The goal of this single-center observational cohort study, based on a registry combining retrospectively and prospectively collected data, is to investigate the short- and long-term effects of irreversible electroporation (IRE) in men and women over the age of 18 who receive IRE for recurrence of pelvic tumors not suitable for other local treatment options such as surgery, thermal ablation, and radiotherapy. The main question it aims to answer is whether IRE is safe in this population, and secondarily, whether it is effective in controlling local tumor recurrence.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Measurable disease described on pre-treatment imaging (CT/MRI/PET-CT) (max 6 weeks prior);
* IRE of a recurrent pelvic tumor;
* Unsuitable for other local therapies (surgery/stereotactic body radiation therapy) as described during the multidisciplinary tumor board;
Exclusion Criteria:
* If the treated tumor was biopsied directly prior to MWA and pathology proves the lesion to represent a benign entity;
* Inadequate or insufficient data registered;
* Inadequate or insufficient follow-up;
Primary outcome measure(s)
Incidence and Severity of Adverse Events (CTCAE v5.0) — Assessed up to 5 years. Safety of IRE, assessed by the rate and severity of adverse events per procedure and per patient, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Incidence and Classification of Nerve Injury (Seddon Classification) — Assessed up to 5 years. Nerve injuries related to IRE, assessed per procedure and per patient, classified according to Seddon's classification as neurapraxia, axonotmesis, or neurotmesis.
Trial sites (1)
Facility
City
Region
Status
Amsterdam UMC
Amsterdam
North Holland
Recruiting
More Amsterdam UMC, location VUmc trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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