Comparison Between Radiofrequency Versus Ethanol Injection for the Treatment of Hepatocellular Carcinoma

NCT00355212 | Terminated Phase 3

• 1 other identifier: 3909/562/35/2000
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Ethanol injection has been for many years the standard approach as percutaneous treatment of non-surgical early hepatocellular carcinoma in cirrhotic patients. Radiofrequency ablation has been proposed as an alternative approach and some retrospective and prospective comparative trials indicated its better performance for the local control of the disease in comparison to ethanol injection. Some prospective randomized studies from Japan and from Taiwan reported also an increase of overall survival in the patients treated by Radiofrequency. Aim of this study is to compare the two techniques in a prospective randomized trial in western patients.

Conditions

Carcinoma, Hepatocellular

Keywords

percutaneous ethanol injection; radiofrequency; liver cirrhosis; carcinoma, hepatocellular

Outcome Measures

Primary Outcomes (1)

• Sustained complete response at one year after the treatment.

Secondary Outcomes (4)

• early complete response(forty days after treatment)

• overall survival at the fourth year after the first treatment

• complications

• costs.

Interventions

percutaneous ablation of hepatocellular carcinoma PROCEDURE

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Included were cirrhotic patients in Child-Pugh class A/B with 1 to 3 HCC nodes of ≤ 30mm in diameter.

You may not qualify if:

• Excluded were patients without liver cirrhosis, in Child-Pugh class C, with a platelets count \<40000, INR \>1.75, PTT \>40sec, hypo vascular HCC, lesions not detectable by ultrasonography (US), lesions close (≤1cm) to the gallbladder, hepatic hilum, colon or stomach, with venous invasion or metastatic disease

Sponsors & Collaborators

• Azienda Ospedaliera San Giovanni Battista: lead

Study Sites (1)

Azienda Ospedaliera San Giovanni Battista di Torino

Torino, 10126, Italy

Location

Related Publications (1)

• Lencioni RA, Allgaier HP, Cioni D, Olschewski M, Deibert P, Crocetti L, Frings H, Laubenberger J, Zuber I, Blum HE, Bartolozzi C. Small hepatocellular carcinoma in cirrhosis: randomized comparison of radio-frequency thermal ablation versus percutaneous ethanol injection. Radiology. 2003 Jul;228(1):235-40. doi: 10.1148/radiol.2281020718. Epub 2003 May 20.

  PMID: 12759473 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Franco Brunello, MD

  Azienda Ospedaliera San Giovanni Battista di Torino

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 19, 2006
• First Posted: July 21, 2006
• Study Start: January 1, 2001
• Study Completion: March 1, 2006
• Last Updated: July 25, 2006

Record last verified: 2006-03

Locations

IT (1)