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
  Purpose

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.


Condition Intervention
Carcinoma, Hepatocellular
Neoplasms, Liver
Procedure: percutaneous radiofrequency ablation
Procedure: percutaneous laser ablation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Radiofrequency Ablation Versus Laser Ablation for the Treatment of Small Hepatocellular Carcinoma: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Cardarelli Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 140
Study Start Date: January 2009
Study Completion Date: November 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Radiofrequency
patients treated with percutaneous radiofrequency ablation
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
Active Comparator: laser
Patients treated with percutaneous laser ablation
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01096914

Locations
Italy
Liver Unit - Cardarelli Hospital
Naples, Italy, 80131
Sponsors and Collaborators
Cardarelli Hospital
Investigators
Principal Investigator: Giovan Giuseppe Di Costanzo, MD Liver Unit - Cardarelli Hospital - Via A Cardarelli 9 - 80131 Naples-Italy
  More Information

Publications:
Responsible Party: Giovan Giuseppe Di Costanzo, MD, Cardarelli Hospital
ClinicalTrials.gov Identifier: NCT01096914     History of Changes
Other Study ID Numbers: epatologia1
Study First Received: March 30, 2010
Last Updated: January 28, 2014
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on October 29, 2014