Ignite Creation Date:
2024-05-05 @ 11:31 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01351194
Status:
UNKNOWN
Last Update Posted:
2011-05-26
First Post:
2011-05-06
Brief Title:
Radiofrequency Ablation Versus Hepatic Resection for the Treatment of Hepatocellular Carcinomas Smaller Than 2 cm
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Radiofrequency Ablation vs Hepatic Resection for the Treatment of Hepatocellular Carcinomas Smaller Than 2 cmA Prospective and Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2010-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 20 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 20 cm in diameter who underwent PRFA or HR
Detailed 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 20 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 20 cm in diameter who underwent PRFA or HR
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 20 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 20 cm in diameter who underwent PRFA or HR
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None