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Radiofrequency Versus Laser Ablation for Hepatocellular Carcinoma

C

Cardarelli Hospital

Status

Completed

Conditions

Neoplasms, Liver
Carcinoma, Hepatocellular

Treatments

Procedure: percutaneous radiofrequency ablation
Procedure: percutaneous laser ablation

Study type

Interventional

Funder types

Other

Identifiers

NCT01096914
epatologia1

Details and patient eligibility

About

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.

Full 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.

Enrollment

140 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

140 participants in 2 patient groups

Radiofrequency
Active Comparator group
Description:
patients treated with percutaneous radiofrequency ablation
Treatment:
Procedure: percutaneous radiofrequency ablation
laser
Active Comparator group
Description:
Patients treated with percutaneous laser ablation
Treatment:
Procedure: percutaneous laser ablation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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