Carcinoma, HepatocellularNCT01096914
Radiofrequency Versus Laser Ablation for Hepatocellular Carcinoma
A study testing percutaneous radiofrequency ablation and percutaneous laser ablation in people with Carcinoma, Hepatocellular and Neoplasms, Liver, run by Cardarelli Hospital at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Carcinoma, Hepatocellular, Neoplasms, Liver
- What is being tested?
- percutaneous radiofrequency ablation and percutaneous laser ablation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2009to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Carcinoma, Hepatocellular, Neoplasms, Liver
- Being tested
- percutaneous radiofrequency ablation, percutaneous laser ablation
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous radiofrequency ablationProcedure or surgery
Also called Cool-tip ablation system - Valleylab, USA
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.
percutaneous laser ablationProcedure or surgery
Also called Echolaser XVG system, Italy
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.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency | Active comparator | patients treated with percutaneous radiofrequency ablation Receives: Procedure: percutaneous radiofrequency ablation |
| laser | Active comparator | Patients treated with percutaneous laser ablation Receives: Procedure: percutaneous laser ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response
Complete ablation of the HCC nodule, defined as absence of contrast enhancement of the nodule at CT or MRI imaging
Measured: four weeks after treatment
Secondary outcomes (2)
overall survival
Time from randomization to death. Patients alive at the end of follow-up are censored.
Measured: 12 months after last treatment
time to local recurrence
the time from complete tumor ablation to reappearance of arterial enhancement on CT or MRI either within a treated tumor or near its borders
Measured: 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2010 (estimated)
- Study startJan 2009
- Primary completionSep 2012
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardarelli Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovan Giuseppe Di Costanzo, Cardarelli Hospital
- Investigators
- Giovan Giuseppe Di Costanzo, MD, Principal investigator, Liver Unit - Cardarelli Hospital - Via A Cardarelli 9 - 80131 Naples-Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01096914
- Sponsor's protocol ID
- epatologia1
- Status last verified
- Jan 2014
- First submitted
- 30 Mar 2010
- Last updated
- 30 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 19332729Germani 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.
PubMed 20149473Ferrari 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.
PubMed 17447018
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation Versus Laser Ablation for the Treatment of Small Hepatocellular Carcinoma: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01096914
- Acronym / sponsor ID
- epatologia1
- Conditions
- Carcinoma, Hepatocellular, Neoplasms, Liver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Cardarelli HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 31 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency | Active comparator | Procedure: percutaneous radiofrequency ablationpatients treated with percutaneous radiofrequency ablation |
| laser | Active comparator | Procedure: percutaneous laser ablationPatients treated with percutaneous laser ablation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| percutaneous radiofrequency ablationAlso: Cool-tip ablation system - Valleylab, USAProcedure: 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. | Procedure or surgery | Radiofrequency |
| percutaneous laser ablationAlso: Echolaser XVG system, ItalyProcedure: 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. | Procedure or surgery | laser |
Primary outcome
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
2 secondary outcomes
overall survival
Time frame: 12 months after last treatment
time to local recurrence
Time frame: 12 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2014.
- Background: PubMed 19332729Pacella 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.
- Background: PubMed 20149473Germani 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.
- Background: PubMed 17447018Ferrari 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovan Giuseppe Di Costanzo, MD principal investigator
Liver Unit - Cardarelli Hospital - Via A Cardarelli 9 - 80131 Naples-Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing percutaneous radiofrequency ablation and percutaneous laser ablation in people with Carcinoma, Hepatocellular and Neoplasms, Liver, run by Cardarelli Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor response (time frame: four weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01096914, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2014.