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Radiofrequency Versus Laser Ablation for Hepatocellular Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Giovan Giuseppe Di Costanzo, Cardarelli Hospital
ClinicalTrials.gov Identifier:
NCT01096914
First received: March 30, 2010
Last updated: January 28, 2014
Last verified: January 2014

March 30, 2010
January 28, 2014
January 2009
September 2012   (final data collection date for primary outcome measure)
Tumor response [ Time Frame: four weeks after treatment ] [ Designated as safety issue: No ]
Complete ablation of the HCC nodule, defined as absence of contrast enhancement of the nodule at CT or MRI imaging
Same as current
Complete list of historical versions of study NCT01096914 on ClinicalTrials.gov Archive Site
  • overall survival [ Time Frame: 12 months after last treatment ] [ Designated as safety issue: No ]
    Time from randomization to death. Patients alive at the end of follow-up are censored.
  • time to local recurrence [ Time Frame: 12 months after treatment ] [ Designated as safety issue: No ]
    the time from complete tumor ablation to reappearance of arterial enhancement on CT or MRI either within a treated tumor or near its borders
  • time to progression [ Time Frame: 12 months after treatment ] [ Designated as safety issue: No ]
    Time from randomization to radiological progression. Definition of progression is based on the RECIST amendments. Deaths during follow-up without evidence of radiological progression are censored.
  • overall survival [ Time Frame: 12 months after last treatment ] [ Designated as safety issue: No ]
    Time from randomization to death. Patients alive at the end of follow-up are censored.
Not Provided
Not Provided
 
Radiofrequency Versus Laser Ablation for Hepatocellular Carcinoma
Radiofrequency Ablation Versus Laser Ablation for the Treatment of Small Hepatocellular Carcinoma: a Randomized Controlled Trial

The purpose of this study is to prospectively compare percutaneous radiofrequency ablation (RFA) versus percutaneous laser ablation (LA) for the treatment of small hepatocellular carcinoma in patients with cirrhosis.

Percutaneous ablation is a safe and effective therapy for cirrhotic patients with HCC when resection or liver transplantation is not possible. Among the various percutaneous local ablative therapies, radiofrequency ablation (RFA) has attracted the greatest interest because of its effectiveness and safety for single HCC ≤ 5.0cm or ≤3 HCC nodules ≤3cm. Some studies have shown that laser ablation (LA) may be as effective as RFA in the treatment of HCC. However, RFA and LA are different techniques and, in different cases (for example: size or site of HCC nodule), each of these procedures may have some advantages or disadvantages. Therefore there is the need for a prospective randomized controlled study to compare RFA and LA in patients with small HCC.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Carcinoma, Hepatocellular
  • Neoplasms, Liver
  • Procedure: percutaneous radiofrequency ablation
    Procedure: Radiofrequency ablation For RFA, we used a commercially available system (Valleylab, Tyco Healthcare, Boulder, CO, USA) and a 17-gauge "cool-tip" needle electrode with a 3cm exposed tip. The needle is inserted percutaneously under ultrasound guidance in the HCC nodule and treatment lasts 12 minutes. For nodules larger than 3cm in diameter, 2 insertions are used. In a period of six months, treatment may be repeated for no more than three times. When, after treatment, CT or MRI show a residual nodule activity of 10% or less, percutaneous ethanol injection may be done. If the residual activity is of 50% or more transarterial chemoembolization may be used.
    Other Name: Cool-tip ablation system - Valleylab, USA
  • Procedure: percutaneous laser ablation
    Procedure: Laser ablation For LA, we used a commercially available system (Echolaser XVG system, Esaote El.En., Florence, Italy) and four optical fibers,inserted into the cancer through four 21-gauge needles. The treatment lasts 6 minutes. For nodules larger than 3 cm in diameter, two treatments are done. In a period of six months, treatment may be repeated for no more than three times. When, after treatment, CT or MRI show a residual nodule activity of 10% or less, percutaneous ethanol injection may be done. If the residual activity is of 50% or more transarterial chemoembolization may be used.
    Other Name: Echolaser XVG system, Italy
  • Active Comparator: Radiofrequency
    patients treated with percutaneous radiofrequency ablation
    Intervention: Procedure: percutaneous radiofrequency ablation
  • Active Comparator: laser
    Patients treated with percutaneous laser ablation
    Intervention: Procedure: percutaneous laser ablation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
November 2013
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with unresectable HCC or who refused surgery
  • A solitary HCC ≤ 5.0cm in diameter, or multiple HCC ≤ 3 lesions, each ≤ 3.0cm in diameter
  • Child-Pugh class A or B
  • Platelet count correctable to > 40,000/mm3, INR correctable to < 2.0
  • No previous treatment of HCC

Exclusion Criteria:

  • Other severe concomitant diseases that may reduce life expectancy
  • History of encephalopathy, refractory ascites or variceal bleeding
  • Vascular invasion or extrahepatic metastasis
  • Human immunodeficiency virus (HIV) infection
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  • Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01096914
epatologia1
No
Giovan Giuseppe Di Costanzo, Cardarelli Hospital
Cardarelli Hospital
Not Provided
Principal Investigator: Giovan Giuseppe Di Costanzo, MD Liver Unit - Cardarelli Hospital - Via A Cardarelli 9 - 80131 Naples-Italy
Cardarelli Hospital
January 2014

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