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

About this trial
This is an interventional treatment trial for Oncology
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.
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
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
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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
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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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