Clinical trial NCT02046356: Recurrence Risk Factors of Early-Stage Hepatocellular Carcinoma After Radio Frequency Ablation
Official title: Recurrence Risk Factors of Early-Stage Hepatocellular Carcinoma After Radio Frequency Ablation: a Multi-center Prospective Case-control Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
radiofrequency ablation
Milan Criteria
recurrence
risk factor
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
Collaborators: name: Southwest Hospital, China
First posted: 2014-01-27
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In-patients from three affiliated hospital of the Third Military Medical University

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.

Eligibility criteria: 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

Primary outcomes:
measure: Technical success
timeFrame: up to 5 years
Secondary outcomes:
measure: LTP
timeFrame: up to 5 years
measure: IDR
timeFrame: up to 5 years
measure: Overall survival
timeFrame: up to 5 years
measure: IDR-free survival
timeFrame: up to 5 years
Other outcomes:
measure: RFA complications
timeFrame: up to 5 years
Locations:
city: Chongqing
country: China
facility: Southwest hospital
state: Chongqing
Study officials:
affiliation: Southwest Hospital, China
name: Yunhua Tan
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Tan Y, Wang X, Ma K, Zhang L, Li J, Chen P, Zhang B. Risk factors for the recurrence of early hepatocellular carcinoma treated by percutaneous radiofrequency ablation with a multiple-electrode switching system: a multicenter prospective study. Int J Hyperthermia. 2022;39(1):190-199. doi: 10.1080/02656736.2021.2024279.
citation: Tan Y, Jiang J, Wang Q, Guo S, Ma K, Bie P. Radiofrequency ablation using a multiple-electrode switching system for hepatocellular carcinoma within the Milan criteria: long-term results. Int J Hyperthermia. 2018 May;34(3):298-305. doi: 10.1080/02656736.2017.1330495. Epub 2017 May 29.