Multipolar Radiofrequency Ablation for Hepatocellular Carcinoma Using Extra Nodular Versus Intranodular Technique

NCT01008657 | Completed DMC

• 1 other identifier: P071213
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

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

Hepatocellular Carcinomas

Keywords

Radiofrequency-Extranodular-Multipolar ablation; Recurrence

Outcome Measures

Primary Outcomes (1)

• 2 years global (local+distant) recurrence rate

  2 years

Secondary Outcomes (3)

• 2 years local recurrence rate

  2 years

• 2 years distant recurrence rate

  2 years

• Primary treatment effectiveness (assessed 1 month after completion of treatment course which can include up to 3 radiofrequency ablation (RFA) procedures performed monthly)

  2 years

Study Arms (2)

extranodular "no touch" multipolar RFA

EXPERIMENTAL

Procedure: Radiofrequency ablation

intranodular multipolar RFA

ACTIVE COMPARATOR

Procedure: Radiofrequency ablation

Interventions

Radiofrequency ablation PROCEDURE

Percutaneous multipolar radiofrequency ablation.

Also known as: radiofrequency extranodular or intanodular ablation

extranodular "no touch" multipolar RFA; intranodular multipolar RFA

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Radiology Department

Bondy, 93140, France

Location

Related Publications (13)

• Chen 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 BACKGROUND

• Kotoh 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 BACKGROUND

• Seror 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 BACKGROUND

• Harrison 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 BACKGROUND

• Mazzaferro 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 BACKGROUND

• Kotoh 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.

  PMID: 16343075 BACKGROUND

• Kotoh K, Nakamuta M, Morizono S, Kohjima M, Arimura E, Fukushima M, Enjoji M, Sakai H, Nawata H. A multi-step, incremental expansion method for radio frequency ablation: optimization of the procedure to prevent increases in intra-tumor pressure and to reduce the ablation time. Liver Int. 2005 Jun;25(3):542-7. doi: 10.1111/j.1478-3231.2005.01051.x.

  PMID: 15910491 BACKGROUND

• Nakamuta M, Kohjima M, Morizono S, Yoshimoto T, Miyagi Y, Sakai H, Enjoji M, Kotoh K. Comparison of tissue pressure and ablation time between the LeVeen and cool-tip needle methods. Comp Hepatol. 2006 Dec 21;5:10. doi: 10.1186/1476-5926-5-10.

  PMID: 17181870 BACKGROUND

• Okusaka T, Okada S, Ueno H, Ikeda M, Shimada K, Yamamoto J, Kosuge T, Yamasaki S, Fukushima N, Sakamoto M. Satellite lesions in patients with small hepatocellular carcinoma with reference to clinicopathologic features. Cancer. 2002 Nov 1;95(9):1931-7. doi: 10.1002/cncr.10892.

  PMID: 12404287 BACKGROUND

• Pawlik TM, Delman KA, Vauthey JN, Nagorney DM, Ng IO, Ikai I, Yamaoka Y, Belghiti J, Lauwers GY, Poon RT, Abdalla EK. Tumor size predicts vascular invasion and histologic grade: Implications for selection of surgical treatment for hepatocellular carcinoma. Liver Transpl. 2005 Sep;11(9):1086-92. doi: 10.1002/lt.20472.

  PMID: 16123959 BACKGROUND

• Shi M, Guo RP, Lin XJ, Zhang YQ, Chen MS, Zhang CQ, Lau WY, Li JQ. Partial hepatectomy with wide versus narrow resection margin for solitary hepatocellular carcinoma: a prospective randomized trial. Ann Surg. 2007 Jan;245(1):36-43. doi: 10.1097/01.sla.0000231758.07868.71.

  PMID: 17197963 BACKGROUND

• Seror O, N'Kontchou G, Ibraheem M, Ajavon Y, Barrucand C, Ganne N, Coderc E, Trinchet JC, Beaugrand M, Sellier N. Large (>or=5.0-cm) HCCs: multipolar RF ablation with three internally cooled bipolar electrodes--initial experience in 26 patients. Radiology. 2008 Jul;248(1):288-96. doi: 10.1148/radiol.2481071101. Epub 2008 May 15.

  PMID: 18483229 BACKGROUND

• Wong IH, Yeo W, Leung T, Lau WY, Johnson PJ. Circulating tumor cell mRNAs in peripheral blood from hepatocellular carcinoma patients under radiotherapy, surgical resection or chemotherapy: a quantitative evaluation. Cancer Lett. 2001 Jun 26;167(2):183-91. doi: 10.1016/s0304-3835(01)00455-4.

  PMID: 11369140 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Recurrence

Interventions

Radiofrequency Ablation

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Olivier Seror, professor

  Radiology Department, CHU-Jean Verdier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2009
• First Posted: November 6, 2009
• Study Start: February 9, 2010
• Primary Completion: October 6, 2016
• Study Completion: October 6, 2016
• Last Updated: August 29, 2017

Record last verified: 2017-08

Locations

FR (1)