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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02046356
Enrollment
139
Registered
2014-01-27
Start date
2014-01-31
Completion date
2020-12-31
Last updated
2020-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma, radiofrequency ablation, Milan Criteria, recurrence, risk factor

Brief summary

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.

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.

Interventions

PROCEDUREMESS-RFA

Sponsors

Southwest Hospital, China
CollaboratorOTHER
Yunhua Tan
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Technical successup to 5 yearsComplete ablation rate

Secondary

MeasureTime frameDescription
LTPup to 5 yearslocal tumor progression
IDRup to 5 yearsintrahepatic distant recurrence
Overall survivalup to 5 yearsOverall survival rates
IDR-free survivalup to 5 yearsIDR-free survival rates

Other

MeasureTime frameDescription
RFA complicationsup to 5 yearsComplication rate

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026