Radiofrequency Versus Laser Ablation for Hepatocellular Carcinoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Radiofrequency Ablation Versus Laser Ablation for the Treatment of Small Hepatocellular Carcinoma: a Randomized Controlled Trial

Conditions
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Carcinoma, Hepatocellular, Neoplasms, Liver

Intervention / Treatment
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* Procedure: percutaneous radiofrequency ablation
* Procedure: percutaneous laser ablation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Radiofrequency<br>patients treated with percutaneous radiofrequency ablation | Procedure: percutaneous radiofrequency ablation<br>* 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.<br>* Other names: Cool-tip ablation system - Valleylab, USA;|
| Active Comparator: laser<br>Patients treated with percutaneous laser ablation | Procedure: percutaneous laser ablation<br>* 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.<br>* Other names: Echolaser XVG system, Italy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response | Complete ablation of the HCC nodule, defined as absence of contrast enhancement of the nodule at CT or MRI imaging | four weeks after treatment | 

Secondary Outcome Measures

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