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

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
RFA
hepatic resection
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, RFA, HR

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cancer Center, Sun Yat-set UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

RFA group

HR group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

disease-free survival

Full Information

First Posted
May 6, 2011
Last Updated
May 24, 2011
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT01351194
Brief Title
Radiofrequency Ablation Versus Hepatic Resection for the Treatment of Hepatocellular Carcinomas Smaller Than 2 cm
Official Title
Radiofrequency Ablation vs. Hepatic Resection for the Treatment of Hepatocellular Carcinomas Smaller Than 2 cm.A Prospective and Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
May 2012 (Anticipated)
Study Completion Date
May 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 ≤ 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Hepatocellular Carcinoma, RFA, HR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RFA group
Arm Type
Experimental
Arm Description
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.
Arm Title
HR group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
RFA
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
hepatic resection
Intervention Description
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.
Primary Outcome Measure Information:
Title
overall survival
Time Frame
3 year
Secondary Outcome Measure Information:
Title
disease-free survival
Time Frame
3 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 18 - 75 years, who refused liver transplantation; presence of solitary HCC measuring ≤ 2.0 cm in diameter; 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; Eastern Co-operative Oncology Group performance (ECOG) status 0 (15); Exclusion Criteria: severe coagulation disorders (prothrombin activity < 40% or a platelet count of < 40,000 / mm3; the presence of vascular invasion or extrahepatic spread on imaging; Child-Pugh class C liver cirrhosis or evidence of hepatic decompensation including ascites, esophageal or gastric variceal bleeding, or hepatic encephalopathy; previous treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
min-shan chen, M.D., Ph.D.
Phone
8620-87343117
Email
Chminsh@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
min-shan chen, Ph.D.,M.D.
Organizational Affiliation
Cancer Center, Sun Yat-set University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Center, Sun Yat-set University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
min-shan chen, M.D.,Ph.D.
Phone
87343117
Email
Chminsh@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
min-shan chen, M.D.,Ph.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
16495695
Citation
Chen MS, Li JQ, Zheng Y, Guo RP, Liang HH, Zhang YQ, Lin XJ, Lau WY. A prospective randomized trial comparing percutaneous local ablative therapy and partial hepatectomy for small hepatocellular carcinoma. Ann Surg. 2006 Mar;243(3):321-8. doi: 10.1097/01.sla.0000201480.65519.b8.
Results Reference
background

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

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