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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2005 by Medical University of Vienna.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00121914
First Posted: July 21, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medical University of Vienna
  Purpose
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.

Condition Intervention Phase
Carcinoma, Hepatocellular Procedure: percutaneous ethanol instillation (PEI) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Hepatocellular Carcinoma: A Randomized Controlled Study With Long-Acting Somatostatin Plus Percutaneous Ethanol Instillation (PEI) Versus Long-Acting Somatostatin Alone

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • survival time
  • time to tumour progression

Secondary Outcome Measures:
  • quality of life
  • causes of death

Estimated Enrollment: 120
Study Start Date: October 2000
Estimated Study Completion Date: July 2005
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?
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00121914


Locations
Austria
Universitaetsklinik fuer Innere Medizin IV / Gastroenterologie und Hepatologie
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Christian Mueller, MD Universitaetsklinik fuer Innere Medizin IV
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00121914     History of Changes
Other Study ID Numbers: HCC-327-2000
First Submitted: July 15, 2005
First Posted: July 21, 2005
Last Update Posted: December 9, 2005
Last Verified: July 2005

Keywords provided by Medical University of Vienna:
Carcinoma, Hepatocellular,
percutaneous ethanol instillation
long-acting somatostatin

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Ethanol
Somatostatin
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists