Recurrence Risk Factors of Early-Stage Hepatocellular Carcinoma After Radio Frequency Ablation

October 23, 2020 updated by: Yunhua Tan

Recurrence Risk Factors of Early-Stage Hepatocellular Carcinoma After Radio Frequency Ablation: a Multi-center Prospective Case-control Study

The aim was to investigate the efficacy of radiofrequency ablation (RFA) with a multiple-electrode switching system (MESS) in the treatment of early hepatocellular carcinoma (HCC) and to evaluate the patterns and risk factors of intrahepatic recurrence of HCC after RFA.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Percutaneous RFA has become a particularly promising treatment for patients with early HCC. For HCC with a diameter less than 3cm, RFA is becoming an effective topical method for the goal of a complete cure. Although RFA is successful for small HCCs, for HCCs with a diameter larger than 3 to 5 cm, the complete ablation rate is reported to range from 61.3% to 82.5%. These results may be obsolete due to the further development of RFA techniques and instruments. For example, the use of clustered electrodes and an improved motor can provide a higher power, and the multiple-electrode switching system RFA (MESS-RFA) uses various methods to create a sufficient ablation zone, the investigators need to further update the management strategy of the RFA treatment of early HCC.

However, HCC recurrence after RFA is still a significant problem . the investigators divide the intrahepatic recurrence after RFA into local tumor progression (LTP) and intrahepatic distant recurrence (IDR); each type of recurrence has a different pathogenic mechanism and is thought to occur relatively independently . Understanding the pattern and risk factors of recurrence is very important for the development of RFA and its clinical application.

The objective of our multicenter prospective study was to evaluate the efficacy of MESS-RFA as a primary method for treating early HCC, to assess the pattern of intrahepatic recurrence according to the types of recurrence, and to determine the risk factors associated with tumor recurrence and survival.

Study Type

Observational

Enrollment (Actual)

139

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400038
        • Southwest Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

In-patients from three affiliated hospital of the Third Military Medical University

Description

Inclusion Criteria:

  • 18-70 years old
  • The diameter of single tumor should be no more than 5cm, or multiple tumors(less than 3 loci) should be no more than 3cm. No large vascular invasion, no lymph nodes or extrahepatic metastases
  • The Classification of patients' liver function is Child - Pugh A or B
  • No serious coagulation dysfunction (prothrombin activity < 40% or platelet count < 30000 / mL).
  • No refractory ascites.
  • The patients can be treated with RFA in clinical
  • Primary treatment by RFA should ablate the tumor(s) completely
  • The patients are aware of their condition, the treatment of the HCC, and the risks associated with radiofrequency ablation therapy.
  • The patients participant voluntarily and they will sign the informed consent before the radiofrequency ablation therapy.

Exclusion Criteria:

  • The patients are from abroad, Hong Kong, Macao, Taiwan and other regions, who are impossible to be follow-up
  • The patients who refuse to sign the informed consent
  • Tumor emboli existed in main portal vein, ductus hepatics communis and(or) its primary branch, main hepatic vein and(or) inferior vena cava before operation
  • Extrahepatic metastasis, lymph node metastasis
  • The patients whom accept systemic chemotherapy, preoperative interventional therapy, and(or) other auxiliary treatment
  • The patients with diabetes mellitus, heart disease and(or) other diseases can't tolerate radiofrequency ablation, or influence postoperative follow-up
  • The existence of other type of malignant tumor before or accompanied by HCC
  • Primary treatment by RFA do not ablate the tumor(s) completely
  • Non-primary liver tumor, such as the liver metastatic carcinoma, cholangiocarcinoma, etc

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Early-Stage HCC
Early-Stage hepatocellular carcinoma From January 2014 to January 2015, a total of 139 patients with early HCC from the First Affiliated Hospital, the Second Affiliated Hospital and the Third Affiliated Hospital of the Third Military Medical University were prospectively recruited according after MESS-RFA
Procedure: MESS-RFA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success
Time Frame: up to 5 years
Complete ablation rate
up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LTP
Time Frame: up to 5 years
local tumor progression
up to 5 years
IDR
Time Frame: up to 5 years
intrahepatic distant recurrence
up to 5 years
Overall survival
Time Frame: up to 5 years
Overall survival rates
up to 5 years
IDR-free survival
Time Frame: up to 5 years
IDR-free survival rates
up to 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
RFA complications
Time Frame: up to 5 years
Complication rate
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yunhua Tan

Collaborators

Southwest Hospital, China

Investigators

  • Principal Investigator: Yunhua Tan, Southwest Hospital, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

January 23, 2014

First Submitted That Met QC Criteria

January 24, 2014

First Posted (Estimate)

January 27, 2014

Study Record Updates

Last Update Posted (Actual)

October 26, 2020

Last Update Submitted That Met QC Criteria

October 23, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SWH-66
  • SouthwestH (Other Identifier: SouthwestH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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