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 because the information has not been verified recently.
Verified July 2005 by Medical University of Vienna.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00121914
First received: July 15, 2005
Last updated: October 17, 2005
Last verified: July 2005
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Medical University of Vienna

Additional 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
Study First Received: July 15, 2005
Last Updated: October 17, 2005
Health Authority: Austria: Federal Ministry for Health and Women

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

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

ClinicalTrials.gov processed this record on September 30, 2014