Radiofrequency Ablation Versus Laser Ablation for the Treatment of Small Hepatocellular Carcinoma: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Carcinoma, Hepatocellular
- Sponsor
- Cardarelli Hospital
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Tumor response
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Giovan Giuseppe Di Costanzo
MD
Cardarelli Hospital
Eligibility 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
Outcomes
Primary Outcomes
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 Outcomes
- time to local recurrence(12 months after treatment)
- overall survival(12 months after last treatment)