Radiofrequency Versus Laser Ablation for Hepatocellular Carcinoma
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ClinicalTrials.gov Identifier: NCT01096914 |
Recruitment Status :
Completed
First Posted : March 31, 2010
Last Update Posted : January 30, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Carcinoma, Hepatocellular Neoplasms, Liver | Procedure: percutaneous radiofrequency ablation Procedure: percutaneous laser ablation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 140 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Radiofrequency Ablation Versus Laser Ablation for the Treatment of Small Hepatocellular Carcinoma: a Randomized Controlled Trial |
Study Start Date : | January 2009 |
Actual Primary Completion Date : | September 2012 |
Actual Study Completion Date : | November 2013 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Radiofrequency
patients treated with percutaneous radiofrequency ablation
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Procedure: percutaneous 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.
Other Name: Cool-tip ablation system - Valleylab, USA |
Active Comparator: laser
Patients treated with percutaneous laser ablation
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Procedure: percutaneous 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.
Other Name: Echolaser XVG system, Italy |
- 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
- overall survival [ Time Frame: 12 months after last treatment ]Time from randomization to death. Patients alive at the end of follow-up are censored.
- 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

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01096914
Italy | |
Liver Unit - Cardarelli Hospital | |
Naples, Italy, 80131 |
Principal Investigator: | Giovan Giuseppe Di Costanzo, MD | Liver Unit - Cardarelli Hospital - Via A Cardarelli 9 - 80131 Naples-Italy |
Responsible Party: | Giovan Giuseppe Di Costanzo, MD, Cardarelli Hospital |
ClinicalTrials.gov Identifier: | NCT01096914 |
Other Study ID Numbers: |
epatologia1 |
First Posted: | March 31, 2010 Key Record Dates |
Last Update Posted: | January 30, 2014 |
Last Verified: | January 2014 |
Liver Neoplasms Liver Diseases Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Adenocarcinoma Digestive System Neoplasms Neoplasms by Site Digestive System Diseases |