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Irreversible Electroporation for Treatment of Solid Abdominal Tumors

Irreversible Electroporation for Treatment of Solid Abdominal Tumors

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03169439
Enrollment
25
Registered
2017-05-30
Start date
2017-07-01
Completion date
2019-08-01
Last updated
2017-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oncology

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.

Interventions

PROCEDUREIrreversible electroporation

minimal invasive ablative technique for tumors

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The ablation success3 monthsthe ability to deliver planned therapy and to have no residual

Secondary

MeasureTime frameDescription
Local recurrence3,6 and 12 monthsdefined as re appearance of viable tumor after period during which no tumor could be detected

Contacts

Primary ContactHosam Abozaid Yousef, MD
hosameldeen68@gmail.com00201063602906
Backup ContactAmr Farouk Murad, MD
amrfarouk11@hotmail.com00201061035700

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026