Division of Urology, Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada.
Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
BMJ Open. 2019 Jan 3;9(1):e025662. doi: 10.1136/bmjopen-2018-025662.
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).
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 approval was obtained for all participating study sites. Results of the trial will be submitted for publication in a peer-reviewed journal.
NCT01529658; Pre-results.
部分肾切除术是技术可行时治疗非转移性肾肿瘤的标准治疗方法。尽管部分肾切除术的应用越来越广泛，但尚未对导致术后最佳肾功能的术中技术进行严格研究。在切除过程中夹闭肾门以防止出血会导致暂时的肾缺血。在试图减轻缺血影响的同时，肾门夹闭后肾脏内部温度可能会降低（肾低温）。我们的目标是确定与温热缺血（无肾低温）相比，开放性部分肾切除术中的肾低温是否会导致术后 12 个月的肾功能改善。
这是一项多中心、随机、单盲对照试验，比较了开放性部分肾切除术中肾低温与无低温的效果。由于干预的性质，完全对手术团队进行盲法是不可能的；然而，外科医生将在肾门夹闭之前保持盲法。肾小球滤过率将基于放射性核素的血浆清除率，而差异肾功能将基于肾闪烁扫描。主要结局是通过肾小球滤过率（GFR）测量的 12 个月时的整体肾功能。次要结局包括 GFR 的变化、受影响肾脏的 GFR、受影响肾脏的 GFR 变化、血清肌酐、血红蛋白、尿液白蛋白与肌酐比值、生活质量和术后并发症。数据将在基线、术后即刻以及术后 3、6、9 和 12 个月收集。
所有参与研究的地点都获得了伦理批准。试验结果将提交给同行评议的期刊发表。
NCT01529658；预结果。
