Radiofrequency Versus Laser Ablation for Hepatocellular Carcinoma

NCT01096914 | Completed

• 1 other identifier: epatologia1
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Hepatocellular; Neoplasms, Liver

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• overall survival

  12 months after last treatment

• time to local recurrence

  12 months after treatment

Study Arms (2)

Radiofrequency

ACTIVE COMPARATOR

patients treated with percutaneous radiofrequency ablation

Procedure: percutaneous radiofrequency ablation

laser

ACTIVE COMPARATOR

Patients treated with percutaneous laser ablation

Procedure: percutaneous laser ablation

Interventions

percutaneous radiofrequency ablation PROCEDURE

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.

Also known as: Cool-tip ablation system - Valleylab, USA

Radiofrequency

percutaneous laser ablation PROCEDURE

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.

Also known as: Echolaser XVG system, Italy

laser

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardarelli Hospital: lead

Study Sites (1)

Liver Unit - Cardarelli Hospital

Naples, 80131, Italy

Location

Related Publications (3)

• 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.

  PMID: 19332729 BACKGROUND

• 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.

  PMID: 20149473 BACKGROUND

• 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.

  PMID: 17447018 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Giovan Giuseppe Di Costanzo, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 30, 2010
• First Posted: March 31, 2010
• Study Start: January 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: November 1, 2013
• Last Updated: January 30, 2014

Record last verified: 2014-01

Locations

IT (1)