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机器人胰十二指肠切除术的学习曲线分层结果:国际多中心经验。

Learning curve stratified outcomes after robotic pancreatoduodenectomy: International multicenter experience.

机构信息

Department of General Surgery, Istituto Ospedaliero Fondazione Poliambulanza, Brescia, Italy; Department of Surgery, Amsterdam UMC, University of Amsterdam, the Netherlands; Cancer Center Amsterdam, the Netherlands.

Department of Surgery, Amsterdam UMC, University of Amsterdam, the Netherlands; Cancer Center Amsterdam, the Netherlands.

出版信息

Surgery. 2024 Dec;176(6):1721-1729. doi: 10.1016/j.surg.2024.05.044. Epub 2024 Aug 19.

DOI:10.1016/j.surg.2024.05.044
PMID:39164152
Abstract

BACKGROUND

Robotic pancreatoduodenectomy is increasingly being implemented worldwide, with good results reported from individual expert centers. However, it is unclear to what extent outcomes will continue to improve during the learning curve, as large international studies are lacking.

METHODS

An international retrospective multicenter case series, including consecutive patients after robotic pancreatoduodenectomy from 18 centers in 8 countries in Europe, Asia, and South America until December 31, 2019, was conducted. A cumulative sum analysis was performed to determine the inflection points for the feasibility (operative time and blood loss) and proficiency (postoperative pancreatic fistula grade B/C and major morbidity) learning curves. Outcomes were compared in 3 groups on the basis of the learning curve inflection points.

RESULTS

Overall, 2,186 patients after robotic pancreatoduodenectomy were included. The feasibility learning curve was reached after 30-45 robotic pancreatoduodenectomy procedures and the proficiency learning curve after 90 robotic pancreatoduodenectomy procedures. These inflection points created 3 phases, which were associated with major morbidity (24.7%, 23.4%, and 12.3%, P < .001) but not 30-day mortality (2.1%, 2.0%, and 1.5%, P = .670). Other outcomes mostly continued to improve, including median operative time 432, 390, and 300 minutes (P < .0001), conversion 6.0%, 4.7%, and 2.7% (P = .002), bile leakage 7.2%, 4.1%, and 2.4% (P < .001), postpancreatectomy hemorrhage 6.5%, 6.1%, and 1.8% (n = 21) but not R0 resection (pancreatic ductal adenocarcinoma only) 78.5%, 73.9%, and 82.8% (P = .35), and 90-day mortality rate 3.1%, 3.5%, and 2.1% (P = .191). Centers performing >20 robotic pancreatoduodenectomies annually had lower rates of conversion, reoperation, and shorter median operative time as compared with centers performing 10-20 robotic pancreatoduodenectomies annually.

CONCLUSION

This international multicenter study demonstrates that most outcomes of robotic pancreatoduodenectomy continued to improve during 3 learning curve phases without a negative effect on 90-day mortality. Randomized studies are needed in high-volume centers that have surpassed the first learning curves, to compare these outcomes with the open approach.

摘要

背景

机器人胰十二指肠切除术在全球范围内的应用日益增多,个别专家中心的报告结果良好。然而,由于缺乏大型国际研究,目前尚不清楚在学习曲线过程中,结果会在多大程度上继续改善。

方法

进行了一项国际性回顾性多中心病例系列研究,纳入了来自欧洲、亚洲和南美洲 8 个国家的 18 个中心的连续患者,他们接受了机器人胰十二指肠切除术,时间截至 2019 年 12 月 31 日。采用累积和分析确定了可行性(手术时间和失血量)和熟练程度(术后胰瘘 B/C 级和主要发病率)学习曲线的拐点。根据学习曲线的拐点,将患者分为 3 组进行比较。

结果

共纳入 2186 例机器人胰十二指肠切除术后患者。手术时间和失血量的可行性学习曲线在 30-45 例机器人胰十二指肠切除术后达到,熟练程度学习曲线在 90 例机器人胰十二指肠切除术后达到。这些拐点创建了 3 个阶段,与主要发病率(24.7%、23.4%和 12.3%,P<0.001)相关,但与 30 天死亡率(2.1%、2.0%和 1.5%,P=0.670)无关。其他结果大多继续改善,包括中位手术时间 432、390 和 300 分钟(P<0.0001)、转化率 6.0%、4.7%和 2.7%(P=0.002)、胆漏 7.2%、4.1%和 2.4%(P<0.001)、胰十二指肠切除术后出血 6.5%、6.1%和 1.8%(n=21)但无 R0 切除(仅胰腺导管腺癌)78.5%、73.9%和 82.8%(P=0.35),90 天死亡率 3.1%、3.5%和 2.1%(P=0.191)。每年进行>20 例机器人胰十二指肠切除术的中心与每年进行 10-20 例机器人胰十二指肠切除术的中心相比,转换率、再次手术率和中位手术时间较低。

结论

这项国际性多中心研究表明,机器人胰十二指肠切除术的大多数结果在 3 个学习曲线阶段继续改善,而不会对 90 天死亡率产生负面影响。需要在已经超过第一个学习曲线的大容量中心进行随机研究,以比较这些结果与开放方法。

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