Clinical trial NCT01096914: 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
Overall status: COMPLETED
Phase: NA
Conditions: Carcinoma, Hepatocellular
Neoplasms, Liver
Lead sponsor: Cardarelli Hospital
Sponsor class: OTHER
First posted: 2010-03-31
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Tumor response
timeFrame: four weeks after treatment
Secondary outcomes:
measure: overall survival
timeFrame: 12 months after last treatment
measure: time to local recurrence
timeFrame: 12 months after treatment
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Liver Unit - Cardarelli Hospital
Study officials:
affiliation: Liver Unit - Cardarelli Hospital - Via A Cardarelli 9 - 80131 Naples-Italy
name: Giovan Giuseppe Di Costanzo, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.