Radiofrequency Versus Laser Ablation for Hepatocellular Carcinoma

Not Applicable

Completed

• Conditions: Carcinoma, Hepatocellular; Neoplasms, Liver
• Interventions: Procedure: percutaneous radiofrequency ablation; Procedure: percutaneous laser ablation

• Registration Number: NCT01096914
• Lead Sponsor: Cardarelli Hospital

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.

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 Timeline

• Study Start: 2009-01
• Study First Submitted: 2010-03-30
• Study First Submitted QC: 2010-03-30
• Study First Posted: 2010-03-31
• Primary Completion: 2012-09
• Study Completion: 2013-11
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-28
• Last Update Posted: 2014-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiofrequency	percutaneous radiofrequency ablation	patients treated with percutaneous radiofrequency ablation
laser	percutaneous laser ablation	Patients treated with percutaneous laser ablation

Primary Outcome Measures

Name	Time	Method
Tumor response	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

Name	Time	Method
time to local recurrence	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
overall survival	12 months after last treatment	Time from randomization to death. Patients alive at the end of follow-up are censored.

Trial Locations

Locations (1)

Liver Unit - Cardarelli Hospital; 🇮🇹 Naples, Italy