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Completed

NCT Number: NCT01096914

Radiofrequency Versus Laser Ablation for Hepatocellular Carcinoma

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.

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Key information

Conditions

Carcinoma, Hepatocellular Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Liver

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liver Unit - Cardarelli Hospital

Naples, 80131, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous Radiofrequency Ablation

Procedure

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.

Other names: Cool-tip ablation system - Valleylab, USA

Percutaneous Laser Ablation

Procedure

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.

Other names: Echolaser XVG system, Italy

Primary outcomes

  1. 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

  1. overall survival

    Time frame: 12 months after last treatment

    Time from randomization to death. Patients alive at the end of follow-up are censored.

  2. time to local recurrence

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cardarelli Hospital

Other

Registry information

Official study title

Radiofrequency Ablation Versus Laser Ablation for the Treatment of Small Hepatocellular Carcinoma: a Randomized Controlled Trial

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Mar 31, 2010
Registry last updated
Jan 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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