Irreversible Electroporation for the Ablation of Renal Cell Carcinoma: A Prospective, Human, In Vivo Study Protocol (IDEAL Phase 2b)

Abstract

BackgroundIrreversible electroporation (IRE) is an emerging technique delivering electrical pulses to ablate tissue, with the theoretical advantage to overcome the main shortcomings of conventional thermal ablation. Recent short-term research showed that IRE for the ablation of renal masses is a safe and feasible treatment option. In an ablate and resect design, histopathological analysis 4 weeks after radical nephrectomy demonstrated that IRE-targeted renal tumors were completely covered by ablation zone. In order to develop a validated long-term IRE follow-up study, it is essential to obtain clinical confirmation of the efficacy of this novel technology. Additionally, follow-up after IRE ablation obliges verification of a suitable imaging modality.ObjectiveThe objectives of this study are the clinical efficacy and safety of IRE ablation of renal masses and to evaluate the use of cross-sectional imaging modalities in the follow-up after IRE in renal tumors. This study conforms to the recommendations of the IDEAL Collaboration and can be categorized as a phase 2B exploration trial.MethodsIn this prospective clinical trial, IRE will be performed in 20 patients aged 18 years and older presenting with a solid enhancing small renal mass (SRM) (≤4 cm) who are candidates for ablation. Magnetic resonance imaging (MRI) and contrast-enhanced ultrasound (CEUS) will be performed at 1 day pre-IRE, and 1 week post-IRE. Computed tomography (CT), CEUS, and MRI will be performed at 3 months, 6 months, and 12 months post-IRE.ResultsPresently, recruitment of patients has started and the first inclusions are completed. Preliminary results and outcomes are expected in 2018.ConclusionsTo establish the position of IRE ablation for treating renal tumors, a structured stepwise assessment in clinical practice is required. This study will offer fundamental knowledge on the clinical efficacy of IRE ablation for SRMs, potentially positioning IRE as ablative modality for renal tumors and accrediting future research with long-term follow-up.Trial RegistrationClinicaltrials.gov registration number NCT02828709; https://clinicaltrials.gov/ct2/show/NCT02828709 (archived by WebCite at http://www.webcitation.org/6nmWK7Uu9). Dutch Central Committee on Research Involving Human Subjects NL56935.018.16

Selective Inactivation ofPseudomonas aeruginosaandStaphylococcus epidermidiswith Pulsed Electric Fields and Antibiotics

“…Further translation of the PEF to wound healing clinics will require detailed safety studies as PEF will affect both bacteria and host cells. Studies on irreversible electroporation safety in humans have demonstrated that the procedure is safe, 86,87 especially if the delivery of pulses is electrocardiographically synchronized. 88 Pain studies on patients with deep-tissue tumors showed no difference in comparison with other ablation methods.…”

Outcome selection, measurement and reporting for new surgical procedures and devices: a systematic review of IDEAL/IDEAL-D studies to inform development of a core outcome set

“…Initial screening identified 62 of 136 records (45·6 per cent) for full‐text eligibility assessment. Finally, 48 relevant publications (42 study reports, 6 protocols) were included in the analysis 24–71 ( Fig . 1 ).…”

Available ablation energies to treat cT1 renal cell cancer: emerging technologies

“…Canvasser et al published about 42 renal tumors for which CT-guided IRE was performed [ 26 ]. Buijs et al submitted a paper presenting the preliminary results of ten patients who underwent percutaneous IRE [ 27 ].…”

“…Mainly minor complications were reported and consisted of perinephric hematomas, post-procedural pain and urinary retention. The major complications reported in two studies were transient gross hematuria in a hilar tumor and stage 1 acute kidney failure [ 22 , 27 ]. Renal function decline was minimal, but was not always reported.…”

“…A high percentage of residual disease was reported (range 7–37.5%). Some of the authors suggested that residual tumor was most likely the result of probe malpositioning [ 21 , 26 , 27 ]. Wendler et al have done extensive work on IRE in the IRENE study in which patients underwent percutaneous CT-guided IRE and 4 weeks later radical or partial nephrectomy.…”