Radiofrequency Versus Laser Ablation for Hepatocellular Carcinoma

Cardarelli Hospital

Status: Completed

Conditions: Neoplasms, Liver; Carcinoma, Hepatocellular

Treatments: Procedure: percutaneous radiofrequency ablation; Procedure: percutaneous laser ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT01096914

epatologia1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Radiofrequency

Active Comparator group

Description:

patients treated with percutaneous radiofrequency ablation

Treatment:

Procedure: percutaneous radiofrequency ablation

laser

Active Comparator group

Description:

Patients treated with percutaneous laser ablation

Treatment:

Procedure: percutaneous laser ablation