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

This study is currently recruiting participants.
Verified March 2012 by Sun Yat-sen University
Sponsor:
Information provided by (Responsible Party):
Chen Min-Shan, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01570075
First received: March 28, 2012
Last updated: March 30, 2012
Last verified: March 2012

March 28, 2012
March 30, 2012
November 2011
July 2014   (final data collection date for primary outcome measure)
overall survival [ Time Frame: 5 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01570075 on ClinicalTrials.gov Archive Site
disease-free survival [ Time Frame: 5-year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Radiofrequency Ablation Versus Liver Resection for Elderly Patients With Hepatocellular Carcinoma (HCC) Within the Milan Criteria
Radiofrequency Ablation Versus Liver Resection for Elderly Patients With Hepatocellular Carcinoma (HCC) Within the Milan Criteria

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatocellular Carcinoma
  • Procedure: HR
    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.
    Other Name: hepatic resection; surgical resection
  • 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.
    Other Name: percutaneous ablation
  • Experimental: RFA group
    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.
    Intervention: Procedure: HR
  • 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.
    Intervention: Procedure: RFA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
July 2015
July 2014   (final data collection date for primary outcome measure)

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.
Both
65 Years to 85 Years
No
Not Provided
China
 
NCT01570075
HCC17
Yes
Chen Min-Shan, Sun Yat-sen University
Sun Yat-sen University
Not Provided
Not Provided
Sun Yat-sen University
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP