Clinical trial · Interventional
Multipolar Radiofrequency Ablation for Hepatocellular Carcinoma Using Extra Nodular Versus Intranodular Technique
Multipolar Radiofrequency Ablation for the Treatment of Hepatocellular Carcinoma Using Classical Intranodular Technique Versus Extra Nodular Technique So-called "No Touch" Technique: A Prospective Randomized Trial
NCT01008657CI-TRIAL-00029318ARMCENVINcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary purpose of the trial is to demonstrate that at least a 40% drop of recurrence rate can be achieve in hepatocellular carcinoma patients treated with no touch multipolar radiofrequency ablation technique compared to those treated with usual intranodular multipolar technique.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinomas | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiofrequency ablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- extranodular "no touch" multipolar RFA
- interventionNames
- Procedure: Radiofrequency ablation
- type
- ACTIVE_COMPARATOR
- label
- intranodular multipolar RFA
- interventionNames
- Procedure: Radiofrequency ablation
Primary outcomes (1)
- measure
- 2 years global (local+distant) recurrence rate
- timeFrame
- 2 years
Secondary outcomes (3)
- measure
- 2 years local recurrence rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults \> 18 years old, holder of up to 3 nodules less than 4 cm in diameter * Diagnosis of hepatocellular carcinoma according to American Society of Liver Study non invasive criteria or based on histological proof * Non invasive diagnosis of cirrhosis according to French Haute Authority of illness guideline or based on histological proof * No previous treatment for hepatocellular carcinoma * Multidisciplinary decision of treatment by radiofrequency ablation Exclusion Criteria: * Adult patient under guardianship or trusteeship, homeless * Patient with potentially short term life-threatening serious co-infection (apart from viral B or C, or VIH co-infection) * Pregnant or breastfeeding woman * Patient for whom regular follow-up is impossible whatever the cause * Contra indication to general anaesthesia * Technical impossibility to perform the procedure under ultrasound guidance * Boundary of the tumor located at less than 1 cm distance from colonic wall or main biliary tract (main right or left bill ducts and common bill duct) * Tumor invisible with ultrasound * Lack of safe percutaneous course which can be planned * Tumor in which more than four biopsies pass were previously performed (cumulated during one or several previous biopsies sessions) * Contra indication to perform CT or MRI with contrast medium (GADOLINITE or iodinate) intravenous injection * Child-Pugh B or C cirrhosis (apart from the transitory liver failures in the setting of acute hepatitis related to alcohol abuse) * Total detachment of the anterior face of the liver from internal abdominal wall due to abundant ascites. * Prothrombin activity \< 50 % * Platelet count \<40 .10 3/ml * Platelet dysfunction or congenital impaired blood coagulating
References
Publications (13)
- BACKGROUNDChen MS, Li JQ, Zheng Y, Guo RP, Liang HH, Zhang YQ, Lin XJ, Lau WY. A prospective randomized trial comparing percutaneous local ablative therapy and partial hepatectomy for small hepatocellular carcinoma. Ann Surg. 2006 Mar;243(3):321-8. doi: 10.1097/01.sla.0000201480.65519.b8. PMID 16495695
- BACKGROUNDKotoh K, Enjoji M, Arimura E, Morizono S, Kohjima M, Sakai H, Nakamuta M. Scattered and rapid intrahepatic recurrences after radio frequency ablation for hepatocellular carcinoma. World J Gastroenterol. 2005 Nov 21;11(43):6828-32. doi: 10.3748/wjg.v11.i43.6828. PMID 16425391
- BACKGROUNDSeror O, N'Kontchou G, Tin-Tin-Htar M, Barrucand C, Ganne N, Coderc E, Trinchet JC, Sellier N, Beaugrand M. Radiofrequency ablation with internally cooled versus perfused electrodes for the treatment of small hepatocellular carcinoma in patients with cirrhosis. J Vasc Interv Radiol. 2008 May;19(5):718-24. doi: 10.1016/j.jvir.2008.01.007. Epub 2008 Mar 17. PMID 18440461
- BACKGROUNDHarrison LE, Koneru B, Baramipour P, Fisher A, Barone A, Wilson D, Dela Torre A, Cho KC, Contractor D, Korogodsky M. Locoregional recurrences are frequent after radiofrequency ablation for hepatocellular carcinoma. J Am Coll Surg. 2003 Nov;197(5):759-64. doi: 10.1016/S1072-7515(03)00750-6. PMID 14585410
- BACKGROUNDMazzaferro V, Battiston C, Perrone S, Pulvirenti A, Regalia E, Romito R, Sarli D, Schiavo M, Garbagnati F, Marchiano A, Spreafico C, Camerini T, Mariani L, Miceli R, Andreola S. Radiofrequency ablation of small hepatocellular carcinoma in cirrhotic patients awaiting liver transplantation: a prospective study. Ann Surg. 2004 Nov;240(5):900-9. doi: 10.1097/01.sla.0000143301.56154.95. PMID 15492574
- BACKGROUNDKotoh K, Morizono S, Kohjima M, Enjoji M, Sakai H, Nakamuta M. Evaluation of liver parenchymal pressure and portal endothelium damage during radio frequency ablation in an in vivo porcine model. Liver Int. 2005 Dec;25(6):1217-23. doi: 10.1111/j.1478-3231.2005.01167.x.