07-01
• First posted: 2005-07-21
• Last updated: 2005-10-18

Locations

1 site across 1 country: Austria