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

NCT02046356 | Unknown DMC

• 2 other identifiers: SWH-66SouthwestH
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Technical success

  Complete ablation rate

  up to 5 years

Secondary Outcomes (4)

• LTP

  up to 5 years

• IDR

  up to 5 years

• Overall survival

  up to 5 years

• IDR-free survival

  up to 5 years

Other Outcomes (1)

• RFA complications

  up to 5 years

Study Arms (1)

Early-Stage HCC

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

Procedure: MESS-RFA

Interventions

MESS-RFA PROCEDURE

Early-Stage HCC

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In-patients from three affiliated hospital of the Third Military Medical University

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yunhua Tan: lead
• Southwest Hospital, China: collaborator

Study Sites (1)

Southwest hospital

Chongqing, Chongqing Municipality, 400038, China

Location

Related Publications (9)

• 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.

  PMID: 22158026 BACKGROUND

• 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. doi: 10.1053/jhep.2000.20456.

  PMID: 11093728 BACKGROUND

• 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.

  PMID: 18620773 BACKGROUND

• 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. doi: 10.1007/s11605-007-0276-y. Epub 2007 Sep 15.

  PMID: 17874276 BACKGROUND

• 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.

  PMID: 18589357 BACKGROUND

• 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.

  PMID: 20616593 BACKGROUND

• 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.

  PMID: 23085860 BACKGROUND

• 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.

  PMID: 35042449 DERIVED

• 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.

  PMID: 28554226 DERIVED

Related Links

• Southwest Hospital,China

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Recurrence

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yunhua Tan

  Southwest Hospital, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: January 23, 2014
• First Posted: January 27, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: December 1, 2020
• Last Updated: October 26, 2020

Record last verified: 2020-10

Locations

CN (1)