Status:

TERMINATED

"No-Touch" Radiofrequency Ablation for Small Hepatocellular Carcinoma (≤ 3cm): A Prospective Multicenter Study

Lead Sponsor:

Seoul National University Hospital

Collaborating Sponsors:

Samsung Medical Center

Chosun University Hospital

Conditions:

Radiofrequency Ablation

Microwave Ablation

Eligibility:

All Genders

20-85 years

Phase:

NA

Brief Summary

This study is a prospective multicenter study of the duration of treatment, the success rate, the frequency of complications, and the local recurrence rate of 12 months when Radio-frequency ablation t...

Detailed Description

1. Pre-treatment planning: The detailed plan of radio frequency ablation (RFA) will be implemented in accordance with the routine procedure of image evaluation prior to RFA. That is, after confirm...

Eligibility Criteria

Inclusion

  • Agree to the protocol's requirements and submit a consent form
  • 20 years old-85 years old
  • Child-Pugh Class A or B7
  • Among patients with cirrhosis, patients with hepatocellular carcinoma having a size of 1 cm-3 cm suspected of MDCT or MRI performed within 60 days are considered for radio-frequency ablation
  • Patients who do not have a history of treatment for previous hepatocellular carcinoma, or who have a history of treatment for previous hepatocellular carcinoma, if recurrence has not been confirmed for at least 2 years after treatment

Exclusion

  • the number of liver tumors is 3 or more
  • the maximum size of the tumor exceeds 3 cm
  • diffuse infiltrative type
  • the tumor adheres to the portal vein or hepatic vein or biliary tract of 5 mm or more
  • patients with previous medical history of hepatocellular cancer who have recurrent hepatocellular cancer within 2 years
  • the tumor is not visible even under CEUS-fusion image guidance
  • Child-Pugh class B8 or C
  • in case of invasion of liver vessels due to malignant hepatocellular carcinoma
  • severe coagulopathy
  • multiple distant metastasis
  • the situation where the probability of obtaining appropriate data suitable for the research purpose is very low

Key Trial Info

Start Date :

April 1 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 10 2021

Estimated Enrollment :

5 Patients enrolled

Trial Details

Trial ID

NCT04803890

Start Date

April 1 2019

End Date

March 10 2021

Last Update

March 18 2021

Active Locations (1)

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Seoul National University Hospital

Seoul, South Korea

"No-Touch" Radiofrequency Ablation for Small Hepatocellular Carcinoma (≤ 3cm): A Prospective Multicenter Study | DecenTrialz