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

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: MESS-RFA

• Registration Number: NCT02046356
• Lead Sponsor: Yunhua Tan

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-23
• Study First Submitted QC: 2014-01-24
• Study First Posted: 2014-01-27
• Primary Completion: 2015-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-23
• Last Update Posted: 2020-10-26
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 139

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Early-Stage HCC	MESS-RFA	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

Primary Outcome Measures

Name	Time	Method
Technical success	up to 5 years	Complete ablation rate

Secondary Outcome Measures

Name	Time	Method
IDR	up to 5 years	intrahepatic distant recurrence
LTP	up to 5 years	local tumor progression
Overall survival	up to 5 years	Overall survival rates
IDR-free survival	up to 5 years	IDR-free survival rates

Trial Locations

Locations (1)

Southwest hospital; 🇨🇳 Chongqing, Chongqing, China