A Study Comparing Radiofrequency Ablation and Hepatic Resection for Hepatocellular Carcinoma

Carcinoma, Hepatocellular Clinical Trial

Official title:

A Prospective Randomized Study to Compare the Efficacy of Radiofrequency Ablation and Hepatic Resection as a Primary Treatment for Single Small Hepatocellular Carcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02482909
• Other study ID #: 0520090
• Status: Terminated
• Phase: N/A
• First received: June 20, 2015
• Last updated: June 25, 2015
• Start date: July 2005
• Est. completion date: July 2013

Study information

• Verified date: June 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this prospective randomized study is to compare the efficacy and safety of radiofrequency ablation and hepatic resection for small hepatocellular carcinomas with very homogeneous underlying conditions.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 68
• Est. completion date: July 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Age between 20 and 70 years

2. Child-Pugh class A (score 5-6)

3. Single hepatocellular carcinoma

4. Maximal diameter of the tumor from 2 to 4 cm when measured on MRI or CT (The diameter on MRI was measured prior to that on CT)

5. No previous treatment

6. Platelet count > 80,000/mm3

Exclusion Criteria:

1. HCC abutting main hepatic veins or the first branches of the main portal vein

2. HCC abutting vessels = 0.5 cm

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Procedure:
• Hepatic resection
Anatomical surgical resection of the liver including the tumor
• Radiofrequency ablation
Percutaneous ablation using radiofrequency under the imaging guidance

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	National Cancer Center, Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The patient survival		From the intervention up to 5 years or until the death of the participant whichever came first	No
Secondary	The disease-free survival		From the intervention up to 5 years or until hepatocellular carcinoma recurrence whichever came first	No