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

Primary Purpose

Hepatocellular Carcinomas

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Radiofrequency ablation
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinomas focused on measuring Radiofrequency-Extranodular-Multipolar ablation, Recurrence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Radiology Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

extranodular "no touch" multipolar RFA

intranodular multipolar RFA

Arm Description

Outcomes

Primary Outcome Measures

2 years global (local+distant) recurrence rate

Secondary Outcome Measures

2 years local recurrence rate
2 years distant recurrence rate
Primary treatment effectiveness (assessed 1 month after completion of treatment course which can include up to 3 radiofrequency ablation (RFA) procedures performed monthly)

Full Information

First Posted
November 5, 2009
Last Updated
August 28, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01008657
Brief Title
Multipolar Radiofrequency Ablation for Hepatocellular Carcinoma Using Extra Nodular Versus Intranodular Technique
Acronym
ARMCENVIN
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
February 9, 2010 (Actual)
Primary Completion Date
October 6, 2016 (Actual)
Study Completion Date
October 6, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
206 patients with hepatocellular carcinoma(s) including up to three nodules measuring up to four cm in diameter, will be randomized in two therapeutic legs: multipolar no touch radiofrequency versus multipolar intra nodular radiofrequency. Patients previously treated for hepatocellular carcinoma will not be enrolled in the study. Diagnostic of hepatocellular carcinoma will be based on American Society of Liver Diseases guide line. Early response to the treatment will be assessed one month after the radiofrequency ablation procedures (up to three in case of incomplete necrosis) with dynamic contrast medium enhanced CT or MRI liver examinations. For the follow up dynamic contrast medium enhanced CT or MRI liver examinations will be performed every three months. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinomas
Keywords
Radiofrequency-Extranodular-Multipolar ablation, Recurrence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
extranodular "no touch" multipolar RFA
Arm Type
Experimental
Arm Title
intranodular multipolar RFA
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency ablation
Other Intervention Name(s)
radiofrequency extranodular or intanodular ablation
Intervention Description
Percutaneous multipolar radiofrequency ablation.
Primary Outcome Measure Information:
Title
2 years global (local+distant) recurrence rate
Time Frame
2 years
Secondary Outcome Measure Information:
Title
2 years local recurrence rate
Time Frame
2 years
Title
2 years distant recurrence rate
Time Frame
2 years
Title
Primary treatment effectiveness (assessed 1 month after completion of treatment course which can include up to 3 radiofrequency ablation (RFA) procedures performed monthly)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Seror, professor
Organizational Affiliation
Radiology Department, CHU-Jean Verdier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radiology Department
City
Bondy
ZIP/Postal Code
93140
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
16495695
Citation
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.
Results Reference
background
PubMed Identifier
16425391
Citation
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.
Results Reference
background
PubMed Identifier
18440461
Citation
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.
Results Reference
background
PubMed Identifier
14585410
Citation
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.
Results Reference
background
PubMed Identifier
15492574
Citation
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.
Results Reference
background
PubMed Identifier
16343075
Citation
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.
Results Reference
background
PubMed Identifier
15910491
Citation
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.
Results Reference
background
PubMed Identifier
17181870
Citation
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.
Results Reference
background
PubMed Identifier
12404287
Citation
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.
Results Reference
background
PubMed Identifier
16123959
Citation
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.
Results Reference
background
PubMed Identifier
17197963
Citation
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.
Results Reference
background
PubMed Identifier
18483229
Citation
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.
Results Reference
background
PubMed Identifier
11369140
Citation
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.
Results Reference
background

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

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