This trial is active, not recruiting.

Condition hepatocellular carcinoma
Sponsor Yunhua Tan
Collaborator Southwest Hospital, China
Start date January 2014
End date December 2015
Trial size 86 participants
Trial identifier NCT02046356, SWH-66, SouthwestH


The investigators aim to investigate the related risk factors and the independent risk factors of early recurrence, the rate of disease free survival and the rate of recurrence, furthermore, develop a rating system of risk factors.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
those without recurrence of Early-Stage hepatocellular carcinoma after RFA in two years
those with recurrence of Early-Stage hepatocellular carcinoma after RFA in two years

Primary Outcomes

recurrence rate
time frame: up to 2 years

Secondary Outcomes

related and independent risk factors of early recurrence
time frame: up to 2 years

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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 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

Additional Information

Official title Early Recurrence Risk Factors of Early-Stage Hepatocellular Carcinoma After Radio Frequency Ablation: a Multi-center Prospective Case-control Study
Principal investigator Yunhua Tan
Description - Radio frequency ablation (RFA), as a curable technology, has been recommended for the treatment of early hepatoma by the guidelines from different countries, however, the early (within 2 years) recurrence rate after this operation remains high, and as the investigators know the studies of the risk factors and the independent risk factor of this recurrence are only from retrospective studies, a multi-center prospective case-control study is needed. Therefore, the investigators aim to adopt this method to further identify the factor(s) from 86 patients with early hepatoma whom fulfill the diagnostic criteria of Milan and accept complete RFA during hospitalization. - After RFA, informed consents are acquired from patients and the follow-up begins. According to the follow-up data, patients are assigned to the recurrence group or the un-recurrence group. The monitoring data of the risk factors was inputted to the Epi Date software and the statistic was analyzed by SPSS 18.0. The statistical method includes: Chi-square test for the comparison of rate, Logistical regression analysis for the related risk factors and the independent risk factors.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Southwest Hospital, China.