Carcinoma, Hepatocellular, Neoplasms, Liver
Conditions
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.
Interventions
PROCEDUREpercutaneous 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.
PROCEDUREpercutaneous 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.
Sponsors
Cardarelli Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 12 months after last treatment | Time from randomization to death. Patients alive at the end of follow-up are censored. |
| 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 |
Countries
Italy
Outcome results
None listed