Radiofrequency Versus Laser Ablation for Hepatocellular Carcinoma

Carcinoma, Hepatocellular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01096914
• Other study ID #: epatologia1
• Status: Completed
• Phase: N/A
• First received: March 30, 2010
• Last updated: January 28, 2014
• Start date: January 2009
• Est. completion date: November 2013

Study information

• Verified date: January 2014
• Source: Cardarelli Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: November 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Liver Neoplasms
• Neoplasms, Liver

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Liver Unit - Cardarelli Hospital	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Cardarelli Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. Epub 2007 Apr 20. English, Italian. — View Citation

Germani G, Pleguezuelo M, Gurusamy K, Meyer T, Isgrò 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor response	Complete ablation of the HCC nodule, defined as absence of contrast enhancement of the nodule at CT or MRI imaging	four weeks after treatment	No
Secondary	overall survival	Time from randomization to death. Patients alive at the end of follow-up are censored.	12 months after last treatment	No
Secondary	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	12 months after treatment	No