Radiofrequency Versus Laser Ablation for Hepatocellular Carcinoma

• ClinicalTrials.gov Identifier: NCT01096914
• Recruitment Status: Completed
• First Posted: March 31, 2010
• Last Update Posted: January 30, 2014
• Sponsor: Cardarelli Hospital
• Information provided by (Responsible Party): Giovan Giuseppe Di Costanzo, Cardarelli Hospital

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Carcinoma, Hepatocellular; Neoplasms, Liver	Procedure: percutaneous radiofrequency ablation; Procedure: percutaneous laser ablation	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Radiofrequency Ablation Versus Laser Ablation for the Treatment of Small Hepatocellular Carcinoma: a Randomized Controlled Trial
• Study Start Date: January 2009
• Actual Primary Completion Date: September 2012
• Actual Study Completion Date: November 2013

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Tumor response [ Time Frame: four weeks after treatment ]
   Complete ablation of the HCC nodule, defined as absence of contrast enhancement of the nodule at CT or MRI imaging

Secondary Outcome Measures :

1. overall survival [ Time Frame: 12 months after last treatment ]
   Time from randomization to death. Patients alive at the end of follow-up are censored.
2. time to local recurrence [ Time Frame: 12 months after treatment ]
   the time from complete tumor ablation to reappearance of arterial enhancement on CT or MRI either within a treated tumor or near its borders

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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:

Pacella CM, Francica G, Di Lascio FM, Arienti V, Antico E, Caspani B, Magnolfi F, Megna AS, Pretolani S, Regine R, Sponza M, Stasi R. Long-term outcome of cirrhotic patients with early hepatocellular carcinoma treated with ultrasound-guided percutaneous laser ablation: a retrospective analysis. J Clin Oncol. 2009 Jun 1;27(16):2615-21. doi: 10.1200/JCO.2008.19.0082. Epub 2009 Mar 30.

Germani G, Pleguezuelo M, Gurusamy K, Meyer T, Isgrò G, Burroughs AK. Clinical outcomes of radiofrequency ablation, percutaneous alcohol and acetic acid injection for hepatocelullar carcinoma: a meta-analysis. J Hepatol. 2010 Mar;52(3):380-8. doi: 10.1016/j.jhep.2009.12.004. Epub 2010 Jan 17.

Ferrari FS, Megliola A, Scorzelli A, Stella A, Vigni F, Drudi FM, Venezia D. Treatment of small HCC through radiofrequency ablation and laser ablation. Comparison of techniques and long-term results. Radiol Med. 2007 Apr;112(3):377-93. Epub 2007 Apr 20. English, Italian.

• Responsible Party: Giovan Giuseppe Di Costanzo, MD, Cardarelli Hospital
• ClinicalTrials.gov Identifier: NCT01096914
• Other Study ID Numbers: epatologia1
• First Posted: March 31, 2010
• Last Update Posted: January 30, 2014
• Last Verified: January 2014

Additional relevant MeSH terms:

Liver Neoplasms; Liver Diseases; Carcinoma; Carcinoma, Hepatocellular; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases