Radiofrequency Ablation Versus Hepatic Resection for the Treatment of Hepatocellular Carcinomas Smaller Than 2 cm

Hepatocellular Carcinoma Clinical Trial

Official title: Radiofrequency Ablation vs. Hepatic Resection for the Treatment of Hepatocellular Carcinomas Smaller Than 2 cm.A Prospective and Randomized Clinical Trial

Status Recruiting

Clinical Trial Summary

Recently, a clinical trial has shown that PRFA is as effective as HR for small HCC in terms of overall survival and disease-free survival. This has prompted some authors to suggest that PRFA could be more suitable than HR for early stage HCC. Some authors also have suggested that PRFA can be considered the treatment of choice for patients with single HCC ≤ 2.0 cm, even when HR is possible. On the other hand, some tumors (subcapsular location, adjacent to intestinal loops or main bile ducts) may be unsuitable for PRFA because of the risk of bleeding, tumor seeding, bile leakage, perforation, and so on. Furthermore, in our previous experience, some tumors (with deep locations, which were included as "central HCC") may be also unsuitable for HR because of risks of more injury of normal liver tissue, blood loss after resection, and so on. Therefore, the appropriate therapeutic option for these HCC tumors ≤ 2 cm, especially for central HCC, is still under debate. To clarify this issue, the investigators conducted a study that included a consecutive series of patients with single resectable HCC < 2.0 cm in diameter, who underwent PRFA or HR.

Clinical Trial Description

With the development of medical science, more and more patients are being diagnosed with hepatocellular carcinoma (HCC) at an early stage (single ≤ 5 cm in diameter or ≤ 3 nodules, ≤ 3 cm in diameter) allowing for radical treatment by hepatic resection (HR), liver transplantation, or percutaneous ablation . Liver transplantation can eliminate the tumor and cirrhosis at the same time, and is considered to be the most appropriate treatment for these patients. However, the lack of liver donors is a major limitation. Until now, HR has still been considered as the first-choice treatment for these patients, which may offer a 5-year survival rate above 50%. Percutaneous ablation, including percutaneous ethanol injection (PEI) and percutaneous radiofrequency ablation (PRFA), is usually considered to be a second-choice treatment for small HCC which is unresectable due to impaired liver function, and liver transplantation is not indicated.

Recently, a clinical trial has shown that PRFA is as effective as HR for small HCC in terms of overall survival and disease-free survival. This has prompted some authors to suggest that PRFA could be more suitable than HR for early stage HCC. Some authors also have suggested that PRFA can be considered the treatment of choice for patients with single HCC ≤ 2.0 cm, even when HR is possible. On the other hand, some tumors (subcapsular location, adjacent to intestinal loops or main bile ducts) may be unsuitable for PRFA because of the risk of bleeding, tumor seeding, bile leakage, perforation, and so on. Furthermore, in our previous experience, some tumors (with deep locations, which were included as "central HCC") may be also unsuitable for HR because of risks of more injury of normal liver tissue, blood loss after resection, and so on. Therefore, the appropriate therapeutic option for these HCC tumors ≤ 2 cm, especially for central HCC, is still under debate. To clarify this issue, the investigators conducted a study that included a consecutive series of patients with single resectable HCC < 2.0 cm in diameter, who underwent PRFA or HR. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

• NCT number: NCT01351194
• Study type: Interventional
• Source: Sun Yat-sen University
• Contact: min-shan chen, M.D., Ph.D.
• Phone: 8620-87343117
• Email: Chminsh@mail.sysu.edu.cn
• Status: Recruiting
• Phase: Phase 4
• Start date: March 2010
• Completion date: May 2013