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用于开放和机器人辅助肾移植的冷缺血设备的逐步开发。

Step-by-step Development of a Cold Ischemia Device for Open and Robotic-assisted Renal Transplantation.

机构信息

Department of Urology, Fundació Puigvert, Autonoma University of Barcelona, Spain.

Department of Urology, Fundació Puigvert, Autonoma University of Barcelona, Spain.

出版信息

Eur Urol. 2021 Dec;80(6):738-745. doi: 10.1016/j.eururo.2021.05.026. Epub 2021 May 28.

DOI:10.1016/j.eururo.2021.05.026
PMID:34059396
Abstract

BACKGROUND

Kidney transplantation (KT) is the best renal replacement treatment. The rewarming time is associated with ischemia/reperfusion damage. In both the open (open KT [OKT]) and the robotic (robotic-assisted KT [RAKT]) approaches, ice slush is used to maintain graft temperature (T°) below 20 °C. This may result in nonhomogeneous graft T° maintenance and, particularly during RAKT where the graft is completely inside the abdominal cavity, rises concerns regarding systemic hypothermia.

OBJECTIVE

To design a cold ischemia device (CID) to maintain a constant and homogeneous low graft T° during surgery.

DESIGN, SETTING, AND PARTICIPANTS: In IDEAL phase 0, a CID was developed and tested to determine its cooling effect on the kidney inside a closed system at 37.5 °C, by comparing it with kidney alone versus a gauze-jacket filled with ice slush. The CID was evaluated in pigs undergoing OKT and RAKT, assessing feasibility and adverse reactions. In IDEAL phase 1, the CID was tested in human OKT and RAKT.

SURGICAL PROCEDURE

OKT and RAKT.

MEASUREMENTS

In all phases, T° was evaluated at scheduled time points.

RESULTS AND LIMITATIONS

In the preliminary tests of IDEAL phase 0, the CID was able to maintain a low graft T° and superiority to other groups (p =  0.002). In the in vivo animal model, the CID maintained a low and constant graft T° in OKT (n = 3) and RAKT (n = 3), with a mean T° at 50 min of 10.8 °C and 14.9 °C, respectively. IDEAL phase 1 demonstrated feasibility of both approaches (OKT, n = 2 and RAKT, n = 3) using the CID, and graft T° never exceeded 20 °C (mean T°: OKT 15.7 °C vs RAKT 18.3 °C). No complications were recorded. The main limitation consists in the low number of participants.

CONCLUSIONS

The CID assured a constant low graft T° during rewarming time, in both OKT and RAKT.

PATIENT SUMMARY

A cold ischemia device (CID) is the first step toward a feasible, safe, and reproducible method to maintain a low graft temperature during surgery. The employment of a CID may optimize the functional outcomes.

摘要

背景

肾移植(KT)是最佳的肾脏替代治疗方法。复温时间与缺血/再灌注损伤有关。在开放(开放肾移植 [OKT])和机器人辅助(机器人辅助肾移植 [RAKT])方法中,使用冰泥来维持移植物温度(T°)低于 20°C。这可能导致移植物 T°维持不均匀,特别是在 RAKT 中,移植物完全在腹腔内,这引起了对全身低体温的关注。

目的

设计一种冷缺血装置(CID),以在手术过程中保持恒定且均匀的低移植物 T°。

设计、设置和参与者:在 IDEAL 阶段 0 中,开发了一种 CID 并进行了测试,以通过将其与单独的肾脏与充满冰泥的纱布套进行比较,确定其在 37.5°C 下对封闭系统中肾脏的冷却效果。在接受 OKT 和 RAKT 的猪中评估了 CID,评估了其可行性和不良反应。在 IDEAL 阶段 1 中,在人类 OKT 和 RAKT 中测试了 CID。

手术程序

OKT 和 RAKT。

测量

在所有阶段,均按计划时间点评估 T°。

结果和局限性

在 IDEAL 阶段 0 的初步测试中,CID 能够维持低移植物 T°并优于其他组(p=0.002)。在体内动物模型中,CID 在 OKT(n=3)和 RAKT(n=3)中维持低而恒定的移植物 T°,50 分钟时的平均 T°分别为 10.8°C 和 14.9°C。IDEAL 阶段 1 证明了两种方法(OKT,n=2 和 RAKT,n=3)使用 CID 的可行性,并且移植物 T°从未超过 20°C(平均 T°:OKT 15.7°C 与 RAKT 18.3°C)。未记录到并发症。主要限制在于参与者人数较少。

结论

CID 在 OKT 和 RAKT 中确保了复温过程中恒定的低移植物 T°。

患者总结

冷缺血装置(CID)是实现低手术期间维持移植物温度的可行、安全和可重复方法的第一步。CID 的使用可能会优化功能结果。

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