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Safety of on- vs off-clamp robotic partial nephrectomy: per-protocol analysis from the data of the CLOCK randomized trial

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Abstract

Purpose

To compare the safety of on- vs off-clamp robotic partial nephrectomy (RAPN).

Methods

302 patients with RENAL masses ≤ 10 were randomized to undergo on-clamp (150) vs off-clamp (152) RAPN (CLOCK trial—ClinicalTrials.gov NCT02287987) at seven institutions by one experienced surgeon per institution. Intra-operative data, complications, and positive surgical margins were compared.

Results

Due to a relevant rate of shift from the assigned treatment, the per-protocol analysis only was considered and the data from 129 on-clamp vs 91 off-clamp RAPNs analyzed. Tumor size (off-clamp vs on-clamp, 2.2 vs 3.0 cm, p < 0.001) and RENAL score (5 vs 6, p < 0.001) significantly differed. At univariate analysis, no differences were found regarding intra-operative estimated blood loss (off- vs on-clamp, 100 vs 100 ml, p = 0.7), post-operative complications rate (19% vs 26%, p = 0.2), post-operative anemia (Hb decrease > 2.5 g/dl 26% vs 27%, p = 0.9; transfusion rate 3.4% vs 6.3%, p = 0.5; re-intervention due to bleeding 1.1% vs 4%, p = 0.4), acute kidney injury (4% vs 6%, p = 0.8), and positive surgical margins (3.5% vs 8.2%, p = 0.1). At multivariate analysis accounting for tumor diameter and complexity, considering the on-clamp group as the reference category, a significant difference was noted in the off-clamp group exclusively for blood loss (OR 0.3, 95% CI 0.09–0.52, p = 0.008).

Conclusions

The on-clamp and off-clamp approaches for RAPN showed a comparable safety profile.

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References

  1. Campbell S, Uzzo RG, Allaf ME et al (2017) Renal mass and localized renal cancer: AUA guideline. J Urol 198:520–529. https://doi.org/10.1016/j.juro.2017.04.100

    Article  PubMed  Google Scholar 

  2. Ljungberg B, Albiges L, Abu-Ghanem Y et al (2019) European association of urology guidelines on renal cell carcinoma: the 2019 update. Eur Urol 75:799–810. https://doi.org/10.1016/j.eururo.2019.02.011

    Article  PubMed  Google Scholar 

  3. Antonelli A, Minervini A, Sandri M et al (2018) Below safety limits, every unit of glomerular filtration rate counts: assessing the relationship between renal function and cancer-specific mortality in renal cell carcinoma. Eur Urol 74:661–667. https://doi.org/10.1016/j.eururo.2018.07.029 (Epub 2018 Aug 10)

    Article  PubMed  Google Scholar 

  4. Marconi L, Desai MM, Ficarra V, Porpiglia F, Van Poppel H (2016) Renal preservation and partial nephrectomy: patient and surgical factors. Eur Urol Focus 2:589–600. https://doi.org/10.1016/j.euf.2017.02.012

    Article  PubMed  Google Scholar 

  5. Bertolo R, Campi R, Klatte T et al (2018) Suture techniques during laparoscopic and robot-assisted partial nephrectomy: a systematic review and quantitative synthesis of peri-operative outcomes. BJU Int. https://doi.org/10.1111/bju.14537(Epub ahead of print)

    Article  PubMed  Google Scholar 

  6. Volpe A, Blute ML, Ficarra V et al (2015) Renal ischemia and function after partial nephrectomy: a collaborative review of the literature. Eur Urol 68:61–74. https://doi.org/10.1016/j.eururo.2015.01.025

    Article  PubMed  Google Scholar 

  7. Mir MC, Autorino R, Porpiglia F (2018) Ischemia time and beyond: the concept of global renal damage. Minerva Urol Nefrol 70:447–449. https://doi.org/10.23736/S0393-2249.18.03253-8

    Article  PubMed  Google Scholar 

  8. Simone G, Gill IS, Mottrie A, Kutikov A, Patard JJ, Alcaraz A, Rogers CG (2015) Indications, techniques, outcomes, and limitations for minimally ischemic and off-clamp partial nephrectomy: a systematic review of the literature. Eur Urol 68:632–640. https://doi.org/10.1016/j.eururo.2015.04.020

    Article  PubMed  Google Scholar 

  9. Minervini A, Vittori G, Antonelli A et al (2014) Open versus robotic-assisted partial nephrectomy: a multicenter comparison study of perioperative results and complications. World J Urol 32:287–293. https://doi.org/10.1007/s00345-013-1136-x

    Article  PubMed  Google Scholar 

  10. Guillonneau B, Berm H, Gholami S et al (2003) Laparoscopic partial nephrectomy for renal tumor: single center experience comparing clamping and no clamping techniques of the renal vasculature. J Urol 169:483–486. https://doi.org/10.1097/01.ju.0000045225.64349.bf

    Article  CAS  PubMed  Google Scholar 

  11. Papalia R, Simone G, Ferriero M et al (2012) Laparoscopic and robotic partial nephrectomy without renal ischaemia for tumours larger than 4 cm: perioperative and functional outcomes. World J Urol 30:671–676. https://doi.org/10.1007/s00345-012-0961-7

    Article  PubMed  Google Scholar 

  12. Schiavina R, Mari A, Antonelli A et al (2015) A snapshot of nephron-sparing surgery in Italy: a prospective, multicenter report on clinical and perioperative outcomes (the RECORd 1 project). Eur J Surg Oncol 41:346. https://doi.org/10.1016/j.ejso.2014.12.001

    Article  CAS  PubMed  Google Scholar 

  13. Antonelli A, Mari A, Longo N et al (2018) Role of clinical and surgical factors for the prediction of immediate, early and late functional results, and its relationship with cardiovascular outcome after partial nephrectomy: results from the Prospective Multicenter RECORd 1 Project. J Urol 199:927–932. https://doi.org/10.1016/j.juro.2017.11.065

    Article  PubMed  Google Scholar 

  14. Cindolo L, Antonelli A, Sandri M et al (2019) The role of vascular clamping during robot-assisted partial nephrectomy for localized renal cancer: rationale and design of the CLOCK randomized phase III study. Minerva Urol Nefrol 71:96–100. https://doi.org/10.23736/S0393-2249.18.03357-X

    Article  PubMed  Google Scholar 

  15. Levey AS, Stevens LA (2010) Estimating GFR using the CKD epidemiology collaboration (CKD-EPI) creatinine equation: more accurate GFR estimates, lower CKD prevalence estimates, and better risk predictions. Am J Kidney Dis 55:622–627. https://doi.org/10.1053/j.ajkd.2010.02.337

    Article  PubMed  PubMed Central  Google Scholar 

  16. Kutikov A, Uzzo RG (2009) The RENAL nephrometry score: a comprehensive standardized system for quantitating renal tumor size, location and depth. J Urol 182:844–853. https://doi.org/10.1016/j.juro.2009.05.035

    Article  PubMed  Google Scholar 

  17. Kaczmarek BF, Tanagho YS, Hillyer SP et al (2013) Off-clamp robot-assisted partial nephrectomy preserves renal function: a multi-institutional propensity score analysis. Eur Urol 64:988–993. https://doi.org/10.1016/j.eururo.2012.10.009

    Article  PubMed  Google Scholar 

  18. Rosenberger WF, Lachin JM (2002) Randomization in clinical trials—theory and practice. John Wiley and Sons, New York

    Book  Google Scholar 

  19. Charlson ME, Pompei P, Ales KL et al (1987) A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis 40:373

    Article  CAS  PubMed  Google Scholar 

  20. Minervini A, Carini M, Uzzo RG, Campi R, Smaldone MC, Kutikov A (2014) Standardized reporting of resection technique during nephron-sparing surgery: the surface–intermediate–base margin score. Eur Urol 66:803–805. https://doi.org/10.1016/j.eururo.2014.06.002

    Article  PubMed  Google Scholar 

  21. Antonelli A, Furlan M, Sodano M, Carobbio F, Tardanico R, Fisogni S, Simeone C (2017) External histopathological validation of the surface–intermediate-base margin score. Urol Oncol 35:215–220. https://doi.org/10.1016/j.urolonc.2016.12.011

    Article  PubMed  Google Scholar 

  22. Dindo D, Demartines N, Clavien P-A (2004) Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 240:205–213. https://doi.org/10.1097/01.sla.0000133083.54934.ae

    Article  PubMed  PubMed Central  Google Scholar 

  23. Bellomo R, Ronco C, Kellum JA, Mehta RL, Palevsky P, Acute Dialysis Quality Initiative workgroup (2004) Acute renal failure—definition, outcome measures, animal models, fluid therapy and information technology needs: the Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group. Crit Care 8:R204–R212. https://doi.org/10.1186/cc2872

    Article  PubMed  PubMed Central  Google Scholar 

  24. Antonelli A, Cindolo L, Sandri M et al (2019) Predictors of the transition from off to on clamp approach during ongoing robotic partial nephrectomy: data from the CLOCK randomized clinical trial. J Urol. https://doi.org/10.1097/JU.0000000000000194

    Article  PubMed  Google Scholar 

  25. Dagenais J, Bertolo R, Garisto J et al (2019) Variability in partial nephrectomy outcomes: does your surgeon matter? Eur Urol 75:628–634. https://doi.org/10.1016/j.eururo.2018.10.046

    Article  PubMed  Google Scholar 

  26. Greco F, Autorino R, Altieri V et al (2018) Ischemia techniques in nephron-sparing surgery: a systematic review and meta-analysis of surgical, oncological, and functional outcomes. Eur Urol 75:477–491. https://doi.org/10.1016/j.eururo.2018.10.005

    Article  PubMed  PubMed Central  Google Scholar 

  27. Antonelli A, Veccia A, Francavilla S et al (2019) On clamp versus off clamp robotic partial nephrectomy: a systematic review and meta analysis. Urologia 86:52–62

    Article  PubMed  Google Scholar 

  28. Bertolo R, Simone G, Garisto J et al (2018) Off-clamp vs on-clamp robotic partial nephrectomy: perioperative, functional and oncological outcomes from a propensity-score matching between two high-volume centers. Eur J Surg Oncol 1:2. https://doi.org/10.1016/j.ejso.2018.12.005

    Article  Google Scholar 

  29. Anderson BG, Potretzke AM, Du K et al (2019) Comparing off-clamp and on-clamp robot-assisted partial nephrectomy: a prospective randomized trial. Urology 126:102–109. https://doi.org/10.1016/j.urology.2018.11.053

    Article  PubMed  Google Scholar 

  30. Bertolo R, Antonelli A, Sandri M et al (2019) Re: comparing off-clamp and on-clamp robot-assisted partial nephrectomy: a prospective randomized trial. Urology 128:113–114. https://doi.org/10.1016/j.urology.2019.02.017

    Article  PubMed  Google Scholar 

  31. Bertolo R, Capitanio U, Kidney Cancer Working Group of the Young Academic Urologists Working Party of the European Association of Urology (2019) Re: acute kidney injury after partial nephrectomy in solitary kidneys: impact on long-term stability of renal function. Eur Urol 75:346–348. https://doi.org/10.1016/j.eururo.2018.10.043

    Article  PubMed  Google Scholar 

  32. Antonelli A, Allinovi M, Cocci A et al (2018) The predictive role of biomarkers for the detection of acute kidney injury after partial or radical nephrectomy: a systematic review of the literature. Eur Urol Focus. https://doi.org/10.1016/j.euf.2018.09.020

    Article  PubMed  Google Scholar 

  33. Krauss A (2018) Why all randomised controlled trials produce biased results. Ann Med 50:312–322. https://doi.org/10.1080/07853890.2018.1453233

    Article  PubMed  Google Scholar 

  34. Pavan N, Derweesh I, Hampton LJ et al (2018) Retroperitoneal robotic partial nephrectomy: systematic review and cumulative analysis of comparative outcomes. J Endourol 32:591–596. https://doi.org/10.1089/end.2018.0211

    Article  PubMed  Google Scholar 

Download references

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Authors and Affiliations

  1. Urology Unit, ASST Spedali Civili Hospital and Department of Medical and Surgical Specialties, Radiological Science, and Public Health, University of Brescia, Brescia, Italy

    Alessandro Antonelli, Maria Furlan, Claudio Simeone & Alessandro Veccia

  2. Urology Unit, D’Annunzio Hospital, University of Chieti, Chieti, Italy

    Luca Cindolo, Carlo D’Orta, Manuela Ingrosso, Giulia Primiceri & Luigi Schips

  3. Data Methods and Systems Statistical Laboratory, University of Brescia, Brescia, Italy

    Marco Sandri

  4. Urology Unit, San Carlo di Nancy Hospital, Rome, Italy

    Riccardo Bertolo

  5. Urology Unit, San Donato Hospital, Arezzo, Italy

    Filippo Annino & Valentina Giommoni

  6. Urology Unit, Careggi Hospital, University of Florence, Florence, Italy

    Marco Carini, Andrea Mari, Gianluca Muto, Francesco Sessa & Andrea Minervini

  7. Urology Unit, San Bassiano Hospital, Bassano Del Grappa, Italy

    Antonio Celia & Bernardino De Concilio

  8. Urology Unit, Misericordia Hospital, Grosseto, Italy

    Roberto Nucciotti

  9. Urology Unit, Policlinico of Abano, Abano Terme, Italy

    Angelo Porreca

Authors
  1. Alessandro Antonelli
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Consortia

The AGILE Group (Italian Group for Advanced Laparo-Endoscopic Surgery)

Contributions

Protocol/project development: Alessandro Antonelli, Luca Cindolo, Marco Sandri, Andrea Minervini. Data collection or management: Filippo Annino, Marco Carini, Antonio Celia, Carlo, D’Orta, Bernardino De Concilio, Maria Furlan, Valentina Giommoni, Manuela Ingrosso, Andrea Mari, Gianluca Muto, Roberto Nucciotti, Angelo Porreca, Giulia Primiceri, Luigi Schips, Francesco Sessa, AlessandroVeccia. Data analysis: Marco Sandri, Alessandro Antonelli, Andrea Minervini, Riccardo Bertolo. Manuscript writing/editing: Alessandro Antonelli, Riccardo Bertolo, Marco Sandri, Alessandro Veccia, Andrea Minervini

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Correspondence to Alessandro Antonelli.

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Antonelli, A., Cindolo, L., Sandri, M. et al. Safety of on- vs off-clamp robotic partial nephrectomy: per-protocol analysis from the data of the CLOCK randomized trial. World J Urol 38, 1101–1108 (2020). https://doi.org/10.1007/s00345-019-02879-4

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