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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Sun Yat-sen University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01351194
First received: May 6, 2011
Last updated: May 24, 2011
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Hepatocellular Carcinoma
Procedure: RFA
Procedure: hepatic resection
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Radiofrequency Ablation vs. Hepatic Resection for the Treatment of Hepatocellular Carcinomas Smaller Than 2 cm.A Prospective and Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • overall survival [ Time Frame: 3 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • disease-free survival [ Time Frame: 3 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: March 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RFA group
For PRFA, we used a commercially available system with a 375-KHz computer-assisted radiofrequency generator (Elektrotom HiTT 106, Berchtold, Medizinelektronik, Germany) and an open-perfused electrode (Berchtold, Tuttlingen, Germany) of 15 cm (or 20 cm), 14 Ga, and a 15 mm (or 20 mm) active electrode tip with microbores.
Procedure: RFA
For PRFA, we used a commercially available system with a 375-KHz computer-assisted radiofrequency generator (Elektrotom HiTT 106, Berchtold, Medizinelektronik, Germany) and an open-perfused electrode (Berchtold, Tuttlingen, Germany) of 15 cm (or 20 cm), 14 Ga, and a 15 mm (or 20 mm) active electrode tip with microbores. The 14 Ga needle was introduced into the center of the tumor; then, 60 W of the radiofrequency energy was delivered by the generator with an 8-minute duration for every single energy application.
Experimental: HR group
SR was carried out under general anesthesia using a right subcostal incision with a midline extension. Intra-operative ultrasonography was performed routinely to evaluate the tumor burden, liver remnant, and the possibility of a negative resection margin. Anatomic resection, in the form of segmentectomy and/or subsegmentectomy as described by Makuuchi et al. (16) was the preferred surgical method of liver resection. Pringle's maneuver was routinely used with a clamp and unclamp time of 10 min and 5 min, respectively; this technique was used repeatedly throughout the entire procedure.
Procedure: hepatic resection
SR was carried out under general anesthesia using a right subcostal incision with a midline extension.Intra-operative ultrasonography was performed routinely to evaluate the tumor burden, liver remnant, and the possibility of a negative resection margin. Anatomic resection, in the form of segmentectomy and/or subsegmentectomy as described by Makuuchi et al. (16) was the preferred surgical method of liver resection. Pringle's maneuver was routinely used with a clamp and unclamp time of 10 min and 5 min, respectively; this technique was used repeatedly throughout the entire procedure. Hemostasis of the raw liver surface was done with suturing and application of fibrin glue.

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 ≤ 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age 18 - 75 years, who refused liver transplantation;
  2. presence of solitary HCC measuring ≤ 2.0 cm in diameter;
  3. resectable disease, which is defined as the possibility of completely removing all tumors and retaining a sufficient liver remnant to maintain liver function, as assessed by our surgery team;
  4. Eastern Co-operative Oncology Group performance (ECOG) status 0 (15);

Exclusion Criteria:

  1. severe coagulation disorders (prothrombin activity < 40% or a platelet count of < 40,000 / mm3;
  2. the presence of vascular invasion or extrahepatic spread on imaging;
  3. Child-Pugh class C liver cirrhosis or evidence of hepatic decompensation including ascites, esophageal or gastric variceal bleeding, or hepatic encephalopathy;
  4. previous treatment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01351194

Contacts
Contact: min-shan chen, M.D., Ph.D. 8620-87343117 Chminsh@mail.sysu.edu.cn

Locations
China, Guangdong
Cancer Center, Sun Yat-set University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: min-shan chen, M.D.,Ph.D.    87343117    Chminsh@mail.sysu.edu.cn   
Principal Investigator: min-shan chen, M.D.,Ph.D.         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: min-shan chen, Ph.D.,M.D. Cancer Center, Sun Yat-set University
  More Information

Publications:
Responsible Party: Cancer Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01351194     History of Changes
Other Study ID Numbers: HCC0012
Study First Received: May 6, 2011
Last Updated: May 24, 2011
Health Authority: China: Ministry of Health

Keywords provided by Sun Yat-sen University:
Hepatocellular Carcinoma
RFA
HR

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on July 29, 2014