Radiofrequency Ablation Versus Laser Ablation for the Treatment of Small Hepatocellular Carcinoma: a Randomized Controlled Trial
18 Years
85 Years
Both
Carcinoma, Hepatocellular, Neoplasms, Liver
Trial Information
Radiofrequency Ablation Versus Laser Ablation for the Treatment of Small Hepatocellular Carcinoma: a Randomized Controlled Trial
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Tumor response
Outcome Description:
Complete ablation of the HCC nodule, defined as absence of contrast enhancement of the nodule at CT or MRI imaging
Outcome Time Frame:
four weeks after treatment
Safety Issue:
No
Principal Investigator
Giovan Giuseppe Di Costanzo, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Liver Unit - Cardarelli Hospital - Via A Cardarelli 9 - 80131 Naples-Italy
Authority:
Italy: Ethics Committee
Study ID:
epatologia1
NCT ID:
NCT01096914
Start Date:
January 2009
Completion Date:
September 2013
Related Keywords:
- Carcinoma, Hepatocellular
- Neoplasms, Liver
- Neoplasms
- Carcinoma
- Liver Neoplasms
- Carcinoma, Hepatocellular
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