Irreversible Electroporation for Treatment of Solid Abdominal Tumors

NCT ID: NCT03169439

Last Updated: 2017-05-30

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2019-08-01

Brief Summary

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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.

Detailed Description

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Irreversible electroporation is novel in that it does not use thermal energy, but electrical energy to produce focused cell death while sparing the normal extracellular matrix, nearby vessels, and structures, while allowing for rapid normal tissue regrowth.

Unlike thermal ablation modalities, Irreversible electroporation does not require significant consideration for dissipation of thermal energy, or heat sink, and has less complications relating to damage of normal soft tissue, eliminating a major cause of treatment failure.

Irreversible electroporation is a novel minimally invasive tumor/tissue ablation technique that can be used under guidance of ultrasound (US) or computed tomography (CT), without inducing thermal damaging effects, and with preservation of the surrounding vital structures such as vessels, bile ducts, urethra, and nerves which remain intact to function normally, even in locally advanced tumors. The technique depends upon inducing apoptotic non-necrotic cell death in short procedure time.

It has the advantage of allowing quick tissue regeneration. Irreversible electroporation treatment time is significantly shorter than traditional thermal ablation modalities, usually in few minutes range, and allows for treating considerably larger lesions than thermal ablation modalities.

Conditions

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Oncology

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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hepatic focal lesions and pancreatic masses

Group Type OTHER

Irreversible electroporation

Intervention Type PROCEDURE

minimal invasive ablative technique for tumors

Interventions

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Irreversible electroporation

minimal invasive ablative technique for tumors

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Jolie Welson

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Hosam Abozaid Yousef, MD

Role: CONTACT

00201063602906

Amr Farouk Murad, MD

Role: CONTACT

00201061035700

References

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Davalos 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.

Reference Type BACKGROUND
PMID: 15771276 (View on PubMed)

Edd 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.

Reference Type BACKGROUND
PMID: 16830945 (View on PubMed)

Lee 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.

Reference Type BACKGROUND
PMID: 20413755 (View on PubMed)

Rubinsky B. Irreversible electroporation in medicine. Technol Cancer Res Treat. 2007 Aug;6(4):255-60. doi: 10.1177/153303460700600401.

Reference Type BACKGROUND
PMID: 17668932 (View on PubMed)

Kasivisvanathan 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.

Reference Type BACKGROUND
PMID: 22367010 (View on PubMed)

Usman 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.

Reference Type BACKGROUND
PMID: 22648257 (View on PubMed)

Esser 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.

Reference Type BACKGROUND
PMID: 19645522 (View on PubMed)

Silk 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.

Reference Type BACKGROUND
PMID: 24262034 (View on PubMed)

Other Identifiers

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IREAT

Identifier Type: -

Identifier Source: org_study_id

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