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Radiofrequency Versus Laser Ablation for Hepatocellular Carcinoma

Primary Purpose

Carcinoma, Hepatocellular, Neoplasms, Liver

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

percutaneous radiofrequency ablation

percutaneous laser ablation

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Liver Unit - Cardarelli Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Radiofrequency

laser

Arm Description

patients treated with percutaneous radiofrequency ablation

Patients treated with percutaneous laser ablation

Outcomes

Primary Outcome Measures

Tumor response

Complete ablation of the HCC nodule, defined as absence of contrast enhancement of the nodule at CT or MRI imaging

Secondary Outcome Measures

overall survival

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

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

Full Information

NCT ID

NCT01096914

First Posted

March 30, 2010

Last Updated

January 28, 2014

Sponsor

Cardarelli Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01096914

Brief Title

Radiofrequency Versus Laser Ablation for Hepatocellular Carcinoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cardarelli Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Hepatocellular, Neoplasms, Liver

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

140 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Radiofrequency

Arm Type

Active Comparator

Arm Description

patients treated with percutaneous radiofrequency ablation

Arm Title

laser

Arm Type

Active Comparator

Arm Description

Patients treated with percutaneous laser ablation

Intervention Type

Procedure

Intervention Name(s)

percutaneous radiofrequency ablation

Other Intervention Name(s)

Cool-tip ablation system - Valleylab, USA

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

percutaneous laser ablation

Other Intervention Name(s)

Echolaser XVG system, Italy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Tumor response

Description

Complete ablation of the HCC nodule, defined as absence of contrast enhancement of the nodule at CT or MRI imaging

Time Frame

four weeks after treatment

Secondary Outcome Measure Information:

Title

overall survival

Description

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

Time Frame

12 months after last treatment

Title

time to local recurrence

Description

the time from complete tumor ablation to reappearance of arterial enhancement on CT or MRI either within a treated tumor or near its borders

Time Frame

12 months after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Giovan Giuseppe Di Costanzo, MD

Organizational Affiliation

Liver Unit - Cardarelli Hospital - Via A Cardarelli 9 - 80131 Naples-Italy

Official's Role

Principal Investigator

Facility Information:

Facility Name

Liver Unit - Cardarelli Hospital

City

Naples

ZIP/Postal Code

80131

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

19332729

Citation

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.

Results Reference

background

PubMed Identifier

20149473

Citation

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.

Results Reference

background

PubMed Identifier

17447018

Citation

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.

Results Reference

background

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Radiofrequency Versus Laser Ablation for Hepatocellular Carcinoma

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