非阻断机器人辅助部分肾切除术对肾功能有益吗？来自CLOCK试验的数据。

Is off-clamp robot-assisted partial nephrectomy beneficial for renal function? Data from the CLOCK trial.

作者信息

Antonelli Alessandro, Cindolo Luca, Sandri Marco, Veccia Alessandro, Annino Filippo, Bertagna Francesco, Carini Marco, Celia Antonio, D'Orta Carlo, De Concilio Bernardino, Furlan Maria, Giommoni Valentina, Ingrosso Manuela, Mari Andrea, Nucciotti Roberto, Olianti Catia, Porreca Angelo, Primiceri Giulia, Schips Luigi, Sessa Francesco, Bove Pierluigi, Simeone Claudio, Minervini Andrea

机构信息

Urology Unit ASST Spedali Civili Hospital, University of Brescia, Brescia, Italy.

Urology Unit AUOI Verona, University of Verona, Verona, Italy.

出版信息

BJU Int. 2022 Feb;129(2):217-224. doi: 10.1111/bju.15503. Epub 2021 Jul 4.

DOI:10.1111/bju.15503

PMID:34086393

Abstract

OBJECTIVES

To compare the functional outcomes of on- vs off-clamp robot-assisted partial nephrectomy (RAPN) within a randomized controlled trial (RCT).

MATERIALS AND METHODS

The CLOCK study (CLamp vs Off Clamp the Kidney during robotic partial nephrectomy; NCT02287987) is a multicentre RCT including patients with normal baseline function, two kidneys and masses with RENAL scores ≤ 10. Pre- and postoperative renal scintigraphy was prescribed. Renal defatting and hilum isolation were required in both study arms; in the on-clamp arm, ischaemia was imposed until the completion of medullary renorraphy, while in the off-clamp condition it was not allowed throughout the procedure. The primary endpoint was 6-month absolute variation in estimated glomerular filtration rate (AV-GFR); secondary endpoints were: 12, 18 and 24-month AV-GFR; 6-month estimated glomerular filtration rate variation >25% rate (RV-GFR >25); and absolute variation in ipsilateral split renal function (AV-SRF). The planned sample size was 102 + 102 cases, after taking account crossover of cases to the alternate study arm; a 1:1 randomization was performed. AV-GFR and AV-SRF were compared using analysis of covariation, and RV-GFR >25 was assessed using multivariable logistic regression. Intention-to-treat (ITT) and per-protocol analyses (PP) were performed.

RESULTS

A total of 160 and 164 patients were randomly assigned to on- and off-clamp RAPN, respectively; crossover was observed in 14% and 43% of the on- and off-clamp arms, respectively. We were unable to find any statistically significant difference between on- vs off-clamp with regard to the primary endpoint (ITT: 6-month AV-GFR -6.2 vs -5.1 mL/min, mean difference 0.2 mL/min, 95% confidence interval [CI] -3.1 to 3.4 [P = 0.8]; PP: 6-month AV-GFR -6.8 vs -4.2 mL/min, mean difference 1.6 mL/min, 95% CI -2.3 to 5.5 [P = 0.7]) or with regard to the secondary endpoints. The median warm ischaemia time was 14 vs 15 min in the ITT analysis and 14 vs 0 min in the PP analysis.

CONCLUSION

In patients with regular baseline function and two kidneys, we found no evidence of differences in functional outcomes for on- vs off-clamp RAPN.

摘要

目的

在一项随机对照试验（RCT）中比较夹闭与非夹闭机器人辅助部分肾切除术（RAPN）的功能结局。

材料与方法

CLOCK研究（机器人部分肾切除术中夹闭与非夹闭肾脏；NCT02287987）是一项多中心RCT，纳入基线功能正常、有两个肾脏且RENAL评分≤10的肿块患者。规定进行术前和术后肾闪烁显像。两个研究组均需要进行肾脏去脂和肾蒂分离；在夹闭组，缺血持续至髓质肾缝合完成，而在非夹闭组，整个手术过程中不允许缺血。主要终点是估计肾小球滤过率（AV-GFR）的6个月绝对变化；次要终点是：12、18和24个月的AV-GFR；6个月估计肾小球滤过率变化>25%的发生率（RV-GFR>25）；以及患侧分肾功能的绝对变化（AV-SRF）。考虑到病例交叉至另一研究组后，计划样本量为102 + 102例；进行1:1随机分组。使用协方差分析比较AV-GFR和AV-SRF，使用多变量逻辑回归评估RV-GFR>25。进行意向性分析（ITT）和符合方案分析（PP）。

结果

分别有160例和164例患者被随机分配至夹闭和非夹闭RAPN组；夹闭组和非夹闭组分别有14%和43%的患者出现交叉。我们未能发现夹闭与非夹闭在主要终点方面有任何统计学显著差异（ITT：6个月AV-GFR -6.2 vs -5.1 mL/min，平均差异0.2 mL/min，95%置信区间[CI] -3.1至3.4 [P = 0.8]；PP：6个月AV-GFR -6.8 vs -4.2 mL/min，平均差异1.6 mL/min，95% CI -2.3至5.5 [P = 0.7]），在次要终点方面也无差异。ITT分析中，中位热缺血时间为14 vs 15分钟，PP分析中为14 vs 0分钟。