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Radiofrequency Ablation With Gradual Radiofrequency Energy Increment for Hepatocellular Carcinoma Treatment

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Seoul National University

Status

Enrolling

Conditions

Chronic Liver Disease
Liver Cirrhosis
Hepatocellular Carcinoma

Treatments

Procedure: Radiofrequency ablation using gradual radiofrequency energy delivery with Octopus electrodes

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05397860
1909-086-1064

Details and patient eligibility

About

To evaluate local tumor progression rate at 12 months after percutaneous radiofrequency ablation with gradual radiofrequency energy delivery mode with Octopus electrodes in patients with hepatocellular carcinoma.

Enrollment

120 estimated patients

Sex

All

Ages

20 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Child-Pugh Class A or B
  • chronic hepatitis B or liver cirrhosis
  • contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) within 60 days of scheduled radiofrequency ablation (RFA) date
  • clinically diagnosed hepatocellular carcinoma (HCC), equal or less than 4 cm

Exclusion criteria

  • number of HCC, equal or more than 3
  • largest tumor size over 4 cm
  • Child-Pugh class C
  • presence of vascular invasion by HCC
  • platelet count less than 40,000 per mm3 or International Normalized Ratio (INR) prolongation over 50%
  • presence of extrahepatic metastasis

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

120 participants in 1 patient group

Patients with clinically diagnosed hepatocellular carcinoma (HCC) (equal or less than 4 cm )
Experimental group
Description:
Patients with chronic hepatitis B or liver cirrhosis have hepatocellular carcinoma (HCC) (equal or less than 4 cm) which is diagnosed on contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI).
Treatment:
Procedure: Radiofrequency ablation using gradual radiofrequency energy delivery with Octopus electrodes

Trial contacts and locations

1

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Central trial contact

Jae Hyun Kim, M.D.; Hyun Hee Lee

Data sourced from clinicaltrials.gov

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