机器人辅助肾部分切除术夹闭与不夹闭的安全性：来自 CLOCK 随机试验数据的方案预设分析。

Safety of on- vs off-clamp robotic partial nephrectomy: per-protocol analysis from the data of the CLOCK randomized trial.

机构信息

Urology Unit, ASST Spedali Civili Hospital and Department of Medical and Surgical Specialties, Radiological Science, and Public Health, University of Brescia, Brescia, Italy.

Urology Unit, D'Annunzio Hospital, University of Chieti, Chieti, Italy.

出版信息

World J Urol. 2020 May;38(5):1101-1108. doi: 10.1007/s00345-019-02879-4. Epub 2019 Jul 24.

DOI:10.1007/s00345-019-02879-4

PMID:31342246

Abstract

PURPOSE

To compare the safety of on- vs off-clamp robotic partial nephrectomy (RAPN).

METHODS

302 patients with RENAL masses ≤ 10 were randomized to undergo on-clamp (150) vs off-clamp (152) RAPN (CLOCK trial-ClinicalTrials.gov NCT02287987) at seven institutions by one experienced surgeon per institution. Intra-operative data, complications, and positive surgical margins were compared.

RESULTS

Due to a relevant rate of shift from the assigned treatment, the per-protocol analysis only was considered and the data from 129 on-clamp vs 91 off-clamp RAPNs analyzed. Tumor size (off-clamp vs on-clamp, 2.2 vs 3.0 cm, p < 0.001) and RENAL score (5 vs 6, p < 0.001) significantly differed. At univariate analysis, no differences were found regarding intra-operative estimated blood loss (off- vs on-clamp, 100 vs 100 ml, p = 0.7), post-operative complications rate (19% vs 26%, p = 0.2), post-operative anemia (Hb decrease > 2.5 g/dl 26% vs 27%, p = 0.9; transfusion rate 3.4% vs 6.3%, p = 0.5; re-intervention due to bleeding 1.1% vs 4%, p = 0.4), acute kidney injury (4% vs 6%, p = 0.8), and positive surgical margins (3.5% vs 8.2%, p = 0.1). At multivariate analysis accounting for tumor diameter and complexity, considering the on-clamp group as the reference category, a significant difference was noted in the off-clamp group exclusively for blood loss (OR 0.3, 95% CI 0.09-0.52, p = 0.008).

CONCLUSIONS

The on-clamp and off-clamp approaches for RAPN showed a comparable safety profile.

摘要

目的

比较夹闭与非夹闭机器人辅助部分肾切除术（RAPN）的安全性。

方法

在 7 家机构中，由 1 名经验丰富的外科医生对 302 名 RENAL 肿块≤10 的患者进行随机分组，分别接受夹闭（150 例）和非夹闭（152 例）RAPN（CLOCK 试验-ClinicalTrials.gov NCT02287987）。比较术中数据、并发症和阳性切缘。

结果

由于治疗分配的变化率较高，仅考虑了方案分析，分析了 129 例夹闭与 91 例非夹闭 RAPN。肿瘤大小（非夹闭与夹闭，2.2 与 3.0cm，p<0.001）和 RENAL 评分（5 与 6，p<0.001）差异显著。单因素分析显示，术中估计失血量（非夹闭与夹闭，100 与 100ml，p=0.7）、术后并发症发生率（19%与 26%，p=0.2）、术后贫血（Hb 下降>2.5g/dl 26%与 27%，p=0.9；输血率 3.4%与 6.3%，p=0.5；因出血再次干预 1.1%与 4%，p=0.4）、急性肾损伤（4%与 6%，p=0.8）和阳性切缘（3.5%与 8.2%，p=0.1）无差异。多因素分析考虑肿瘤直径和复杂性，以夹闭组为参考类别，仅在非夹闭组中，失血量有显著差异（OR 0.3，95%CI 0.09-0.52，p=0.008）。