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


Phase 3
20 Years
70 Years
Not Enrolling
Both
Hepatocellular Carcinoma

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Trial Information

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


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

1. Survival

- 5 year overall survival rate

- Disease free survival rate

2. Recurrence

- Cumulative recurrence rate


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival rate

Outcome Time Frame:

5 year

Safety Issue:

Yes

Principal Investigator

J H Yoon, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Hospital

Authority:

Korea: Food and Drug Administration

Study ID:

07-2007-006

NCT ID:

NCT00357422

Start Date:

October 2005

Completion Date:

April 2013

Related Keywords:

  • Hepatocellular Carcinoma
  • HCC, operation, percutaneous ethanol injection
  • Carcinoma
  • Carcinoma, Hepatocellular

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