带静脉切除和重建的机器人胰十二指肠切除术与开腹胰十二指肠切除术:倾向评分匹配分析

N. Napoli, E. Kauffmann, M. Ginesini, Armando Di Dato, V. Viti, Cesare Gianfaldoni, Lucrezia Lami, C. Cappelli, Maria Isabella Rotondo, D. Campani, G. Amorese, C. Vivaldi, Silvia Cesario, Laura Bernardini, Enrico Vasile, F. Vistoli, U. Boggi
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引用次数: 0

摘要

本研究旨在根据术后严重并发症(SPC)的发生率对机器人胰十二指肠切除术和静脉切除术(PD-VR)进行比较。 机器人胰十二指肠切除术近年来发展势头良好。这种手术经常需要进行静脉切除,但目前还没有研究采用匹配分析法对机器人胰十二指肠切除术和开放式胰十二指肠切除术进行比较。 这是一项意向治疗研究,旨在证明基于SPC的机器人PD-VR与开放式PD-VR(2011-2021年)的非劣效性。为了达到80%的功率(非劣效差:10%;α误差:0.05;ß误差:0.20),需要对35对患者进行1:1倾向得分匹配分析。 在151名PD-VR患者中(开放手术=115例,机器人手术=36例),每组比较了35例手术。1 名机器人 PD-VR 患者(2.9%)需要选择转为开放手术。两组中均有一名患者出现部分静脉血栓。机器人 PD-VR 组和开放 PD-VR 组分别有 7 名(20.0%)和 6 名(17.1%)患者发生 SPC(P = 0.759;OR:1.21 [0.36-4.04])。机器人 PD-VR 术后有 3 名患者死亡(8.6%),而开放式 PD-VR 术后没有患者死亡(P = 0.239)。机器人 PD-VR 需要更长的手术时间(611.1 ± 13.9 分钟 vs 529.0 ± 13.0 分钟;P < 0.0001)、更多的 2 型静脉切除(28.6% vs 5.7%;P = 0.0234)和更少的 3 型静脉切除(31.4% vs 71.4%;P = 0.0008)、更长的静脉闭塞时间(30 [25.3-78.3] 分钟 vs 15 [8-19.5] 分钟;P = 0.0098),失血更少(450 [200-750] mL vs 733 [500-1070.3] mL;P = 0.0075),输血更少(术中:14.3% vs 48.6%;P = 0.0041)(围手术期:14.3% vs 60.0%;P = 0.0001)。 在这项研究中,在 SPC 方面,机器人 PD-VR 并不比开腹 PD-VR 差。机器人和开放式PD-VR需要在随机对照试验中进行比较。
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Robotic Versus Open Pancreatoduodenectomy With Vein Resection and Reconstruction: A Propensity Score-Matched Analysis
This study aimed to compare robotic pancreatoduodenectomy with vein resection (PD-VR) based on the incidence of severe postoperative complications (SPC). Robotic pancreatoduodenectomy has been gaining momentum in recent years. Vein resection is frequently required in this operation, but no study has compared robotic and open PD-VR using a matched analysis. This was an intention-to-treat study designed to demonstrate the noninferiority of robotic to open PD-VR (2011–2021) based on SPC. To achieve a power of 80% (noninferiority margin:10%; α error: 0.05; ß error: 0.20), a 1:1 propensity score-matched analysis required 35 pairs. Of the 151 patients with PD-VR (open = 115, robotic = 36), 35 procedures per group were compared. Elective conversion to open surgery was required in 1 patient with robotic PD-VR (2.9%). One patient in both groups experienced partial vein thrombosis. SPC occurred in 7 (20.0%) and 6 patients (17.1%) in the robotic and open PD-VR groups, respectively (P = 0.759; OR: 1.21 [0.36–4.04]). Three patients died after robotic PD-VR (8.6%) and none died after open PD-VR (P = 0.239). Robotic PD-VR was associated with longer operative time (611.1 ± 13.9 minutes vs 529.0 ± 13.0 minutes; P < 0.0001), more type 2 vein resection (28.6% vs 5.7%; P = 0.0234) and less type 3 vein resection (31.4% vs 71.4%; P = 0.0008), longer vein occlusion time (30 [25.3–78.3] minutes vs 15 [8–19.5] minutes; P = 0.0098), less blood loss (450 [200–750] mL vs 733 [500–1070.3] mL; P = 0.0075), and fewer blood transfusions (intraoperative: 14.3% vs 48.6%; P = 0.0041) (perioperative: 14.3% vs 60.0%; P = 0.0001). In this study, robotic PD-VR was noninferior to open PD-VR for SPC. Robotic and open PD-VR need to be compared in randomized controlled trials.
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