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NCT03375281 Clinical Trial

Radiofrequency Ablation Using Octopus Electrodes for Small Hepatocellular Carcinoma With No-touch Technique

Hepatocellular Carcinoma Clinical Trial

Official title:
Radiofrequency Ablation Using Octopus Electrodes for Small Hepatocellular Carcinoma With No-touch Technique: A Prospective Single Arm Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03375281
Other study ID # SNUH-2017-0870
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 20, 2017
Est. completion date August 21, 2020

Study information
Verified date March 2021
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to evaluate clinical outcome of RFA for small single nodular HCC using no touch technique with separable clustered electrode (Octopus) in a prospective multicenter manner Participating center: Seoul national university hospital, Asan medical center, Samsung medical center, Kunkuk university hospital, St. mary's Seoul hospital

Recruitment information / eligibility
Status Completed
Enrollment 140
Est. completion date August 21, 2020
Est. primary completion date January 28, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 85 Years
Eligibility Inclusion Criteria: - Child-Pugh class A liver function - 1 - 2.5 cm sized Single nodular HCC - without history of previous HCC treatment or with evidence of no recurrence at least 2 years after previous HCC treatment Exclusion Criteria: - more than 2 HCC - tumor size larger than 2.5 cm - Child-Pugh class B or C liver function - invisible tumor even after real-time fusion US guidance - accompanied by vascular invasion or distant metastasis - presence of coagulopathy defined as platelet count < 50,000/mm3 and/or PT-INR > 50%

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• RFA
thermal ablation using radiofrequency for HCC

Locations
Country Name City State
Korea, Republic of Asan medical Center Seoul
Korea, Republic of KonKuk university hospital Seoul
Korea, Republic of Saint Mary Hospital Seoul
Korea, Republic of Samsung medical center Seoul
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (2)
Lead Sponsor Collaborator
Seoul National University Hospital starmed

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 1 year local tumor progression cumulative incidence of local tumor progression after RFA 1 year after procedure
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