Irreversible Electroporation for Treatment of Solid Abdominal Tumors

Study Overview
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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.

Official Title
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Irreversible Electroporation for Treatment of Solid Abdominal Tumors

Conditions
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Oncology

Intervention / Treatment
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* Procedure: Irreversible electroporation


Participation Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: hepatic focal lesions and pancreatic masses<br> | Procedure: Irreversible electroporation<br>* minimal invasive ablative technique for tumors<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ablation success | the ability to deliver planned therapy and to have no residual | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local recurrence | defined as re appearance of viable tumor after period during which no tumor could be detected | 3,6 and 12 months |