NCT01096914

Radiofrequency Versus Laser Ablation for Hepatocellular Carcinoma

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Cardarelli Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Carcinoma, Hepatocellular
• Neoplasms, Liver

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2009-01-01
• Primary completion: 2012-09-01
• Completion: 2013-11-01
• First posted: 2010-03-31
• Last updated: 2014-01-30

Locations

1 site across 1 country: Italy