Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, the Netherlands.
Department of Surgery, OLVG, Amsterdam, the Netherlands.
Ann Surg. 2022 Dec 1;276(6):e886-e895. doi: 10.1097/SLA.0000000000004783. Epub 2021 Feb 1.
To assess feasibility and safety of a multicenter training program in robotic pancreatoduodenectomy (RPD) adhering to the IDEAL framework for implementation of surgical innovation.
Good results for RPD have been reported from single center studies. However, data on feasibility and safety of implementation through a multicenter training program in RPD are lacking.
A multicenter training program in RPD was designed together with the University of Pittsburgh Medical Center, including an online video bank, robot simulation exercises, biotissue drills, and on-site proctoring. Benchmark patients were based on the criteria of Clavien. Outcomes were collected prospectively (March 2016-October 2019). Cumulative sum analysis of operative time was performed to distinguish the first and second phase of the learning curve. Outcomes were compared between both phases of the learning curve. Trends in nationwide use of robotic and laparoscopic PD were assessed in the Dutch Pancreatic Cancer Audit.
Overall, 275 RPD procedures were performed in seven centers by 15 trained surgeons. The recent benchmark criteria for low-risk PD were met by 125 (45.5%) patients. The conversion rate was 6.5% (n = 18) and median blood loss 250ml [interquartile range (IQR) 150-500]. The rate of Clavien-Dindo grade ≥III complications was 44.4% (n = 122), postoperative pancreatic fistula (grade B/C) rate 23.6% (n = 65), 90-day complication-related mortality 2.5% (n = 7) and 90-day cancer-related mortality 2.2.% (n = 6). Median postoperative hospital stay was 12 days (IQR 8-20). In the subgroup of patients with pancreatic cancer (n = 80), the major complication rate was 31.3% and POPF rate was 10%. Cumulative sum analysis for operative time found a learning curve inflection point at 22 RPDs (IQR 10-35) with similar rates of Clavien-Dindo grade ≥III complications in the first and second phase (43.4% vs 43.8%, P = 0.956, respectively). During the study period the nationwide use of laparoscopic PD reduced from 15% to 1%, whereas the use of RPD increased from 0% to 25%.
This multicenter RPD training program in centers with sufficient surgical volume was found to be feasible without a negative impact of the learning curve on clinical outcomes.
根据 IDEAL 框架评估机器人胰十二指肠切除术（RPD）多中心培训计划的可行性和安全性，以实施外科创新。
单中心研究报告了 RPD 的良好结果。然而，缺乏通过 RPD 多中心培训计划实施的可行性和安全性数据。
与匹兹堡大学医学中心一起设计了 RPD 的多中心培训计划，包括在线视频库、机器人模拟练习、生物组织钻和现场监督。基准患者基于 Clavien 的标准。结果前瞻性收集（2016 年 3 月至 2019 年 10 月）。进行累积和分析以区分手术时间学习曲线的第一和第二阶段。比较学习曲线的两个阶段的结果。评估荷兰胰腺癌症审计中的全国范围内使用机器人和腹腔镜 PD 的趋势。
总体而言，7 个中心的 15 名经过培训的外科医生进行了 275 例 RPD 手术。最近的低风险 PD 基准标准适用于 125 名（45.5%）患者。转化率为 6.5%（n = 18），中位失血量为 250ml[四分位距（IQR）150-500]。Clavien-Dindo 分级≥III 级并发症的发生率为 44.4%（n = 122），术后胰瘘（B/C 级）发生率为 23.6%（n = 65），90 天并发症相关死亡率为 2.5%（n = 7）和 90 天癌症相关死亡率为 2.2%（n = 6）。术后中位住院时间为 12 天（IQR 8-20）。在胰腺癌症患者亚组（n = 80）中，主要并发症发生率为 31.3%，POPF 发生率为 10%。手术时间累积和分析发现，学习曲线在 22 例 RPD 处出现拐点（IQR 10-35），第一和第二阶段的 Clavien-Dindo 分级≥III 级并发症发生率相似（分别为 43.4%和 43.8%，P=0.956）。在研究期间，全国范围内腹腔镜 PD 的使用从 15%降至 1%，而 RPD 的使用从 0%增加到 25%。
在具有足够手术量的中心进行的多中心 RPD 培训计划被发现是可行的，学习曲线对临床结果没有负面影响。
