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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-10-31

Study Completion Date

2005-07-31

Brief Summary

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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

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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

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Carcinoma, Hepatocellular

Keywords

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Carcinoma, Hepatocellular, percutaneous ethanol instillation long-acting somatostatin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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percutaneous ethanol instillation (PEI)

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Christian Mueller, MD

Role: PRINCIPAL_INVESTIGATOR

Universitaetsklinik fuer Innere Medizin IV

Locations

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Universitaetsklinik fuer Innere Medizin IV / Gastroenterologie und Hepatologie

Vienna, Vienna, Austria

Site Status

Countries

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Austria

References

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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.

Reference Type DERIVED

PMID: 19083165 (View on PubMed)

Other Identifiers

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HCC-327-2000

Identifier Type: -

Identifier Source: org_study_id