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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02046356
• Other study ID #: SWH-66
• Secondary ID: SouthwestH
• Status: Active, not recruiting
• Start date: January 2014
• Est. completion date: December 2020

Study information

• Verified date: October 2020
• Source: Southwest Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 139
• Est. completion date: December 2020
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Recurrence

Intervention

Procedure:
• MESS-RFA

Locations

Country	Name	City	State
China	Southwest hospital	Chongqing	Chongqing

Sponsors (2)

Lead Sponsor	Collaborator
Yunhua Tan	Southwest Hospital, China

Country where clinical trial is conducted

China, 

References & Publications (7)

Arii S, Yamaoka Y, Futagawa S, Inoue K, Kobayashi K, Kojiro M, Makuuchi M, Nakamura Y, Okita K, Yamada R. Results of surgical and nonsurgical treatment for small-sized hepatocellular carcinomas: a retrospective and nationwide survey in Japan. The Liver Cancer Study Group of Japan. Hepatology. 2000 Dec;32(6):1224-9. — View Citation

Hasegawa K, Makuuchi M, Takayama T, Kokudo N, Arii S, Okazaki M, Okita K, Omata M, Kudo M, Kojiro M, Nakanuma Y, Takayasu K, Monden M, Matsuyama Y, Ikai I. Surgical resection vs. percutaneous ablation for hepatocellular carcinoma: a preliminary report of the Japanese nationwide survey. J Hepatol. 2008 Oct;49(4):589-94. doi: 10.1016/j.jhep.2008.05.018. Epub 2008 Jun 12. — View Citation

Kudo M. Radiofrequency ablation for hepatocellular carcinoma: updated review in 2010. Oncology. 2010 Jul;78 Suppl 1:113-24. doi: 10.1159/000315239. Epub 2010 Jul 8. Review. — View Citation

Lam VW, Ng KK, Chok KS, Cheung TT, Yuen J, Tung H, Tso WK, Fan ST, Poon RT. Risk factors and prognostic factors of local recurrence after radiofrequency ablation of hepatocellular carcinoma. J Am Coll Surg. 2008 Jul;207(1):20-9. doi: 10.1016/j.jamcollsurg.2008.01.020. Epub 2008 Apr 24. — View Citation

Lee HY, Rhim H, Lee MW, Kim YS, Choi D, Park MJ, Kim YK, Kim SH, Lim HK. Early diffuse recurrence of hepatocellular carcinoma after percutaneous radiofrequency ablation: analysis of risk factors. Eur Radiol. 2013 Jan;23(1):190-7. doi: 10.1007/s00330-012-2561-8. Epub 2012 Oct 20. — View Citation

Ng KK, Poon RT, Lo CM, Yuen J, Tso WK, Fan ST. Analysis of recurrence pattern and its influence on survival outcome after radiofrequency ablation of hepatocellular carcinoma. J Gastrointest Surg. 2008 Jan;12(1):183-91. Epub 2007 Sep 15. — View Citation

Shiina S, Tateishi R, Arano T, Uchino K, Enooku K, Nakagawa H, Asaoka Y, Sato T, Masuzaki R, Kondo Y, Goto T, Yoshida H, Omata M, Koike K. Radiofrequency ablation for hepatocellular carcinoma: 10-year outcome and prognostic factors. Am J Gastroenterol. 2012 Apr;107(4):569-77; quiz 578. doi: 10.1038/ajg.2011.425. Epub 2011 Dec 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	RFA complications	Complication rate	up to 5 years
Primary	Technical success	Complete ablation rate	up to 5 years
Secondary	LTP	local tumor progression	up to 5 years
Secondary	IDR	intrahepatic distant recurrence	up to 5 years
Secondary	Overall survival	Overall survival rates	up to 5 years
Secondary	IDR-free survival	IDR-free survival rates	up to 5 years

External Links

•   Southwest Hospital,China