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Irreversible Electroporation for Treatment of Solid Abdominal Tumors

Primary Purpose

Oncology

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Irreversible electroporation
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oncology

Eligibility Criteria

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

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    hepatic focal lesions and pancreatic masses

    Arm Description

    Outcomes

    Primary Outcome Measures

    The ablation success
    the ability to deliver planned therapy and to have no residual

    Secondary Outcome Measures

    Local recurrence
    defined as re appearance of viable tumor after period during which no tumor could be detected

    Full Information

    First Posted
    May 25, 2017
    Last Updated
    May 26, 2017
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03169439
    Brief Title
    Irreversible Electroporation for Treatment of Solid Abdominal Tumors
    Official Title
    Irreversible Electroporation for Treatment of Solid Abdominal Tumors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 1, 2017 (Anticipated)
    Primary Completion Date
    April 1, 2019 (Anticipated)
    Study Completion Date
    August 1, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oncology

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    25 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    hepatic focal lesions and pancreatic masses
    Arm Type
    Other
    Intervention Type
    Procedure
    Intervention Name(s)
    Irreversible electroporation
    Intervention Description
    minimal invasive ablative technique for tumors
    Primary Outcome Measure Information:
    Title
    The ablation success
    Description
    the ability to deliver planned therapy and to have no residual
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Local recurrence
    Description
    defined as re appearance of viable tumor after period during which no tumor could be detected
    Time Frame
    3,6 and 12 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hosam Abozaid Yousef, MD
    Phone
    00201063602906
    Email
    hosameldeen68@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amr Farouk Murad, MD
    Phone
    00201061035700
    Email
    amrfarouk11@hotmail.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15771276
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16830945
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    20413755
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    17668932
    Citation
    Rubinsky B. Irreversible electroporation in medicine. Technol Cancer Res Treat. 2007 Aug;6(4):255-60. doi: 10.1177/153303460700600401.
    Results Reference
    background
    PubMed Identifier
    22367010
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22648257
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    19645522
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24262034
    Citation
    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.
    Results Reference
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    Irreversible Electroporation for Treatment of Solid Abdominal Tumors

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