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

Rodney H Breau, Ilias Cagiannos, Greg Knoll, Christopher Morash, Sonya Cnossen, Luke T Lavallée, Ranjeeta Mallick, Antonio Finelli, Michael Jewett, Bradley C Leibovich, Jonathan Cook, Louise LeBel, Anil Kapoor, Frederic Pouliot, Jonathan Izawa, Ricardo Rendon, Dean A Fergusson, Rodney H Breau, Ilias Cagiannos, Greg Knoll, Christopher Morash, Sonya Cnossen, Luke T Lavallée, Ranjeeta Mallick, Antonio Finelli, Michael Jewett, Bradley C Leibovich, Jonathan Cook, Louise LeBel, Anil Kapoor, Frederic Pouliot, Jonathan Izawa, Ricardo Rendon, Dean A Fergusson

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.

Keywords: cold ischemia; kidney cancer; partial nephrectomy; renal function; renal hypothermia.

Conflict of interest statement

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.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Study flow chart. GFR, glomerular filtration rate.

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