Multipolar Radiofrequency Ablation for Hepatocellular Carcinoma Using Extra Nodular Versus Intranodular Technique
NCT ID: NCT01008657
Last Updated: 2017-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
216 participants
INTERVENTIONAL
2010-02-09
2016-10-06
Brief Summary
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Detailed Description
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The trial will last for 73 months including 45 months for the recruitment of patients. The main criteria of judgement will be the 2-years recurrence rate.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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extranodular "no touch" multipolar RFA
Radiofrequency ablation
Percutaneous multipolar radiofrequency ablation.
intranodular multipolar RFA
Radiofrequency ablation
Percutaneous multipolar radiofrequency ablation.
Interventions
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Radiofrequency ablation
Percutaneous multipolar radiofrequency ablation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Olivier Seror, professor
Role: PRINCIPAL_INVESTIGATOR
Radiology Department, CHU-Jean Verdier
Locations
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Radiology Department
Bondy, , France
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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P071213
Identifier Type: -
Identifier Source: org_study_id
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