- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01096914
Radiofrequency Versus Laser Ablation for Hepatocellular Carcinoma
January 28, 2014 updated by: Giovan Giuseppe Di Costanzo, Cardarelli Hospital
Radiofrequency Ablation Versus Laser Ablation for the Treatment of Small Hepatocellular Carcinoma: a Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
140
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Naples, Italy, 80131
- Liver Unit - Cardarelli Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Radiofrequency
patients treated with 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 Names:
|
Active Comparator: laser
Patients treated with 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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor response
Time Frame: four weeks after treatment
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Complete ablation of the HCC nodule, defined as absence of contrast enhancement of the nodule at CT or MRI imaging
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four weeks after treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival
Time Frame: 12 months after last treatment
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Time from randomization to death.
Patients alive at the end of follow-up are censored.
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12 months after last treatment
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time to local recurrence
Time Frame: 12 months after treatment
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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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12 months after treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Giovan Giuseppe Di Costanzo, MD, Liver Unit - Cardarelli Hospital - Via A Cardarelli 9 - 80131 Naples-Italy
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Pacella CM, Francica G, Di Lascio FM, Arienti V, Antico E, Caspani B, Magnolfi F, Megna AS, Pretolani S, Regine R, Sponza M, Stasi R. Long-term outcome of cirrhotic patients with early hepatocellular carcinoma treated with ultrasound-guided percutaneous laser ablation: a retrospective analysis. J Clin Oncol. 2009 Jun 1;27(16):2615-21. doi: 10.1200/JCO.2008.19.0082. Epub 2009 Mar 30.
- Germani G, Pleguezuelo M, Gurusamy K, Meyer T, Isgro G, Burroughs AK. Clinical outcomes of radiofrequency ablation, percutaneous alcohol and acetic acid injection for hepatocelullar carcinoma: a meta-analysis. J Hepatol. 2010 Mar;52(3):380-8. doi: 10.1016/j.jhep.2009.12.004. Epub 2010 Jan 17.
- Ferrari FS, Megliola A, Scorzelli A, Stella A, Vigni F, Drudi FM, Venezia D. Treatment of small HCC through radiofrequency ablation and laser ablation. Comparison of techniques and long-term results. Radiol Med. 2007 Apr;112(3):377-93. doi: 10.1007/s11547-007-0148-2. Epub 2007 Apr 20. English, Italian.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
September 1, 2012
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
March 30, 2010
First Submitted That Met QC Criteria
March 30, 2010
First Posted (Estimate)
March 31, 2010
Study Record Updates
Last Update Posted (Estimate)
January 30, 2014
Last Update Submitted That Met QC Criteria
January 28, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- epatologia1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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