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.
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;
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;
Consecutive patients treated with irreversible electroporation (IRE) for recurrent pelvic tumors at Amsterdam UMC starting from December 2012, identified from a dedicated institutional registry. Patients had recurrent pelvic disease not amenable to other local treatment options (surgery, stereotactic body radiotherapy, or thermal ablation), as determined by a multidisciplinary tumor board including medical oncology, radiation oncology, surgical oncology, diagnostic and interventional radiology, and pathology.
Cohort
Other
Irreversible electroporation
Procedure/SurgeryIrreversible electroporation
Incidence and Severity of Adverse Events (CTCAE v5.0)
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)
Nerve injuries related to IRE, assessed per procedure and per patient, classified according to Seddon's classification as neurapraxia, axonotmesis, or neurotmesis.
Overall survival (OS) per patient.
Overall survival is defined as the time from IRE procedure to the time of death due to any cause or to the last day of follow up (censored).
Progression-free survival (PFS; per patient analysis)
The time until the date of unequivocal disease progression (local site recurrence or metastatic disease) or death from any cause, whichever occurs first, assessed up to 10 years.
Distant tumor progression-free survival (DPFS) per patient.
Distant tumor progression-free survival is defined as the time from randomization to the time of unequivocal distant tumor progression.
Local tumor progression-free survival (LTPFS) per patient and per tumor.
Local tumor progression-free survival is defined as the time from IRE procedure to the time of unequivocal local tumor progression.
Length of Post-procedural Hospital Stay
Length of hospital stay following the IRE procedure, in days. Collected to descriptively explore potential associations with lesion and patient characteristics (e.g., lesion type, tumor location).
Tumor markers
Correlation between serum tumor marker levels (e.g., CA19-9, CEA) and radiological tumor response following IRE. Tumor marker dynamics will be explored as potential biomarkers for early treatment efficacy and recurrence.
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