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

Primary Purpose

Carcinoma, Hepatocellular

Status

Unknown status

Phase

Phase 3

Locations

Austria

Study Type

Interventional

Intervention

percutaneous ethanol instillation (PEI)

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring Carcinoma, Hepatocellular,, percutaneous ethanol instillation, long-acting somatostatin

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Universitaetsklinik fuer Innere Medizin IV / Gastroenterologie und Hepatologie

Outcomes

Primary Outcome Measures

survival time

time to tumour progression

Secondary Outcome Measures

quality of life

causes of death

Full Information

NCT ID

NCT00121914

First Posted

July 15, 2005

Last Updated

October 17, 2005

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT00121914

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2005

Overall Recruitment Status

Unknown status

Study Start Date

October 2000 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Medical University of Vienna

4. Oversight

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Hepatocellular

Keywords

Carcinoma, Hepatocellular,, percutaneous ethanol instillation, long-acting somatostatin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

percutaneous ethanol instillation (PEI)

Primary Outcome Measure Information:

Title

survival time

Title

time to tumour progression

Secondary Outcome Measure Information:

Title

quality of life

Title

causes of death

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian Mueller, MD

Organizational Affiliation

Universitaetsklinik fuer Innere Medizin IV

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universitaetsklinik fuer Innere Medizin IV / Gastroenterologie und Hepatologie

City

Vienna

ZIP/Postal Code

1090

Country

Austria

12. IPD Sharing Statement

Citations:

PubMed Identifier

19083165

Citation

Muller C, Schoniger-Hekele M, Schernthaner R, Renner B, Peck-Radosavljevic M, Brichta A, Wrba F, Posch M, Bauer P, Ferenci P, Gangl A. Percutaneous ethanol instillation therapy for hepatocellular carcinoma - a randomized controlled trial. Wien Klin Wochenschr. 2008;120(19-20):608-18. doi: 10.1007/s00508-008-1086-2.

Results Reference

derived

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

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