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Completed

NCT Number: NCT00357474

Comparison Study of Transarterial Chemoembolization and Percutaneous Ethanol Injection for Multiple, Small HCCs

The purpose of this study is to choose the preferred treatment modality for multiple, small hepatocellular carcinomas.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul NUH

Seoul, Chongno-gu, 110-744, South Korea

About this study

To compare the below things between PEIT group and TACE group

  • Survival
  • 5 year overall survival rate
  • Disease free survival rate
  • Recurrence a. recurrence rate

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The evidences of HBV(+) &/or HCV(+) infection or liver cirrhosis
  • Two to three tumor nodules with Child-Pugh classification A or single to three tumor nodules with Child-Pugh classification B
  • The maximal, longest diameter of tumor mass measured by CT finding should be less than 2 cm.
  • 1) Only for newly detected HCCs which were not treated before or 2) If treated before, it should be noted that there is no evidence of recurrence within the latest 6 months and, and also it should be remotely recurred more than 2cm apart from primary lesion.
  • It should be compatible with the typical findings of HCCs radiologically(MD CT or dynamic MRI)

Exclusion criteria

  • In case of hepatic vein or portal vein invasion radiologically(CT or MRI)

Treatment and study plan

Transarterial chemoembolization

Procedure

lipiodol, adriamycin and/or mitomycin

Other names: TACE

Percutaneous ethanol injection therapy

Procedure

99% ethanol 2-4cc per one session, two to three sessions per single procedure for one week

Other names: PEIT

Primary outcomes

  1. overall survival rate

    Time frame: 5 year

Secondary outcomes

  1. Disease free survival rate and recurrence rate

    Time frame: 5 year

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

A Multicenter, Randomized, Controlled Trial of the Effective Therapy for Multiple, Small Hepatocellular Carcinomas: Comparing Transarterial Chemoembolization With Percutaneous Ethanol Injection Therapy.

Important dates

Study start
2005
Primary completion
2012
Study completion
2012
First posted
Jul 27, 2006
Registry last updated
Dec 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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