Hepatocellular CarcinomasARMCENVINNCT01008657

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

A study testing Radiofrequency ablation in people with Hepatocellular Carcinomas, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatocellular Carcinomas
What is being tested?: Radiofrequency ablation
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 216 participants
Where: 1 siteFrance
Study dates: 9 Feb 2010to 6 Oct 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 16Show fewer

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

Trial locations and contacts

1 site in 1 country.

France1 site

Radiology Department
Bondy, 93140

Other trials in France

About this study

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

Read the 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.

Conditions: Hepatocellular Carcinomas
Being tested: Radiofrequency ablation
Keywords: Radiofrequency-Extranodular-Multipolar ablation, Recurrence
Medical subject headings: Carcinoma, Hepatocellular, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Radiofrequency ablationProcedure or surgery
Also called radiofrequency extranodular or intanodular ablation
Percutaneous multipolar radiofrequency ablation.

Study groups in NCT01008657
Study group	Role	What they receive
extranodular "no touch" multipolar RFA	Experimental	Not described Receives: Procedure: Radiofrequency ablation
intranodular multipolar RFA	Active comparator	Not described Receives: Procedure: Radiofrequency ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

2 years global (local+distant) recurrence rate
Measured: 2 years

Secondary outcomes (3)

2 years local recurrence rate
Measured: 2 years
2 years distant recurrence rate
Measured: 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)
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Feb 20106 Oct 2016

First posted6 Nov 2009 (estimated)
Study start9 Feb 2010
Primary completion6 Oct 2016
Study completion6 Oct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Hepatocellular CarcinomasStudies of the same condition, open and under way.
More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 216 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01008657
Sponsor's protocol ID: P071213
Acronym: ARMCENVIN
Status last verified: Aug 2017
First submitted: 5 Nov 2009
Last updated: 29 Aug 2017
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 16495695
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.
PubMed 16425391
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.
PubMed 18440461
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.
PubMed 14585410
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.
PubMed 15492574
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.
PubMed 16343075
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.
PubMed 15910491
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.
PubMed 17181870
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.
PubMed 12404287
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.
PubMed 16123959
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.
PubMed 17197963
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.
PubMed 18483229
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.
PubMed 11369140

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hepatocellular Carcinomas trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01008657
Acronym / sponsor ID: ARMCENVIN / P071213
Conditions: Hepatocellular Carcinomas
Keywords: Radiofrequency-Extranodular-Multipolar ablation, Recurrence
Study type: Interventional
Recruitment status: Completed
Enrolment: 216 participants (actual)
Lead sponsor: Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
Study start: 9 Feb 2010 (actual)
Primary completion: 6 Oct 2016 (actual)
Study completion: 6 Oct 2016 (actual)
First posted: 6 Nov 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
extranodular "no touch" multipolar RFA	Experimental	Procedure: Radiofrequency ablation
intranodular multipolar RFA	Active comparator	Procedure: Radiofrequency ablation

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (16 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Radiofrequency ablationAlso: radiofrequency extranodular or intanodular ablationPercutaneous multipolar radiofrequency ablation.	Procedure or surgery	extranodular "no touch" multipolar RFA, intranodular multipolar RFA

Primary outcome

2 years global (local+distant) recurrence rate
Time frame: 2 years

3 secondary outcomes

2 years local recurrence rate
Time frame: 2 years
2 years distant recurrence rate
Time frame: 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)
Time frame: 2 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
Background: PubMed 16495695Chen 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.
Background: PubMed 16425391Kotoh 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.
Background: PubMed 18440461Seror 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.
Background: PubMed 14585410Harrison 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.
Background: PubMed 15492574Mazzaferro 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.
Background: PubMed 16343075Kotoh 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.
Background: PubMed 15910491Kotoh 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.
Background: PubMed 17181870Nakamuta 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.
Background: PubMed 12404287Okusaka 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.
Background: PubMed 16123959Pawlik 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.
Background: PubMed 17197963Shi 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.
Background: PubMed 18483229Seror 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.

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Not yet recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Olivier Seror, professor principal investigator

Radiology Department, CHU-Jean Verdier

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Radiofrequency ablation in people with Hepatocellular Carcinomas, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2 years global (local+distant) recurrence rate (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01008657, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2017.