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  • Renal hypothermia during partial nephrectomy for patients with renal tumours: a randomised controlled clinical trial protocol

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Urology
Protocol
Renal hypothermia during partial nephrectomy for patients with renal tumours: a randomised controlled clinical trial protocol
  1. Rodney H Breau1,2,
  2. Ilias Cagiannos1,
  3. Greg Knoll2,
  4. Christopher Morash1,
  5. Sonya Cnossen2,
  6. Luke T Lavallée1,2,
  7. Ranjeeta Mallick2,
  8. Antonio Finelli3,
  9. Michael Jewett3,
  10. Bradley C Leibovich4,
  11. Jonathan Cook5,
  12. Louise LeBel2,
  13. Anil Kapoor6,
  14. Frederic Pouliot7,
  15. Jonathan Izawa8,
  16. Ricardo Rendon9,
  17. Dean A Fergusson2
  1. 1 Division of Urology, Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada
  2. 2 Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
  3. 3 Division of Urology, Departments of Surgery and Surgical Oncology, Princess Margaret Cancer Centre, University Health Network and the University of Toronto, Toronto, Ontario, Canada
  4. 4 Department of Urology, Mayo Clinic, Rochester, Minnesota, USA
  5. 5 Oxford Clinical Trial Research Unit, University of Oxford, Oxford, UK
  6. 6 Division of Urology, McMaster University, Hamilton, Ontario, Canada
  7. 7 Division of Urology, Université Laval, Quebec City, Quebec, Canada
  8. 8 Division of Urology, Department of Surgery, Western University, London, Ontario, Canada
  9. 9 Department of Urology, Dalhousie University, Halifax, Nova Scotia, Canada
  1. Correspondence to Dr Rodney H Breau; rbreau{at}toh.on.ca

Abstract

Introduction Partial nephrectomy is a standard of care for non-metastatic renal tumours when technically feasible. Despite the increased use of partial nephrectomy, intraoperative techniques that lead to optimal renal function after surgery have not been rigorously studied. Clamping of the renal hilum to prevent bleeding during resection causes temporary renal ischaemia. The internal temperature of the kidney may be lowered after the renal hilum is clamped (renal hypothermia) in an attempt to mitigate the effects of ischaemia. Our objective is to determine if renal hypothermia during open partial nephrectomy results in improved postoperative renal function at 12 months following surgery as compared with warm ischaemia (no renal hypothermia).

Methods and analyses This is a multicentre, randomised, single-blinded controlled trial comparing renal hypothermia versus no hypothermia during open partial nephrectomy. Due to the nature of the intervention, complete blinding of the surgical team is not possible; however, surgeons will be blinded until the time of hilar clamping. Glomerular filtration will be based on plasma clearance of a radionucleotide, and differential renal function will be based on renal scintigraphy. The primary outcome is overall renal function at 12 months measured by the glomerular filtration rate (GFR). Secondary outcomes include change in GFR, GFR of the affected kidney, change in GFR of the affected kidney, serum creatinine, haemoglobin, spot urine albumin to creatinine ratio, quality of life and postoperative complications. Data will be collected at baseline, immediately postoperatively and at 3, 6, 9 and 12 months postoperatively.

Ethics and dissemination Ethics approval was obtained for all participating study sites. Results of the trial will be submitted for publication in a peer-reviewed journal.

Trial registration number NCT01529658; Pre-results.

  • partial nephrectomy
  • cold ischemia
  • renal hypothermia
  • renal function
  • kidney cancer

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2018-025662

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    Footnotes

    • Contributors RHB, IC, GK, CM, RM, AF, MJ, BCL, JC, AK, FP, JI, RR and DAF contributed to the conception and design of the study. RHB, IC, GK, AF, MJ, BCL, JC, LL, AK, FP, JI, RR and DAF were involved in obtaining funding. RHB, IC, CM, SC, LTL, RM and LL contributed to data collection and/or analysis. All authors were involved in drafting the manuscript. All authors read and approved the final manuscript.

    • Funding This work was supported by the Canadian Institutes of Health Research (CIHR) grant number MOP-110993.

    • Competing interests CM has been an adviser for Abbvie, Astellas, Ferring, Janssen and Sanofi; and has participated in clinical trials supported by Abbvie. LTL has been an adviser for Ferring and Sanofi; and has received a grant from Sanofi. IC has been an adviser for Abbvie and Ferring; and has received speaker honoraria from Abbvie, Acerus and Ferring. The remaining authors report no competing personal or financial interests.

    • Patient consent Not required.

    • Ethics approval Ethics approval was obtained for all participating study sites: Ottawa Health Science Network Research Ethics Board (The Ottawa Hospital, Ottawa; Protocol ID 2010767–01H); Ontario Cancer Research Ethics Board (University Health Network, Toronto; Protocol ID 12–011); Hamilton Integrated Research Ethics Board (St. Joseph’s Hospital, Hamilton; Protocol ID 12–3779); Comité d’éthique et de la recherche du CHU de Québec-Université Laval (Centre Hospitalier Universitaire (CHU) de Québec, Quebec City; Protocol ID 2012–1040); Western University Health Science Research Ethics Board (London Health Sciences Centre, London; Protocol ID 103164) and Nova Scotia Health Authority Research Ethics Board (Capital District Health Authority, Halifax; Protocol ID 1015028).

    • Provenance and peer review Not commissioned; externally peer reviewed.