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Completed

NCT Number: NCT00357422

Comparison Study of Operation and PEIT for Small, Solitary Hepatocellular Carcinoma (HCC)

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

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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

Not applicable

Primary location

Seoul NUH

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

About this study

To compare the below things between operation group and percutaneous ethanol injection therapy (PEIT) group:

  • Survival
  • 5 year overall survival rate
  • Disease free survival rate
  • Recurrence
  • Cumulative 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 hepatitis B virus (HBV)&/or hepatitis C virus (HCV) infection or liver cirrhosis
  • Single tumor nodule with Child-Pugh classification A (serum albumin ≥ 3.2 g/dL)
  • The maximal, longest diameter of tumor mass measured by CT finding should be less than 2 cm
  • Only for the newly detected HCCs which were not treated before
  • It should be compatible with the typical finding of hepatocellular carcinomas (HCCs) radiologically (MD CT or dynamic MRI)
  • Without portal hypertension

Exclusion criteria

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

Treatment and study plan

Operation

Procedure

No drug needed

Other names: surgery

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

Prospective Randomized Trial of the Effective Therapy for Small, Solitary HCC Comparing Operation and Percutaneous Ethanol Injection Therapy

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Jul 27, 2006
Registry last updated
Sep 10, 2018

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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