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Radiofrequency Ablation Versus Liver Resection for Elderly Patients With Hepatocellular Carcinoma (HCC) Within the Milan Criteria

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
HR
RFA
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

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. age 65 - 85 years;
  2. HCC within the Milan criteria (single HCC ≤ 5 cm or up to 3 nodules each ≤3 cm);
  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 ;

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 RFA, 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
March 28, 2012
Last Updated
March 30, 2012
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT01570075
Brief Title
Radiofrequency Ablation Versus Liver Resection for Elderly Patients With Hepatocellular Carcinoma (HCC) Within the Milan Criteria
Official Title
Radiofrequency Ablation Versus Liver Resection for Elderly Patients With Hepatocellular Carcinoma (HCC) Within the Milan Criteria
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Hepatocellular carcinoma (HCC) is a common cancer, and it is the third commonest global cause of cancer-related death. With an increase in life-expectancy of the general population, the number of elderly with HCC is expected to increase. Current curative treatment options for HCC include: liver transplantation, liver resection (LR) and local ablation therapy. Liver transplantation is a good treatment for HCC within the Milan criteria (single HCC ≤ 5 cm or up to 3 nodules each < 3 cm). As a consequence of the lack of liver donors, one relative contraindication for liver transplantation is age over 65 years, or the protocol requires elderly patients to have very good general health before they can be put on a transplant list. Transcatheter arterial chemoembolization (TACE) is used more commonly for the treatment of intermediate and advanced-staged HCC, while liver resection and local ablation therapy are used for early-staged HCC. Amongst the local ablative therapies, radiofrequency ablation (RFA) is most widely used. It has the advantage of minimally invasiveness, making it the first-line treatment for small HCC in patients with compromised liver function or associated severe medical conditions. Elderly patients are more likely to have poor general conditions and associated medical diseases. RFA has the advantage of being less invasive and it causes less pain, less blood loss and earlier recovery than LR. On the other hand, incomplete ablation of HCC and tumor track seeding may happen. Several studies have demonstrated the safety of LR for elderly patients. There is no good evidence in the medical literature to support whether RFA or LR is a better treatment for elderly patients with HCC.
Detailed Description
Hepatocellular carcinoma (HCC) is a common cancer, and it is the third commonest global cause of cancer-related death. With an increase in life-expectancy of the general population, the number of elderly with HCC is expected to increase. Current curative treatment options for HCC include: liver transplantation, liver resection (LR) and local ablation therapy. Liver transplantation is a good treatment for HCC within the Milan criteria (single HCC ≤ 5 cm or up to 3 nodules each < 3 cm). As a consequence of the lack of liver donors, one relative contraindication for liver transplantation is age over 65 years, or the protocol requires elderly patients to have very good general health before they can be put on a transplant list. Transcatheter arterial chemoembolization (TACE) is used more commonly for the treatment of intermediate and advanced-staged HCC, while liver resection and local ablation therapy are used for early-staged HCC. Amongst the local ablative therapies, radiofrequency ablation (RFA) is most widely used. It has the advantage of minimally invasiveness, making it the first-line treatment for small HCC in patients with compromised liver function or associated severe medical conditions. Elderly patients are more likely to have poor general conditions and associated medical diseases. RFA has the advantage of being less invasive and it causes less pain, less blood loss and earlier recovery than LR. On the other hand, incomplete ablation of HCC and tumor track seeding may happen. Several studies have demonstrated the safety of LR for elderly patients. There is no good evidence in the medical literature to support whether RFA or LR is a better treatment for elderly patients with HCC.

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 RFA, 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)
HR
Other Intervention Name(s)
hepatic resection; surgical 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.
Intervention Type
Procedure
Intervention Name(s)
RFA
Other Intervention Name(s)
percutaneous ablation
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.
Primary Outcome Measure Information:
Title
overall survival
Time Frame
5 year
Secondary Outcome Measure Information:
Title
disease-free survival
Time Frame
5-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 65 - 85 years; HCC within the Milan criteria (single HCC ≤ 5 cm or up to 3 nodules each ≤3 cm); 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 ; 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.
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
8620-87343117
Email
Chminsh@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
min-shan chen, M.D., Ph.D.

12. IPD Sharing Statement

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Radiofrequency Ablation Versus Liver Resection for Elderly Patients With Hepatocellular Carcinoma (HCC) Within the Milan Criteria

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