Clinical trial · Interventional

Irreversible Electroporation for Treatment of Solid Abdominal Tumors

NCT03169439CI-TRIAL-00027817unknownN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

Irreversible electroporation (IRE) is a novel non-thermal ablation modality with promise for revolutionizing the treatment for local solid tumors. With the growing demand for alternative and less invasive treatments for localized tumors, the investigators have seen the development and investigation of several tissue ablation modalities, including radiofrequency ablation (RFA), microwave ablation, and cryoablation. Although these modalities have been efficacious, they have some disadvantages owing to their reliance on thermal energy for creating cell death.

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
Oncology	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Irreversible electroporation	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
OTHER
label
hepatic focal lesions and pancreatic masses
interventionNames
1. Procedure: Irreversible electroporation

Primary outcomes (1)

measure
The ablation success
timeFrame
3 months
description
the ability to deliver planned therapy and to have no residual

Secondary outcomes (1)

measure
Local recurrence
timeFrame
3,6 and 12 months
description
defined as re appearance of viable tumor after period during which no tumor could be detected

Eligibility

Eligibility (as posted)

Sex: All

Show eligibility criteria text

Inclusion Criteria:

* Patients with unresectable solid abdominal tumors (hepatic, pancreatic, porta hepatis,…).
* The mass measures less than 4 cm.
* Associated with no or oligo metastatic lesions

Exclusion Criteria:

* Patients with cardiac arrhythmia and pacemaker.
* Patients unfit for general anesthesia.
* The lesion size is larger than 4 cm.

References

Publications (8)

BACKGROUNDDavalos RV, Mir IL, Rubinsky B. Tissue ablation with irreversible electroporation. Ann Biomed Eng. 2005 Feb;33(2):223-31. doi: 10.1007/s10439-005-8981-8. PMID 15771276
BACKGROUNDEdd JF, Horowitz L, Davalos RV, Mir LM, Rubinsky B. In vivo results of a new focal tissue ablation technique: irreversible electroporation. IEEE Trans Biomed Eng. 2006 Jul;53(7):1409-15. doi: 10.1109/TBME.2006.873745. PMID 16830945
BACKGROUNDLee EW, Chen C, Prieto VE, Dry SM, Loh CT, Kee ST. Advanced hepatic ablation technique for creating complete cell death: irreversible electroporation. Radiology. 2010 May;255(2):426-33. doi: 10.1148/radiol.10090337. PMID 20413755
BACKGROUNDRubinsky B. Irreversible electroporation in medicine. Technol Cancer Res Treat. 2007 Aug;6(4):255-60. doi: 10.1177/153303460700600401. PMID 17668932
BACKGROUNDKasivisvanathan V, Thapar A, Oskrochi Y, Picard J, Leen EL. Irreversible electroporation for focal ablation at the porta hepatis. Cardiovasc Intervent Radiol. 2012 Dec;35(6):1531-4. doi: 10.1007/s00270-012-0363-7. Epub 2012 Feb 25. PMID 22367010
BACKGROUNDUsman M, Moore W, Talati R, Watkins K, Bilfinger TV. Irreversible electroporation of lung neoplasm: a case series. Med Sci Monit. 2012 Jun;18(6):CS43-7. doi: 10.12659/msm.882888. PMID 22648257
BACKGROUNDEsser AT, Smith KC, Gowrishankar TR, Weaver JC. Towards solid tumor treatment by nanosecond pulsed electric fields. Technol Cancer Res Treat. 2009 Aug;8(4):289-306. doi: 10.1177/153303460900800406. PMID 19645522
BACKGROUNDSilk MT, Wimmer T, Lee KS, Srimathveeravalli G, Brown KT, Kingham PT, Fong Y, Durack JC, Sofocleous CT, Solomon SB. Percutaneous ablation of peribiliary tumors with irreversible electroporation. J Vasc Interv Radiol. 2014 Jan;25(1):112-8. doi: 10.1016/j.jvir.2013.10.012. Epub 2013 Nov 18.