Division of Urology, Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada.
Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
J Urol. 2021 May;205(5):1303-1309. doi: 10.1097/JU.0000000000001517. Epub 2020 Dec 21.
Surgeons induce renal hypothermia during partial nephrectomy to preserve kidney function, without strong evidence of benefit. This trial examined the effectiveness and safety of renal hypothermia during partial nephrectomy.
We conducted a parallel randomized controlled trial of hypothermia versus no hypothermia (control group) during partial nephrectomy at 6 academic hospitals. Eligible patients had a planned open partial nephrectomy for the treatment of a renal tumor. During surgery, after clamping the renal hilum, patients were randomized to the intervention or control arm in a 1:1 ratio using permuted blocks of variable lengths (2 and 4), stratified by institution, using a computer-based program. Surgeons and study coordinators were masked to treatment allocation until the renal hilum was clamped. Overall glomerular filtration rates were determined before, and 1-year after, surgery. The primary outcome was measured glomerular filtration rate (mGFR) assessed by the plasma clearance of Tc-DTPA. The trial (NCT01529658) was designed with 90% power to detect a minimal clinically important difference in mGFR of 10 ml/minute/1.73 m at a 5% significance level.
Of the 184 patients randomized, hypothermia and control patients had similar baseline mean mGFR (87.1 vs 81.0 ml/minute/1.73 m). One hundred and sixty-one (79 hypothermia, 82 control) were alive with primary outcome data 1 year after surgery. The change in mGFR 1 year after surgery was -6.6 ml/minute/1.73 m in the hypothermia group and -7.8 ml/minute/1.73 m in the control group (mean difference 1.2 ml/minute/1.73 m, 95% CI -3.3 to 5.6). Operated-kidney change in mGFR was similar between groups (-5.8 vs -6.3 ml/minute/1.73 m; mean difference 0.5 ml/minute/1.73 m, 95% CI -2.9 to 3.8). No clinically significant difference in the mGFR was observed when patients were stratified by pre-planned subgroups. Renal hypothermia did not impact the secondary outcomes of surgical complications and patient reported quality of life.
Renal hypothermia during partial nephrectomy does not preserve kidney function in patients with normal or mildly impaired renal function.
外科医生在部分肾切除术中诱导肾脏低温以保护肾功能，但缺乏明确的获益证据。本试验旨在检验部分肾切除术中低温治疗的有效性和安全性。
我们在 6 所学术医院进行了一项平行随机对照试验，比较了低温组与非低温组（对照组）在部分肾切除术中的疗效。纳入标准为计划行开放性部分肾切除术治疗肾肿瘤的患者。手术中，在夹闭肾门后，使用基于计算机的程序，采用变长度（2 和 4 个）区组随机化（区组大小为 1:1），按机构分层，将患者随机分配至干预组或对照组。外科医生和研究协调员在夹闭肾门之前对治疗分配保持盲态，直到夹闭肾门后才揭晓。在手术前和手术后 1 年，使用 Tc-DTPA 血浆清除率评估总体肾小球滤过率（GFR）。主要结局是通过血浆清除率评估的测量肾小球滤过率（mGFR）。该试验（NCT01529658）设计有 90%的效能，以在 5%的显著性水平下检测 mGFR 最小临床有意义的差异 10ml/min/1.73m。
184 例随机患者中，低温组和对照组的平均基线 mGFR 相似（87.1ml/min/1.73m vs 81.0ml/min/1.73m）。术后 1 年，161 例（低温组 79 例，对照组 82 例）患者存活并获得主要结局数据。低温组术后 1 年 mGFR 的变化为-6.6ml/min/1.73m，对照组为-7.8ml/min/1.73m（平均差值 1.2ml/min/1.73m，95%CI-3.3 至 5.6）。两组间手术肾 GFR 的变化相似（-5.8 vs -6.3ml/min/1.73m；平均差值 0.5ml/min/1.73m，95%CI-2.9 至 3.8）。当根据预先计划的亚组对患者进行分层时，未观察到 mGFR 有临床意义的差异。肾低温治疗并未影响手术并发症和患者报告的生活质量等次要结局。
在肾功能正常或轻度受损的患者中，部分肾切除术中的肾脏低温并不能保护肾功能。
