Follow-up after focal therapy in renal masses: an international multidisciplinary Delphi consensus project

Zondervan, Patricia J.; Wagstaff, Peter G. K.; Desai, Manisha; Bruin, Daniël M. de; Fraga, A. F.; Hadaschik, Boris; Köllermann, Jens; Liehr, Uwe-Bernd; Pahernik, Sascha; Schlemmer, HP; Wendler, Johann Jakob; Algaba, Ferrán; Rosette, Jean J.M.C.H. de la; Pes, M. Pilar Laguna

doi:10.1007/s00345-016-1828-0

Cited by 14 publications

(7 citation statements)

References 27 publications

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“…In our opinion, it is crucial to investigate the clinical efficacy of IRE in renal tumors to serve as a solid base for a large randomized trial. We aim to determine the clinical effect of IRE by assessing the presence of enhancement on cross-sectional imaging during follow-up as it is advised in thermal ablation [30]. Whereas IRE is a novel ablation technology, posttreatment radiological features in CT scan or MRI are still ill-defined.…”

Section: Discussionmentioning

confidence: 99%

“…Despite the fact that biopsy during the follow-up targeting the ablation zone may contribute to histopathological confirmation, it would have brought additional burden in a fragile population and would not have been an irrefutable proof of complete ablation. Therefore, as provided by the consensus that ablation success in kidney tumors is assessed by radiological characteristics [30], success in our study will be assessed exclusively based on radiological features.…”

Section: Discussionmentioning

confidence: 99%

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

Buijs¹,

Lienden²,

Wagstaff³

et al. 2017

JMIR Res Protoc

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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

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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

Buijs¹,

Lienden²,

Wagstaff³

et al. 2017

JMIR Res Protoc

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“…The initiative followed a rigorous, systematic methodology with multiple iterations to achieve a consensus. We recruited a large number of multidisciplinary research experts and achieved similar response rates to those observed in other Delphi surveys performed in a urological setting [15,16,24,25]. The response rate increased during subsequent survey iterations.…”

Section: Methodological Considerationsmentioning

confidence: 96%

Essential Research Priorities in Renal Cancer: A Modified Delphi Consensus Statement

Rossi

Blick

Handforth

et al. 2020

European Urology Focus

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Background: Identification of clear and focused research priorities is crucial to drive research forward. Objective: To identify research priorities in renal cell carcinoma (RCC) through a multidisciplinary collaboration between clinicians, researchers, and patients. Design, setting, and participants: In phase I, 44 RCC experts provided 24 literature reviews within their field, summarising research gaps (RGs). Three expert discussion meetings and patient interviews were performed, and 39 potential RGs were identified. In phase II, experts (N = 82) scored these gaps on a nine-point scale (1-3: not important; 4-6: important; 7-9: critical) through a multistep Delphi process involving three online surveys and two further consensus meetings. The surveys aimed to reach a consensus, defined as 70% agreement by experts. Outcome measurements and statistical analysis: Three iterations of the Delphi survey were performed. The results obtained after the third Delphi survey were distributed amongst the RCC experts and patient representatives for final feedback. Results and limitations: In the first Delphi survey, the response rate was 56% (46/82), increasing to 67% (55/82) and 71% (58/82) in the second and third iterations, respectively. Survey respondents included 45.7% urologists, 37.0% oncologists, 8.7% radiologists, and 8.6% other specialists (pathologists, health economists, geneticist, and scientists). The process resulted in the identification of 14 crucial RGs, across a broad range of RCC themes. Key themes included further research into systemic therapies for RCC and management strategies that maximise quality of life, especially in patient groups that are "difficult to treat" and have rarer RCC subtypes. Two crucial RGs relate to biomarkers and novel imaging approaches for both localised and metastatic disease, to enable prognostic risk stratification and individualise patient management. Study participants were from a UK and European setting; therefore, we acknowledge that the RGs identified represent European priorities. Conclusions: These RGs will facilitate international collaboration towards a concerted attempt to improve patients' survival and quality of life.

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“…The oncological outcomes (persistence, local recurrence, systemic progression, overall [OS], disease-specific [DSS], and local recurrence-free survival [RFS]) were analysed for patients with biopsy confirmed RCC ( n = 131). Persistence was defined as residual tumour (contrast enhancement in the ablation site) on first imaging (at 3 months), whereas local recurrence was defined as any contrast enhancement on follow-up imaging at the site of ablation after initial imaging without contrast enhancement [ 7 ]. The OS was defined as the duration from date of LCA to death or 5-year follow-up, with no restriction on the cause of death.…”

Section: Methodsmentioning

confidence: 99%

“…All postoperative imaging for follow-up was interpreted by a board of certified abdominal radiologists with special expertise in focal therapy for kidney cancer. According to the international multidisciplinary Delphi consensus project by Zondervan et al [7], presence of any radiological enhancement at the 3-month radiological follow-up was considered as persistence. A new (after a period of non-enhancement) enhancing or growing lesion, inside or in the margin of the ablated zone was considered local recurrence.…”

Section: Follow-upmentioning

confidence: 99%

Laparoscopic cryoablation for small renal masses: Oncological outcomes at 5-year follow-up

Henderickx

Sträter-Ruiter

West

et al. 2020

Arab Journal of Urology

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Objective : To evaluate the oncological outcome at 5-year follow-up after laparoscopic cryoablation (LCA) for small renal masses (SRMs), as there is an increasing interest in ablative therapy for cT1a renal tumours due to the rising incidence of SRMs, the trend towards minimally invasive nephron-sparing treatments, and the ageing population. Patients and methods : Between 2004 and 2015, 233 consecutive LCA were performed in 219 patients for SRMs at two referral centres. We only included those patients with ≥5 years of follow-up ( n = 165) in a prospectively maintained database. A descriptive analysis was conducted for pre-, peri- and postoperative characteristics. A Kaplan–Meier analysis assessed overall (OS), disease-specific (DSS), and recurrence-free survival (RFS). Results : The median (interquartile range [IQR]) age of our patient cohort was 68 (60.5–76) years. The median (IQR) body mass index was 26.2 (23.8–29) kg/m 2 , and the median (IQR) Charlson Comorbidity Index score corrected for age was 4 (2.5–6). The median (IQR) tumour diameter was 28 (21–33) mm. In all, 15% developed a complication in the first 30 days after LCA, of which 1% had a major complication (Clavien–Dindo Grade ≥III). The median (IQR) preoperative estimated glomerular filtration rate (eGFR) was 82.5 (65–93.75) mL/min/1.73 m 2 . The median eGFR decreased by 16.4% and 15.2% at the 3-month and 5-year follow-up, respectively. Persistence was found in 1%, local recurrence in 2%, and systemic progression in 4%. The OS, DSS, and RFS were 74%, 96.9% and 95.4%, respectively. Conclusion : LCA is a safe and effective treatment for SRMs in selected cases and shows good oncological outcomes after 5 years of follow-up, with only 1% developing a major complication.

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Follow-up after focal therapy in renal masses: an international multidisciplinary Delphi consensus project

Cited by 14 publications

References 27 publications

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

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

Essential Research Priorities in Renal Cancer: A Modified Delphi Consensus Statement

Laparoscopic cryoablation for small renal masses: Oncological outcomes at 5-year follow-up

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