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

Medical University of Vienna

Status and phase: Unknown; Phase 3

Conditions: Carcinoma, Hepatocellular

Treatments: Procedure: percutaneous ethanol instillation (PEI)

Study type: Interventional

Funder types: Other

Identifiers

NCT00121914

HCC-327-2000

Details and patient eligibility

About

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.

Full 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?

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)