微创与开腹胰十二指肠切除术治疗胰导管腺癌的比较：随机试验的个体患者数据分析荟萃分析。
Minimally invasive versus open pancreatoduodenectomy for pancreatic ductal adenocarcinoma: Individual patient data meta-analysis of randomized trials.
机构信息
Department of Surgery, Fondazione Poliambulanza, Brescia, Italy; Amsterdam UMC, Location University of Amsterdam, Department of Surgery, Amsterdam, the Netherlands; Cancer Center Amsterdam, the Netherlands.
Faculty of Hepato-Biliary-Pancreatic Surgery, The First Medical Center of Chinese People's Liberation Army (PLA) General Hospital, Beijing, China; Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.
出版信息
Eur J Surg Oncol. 2023 Aug;49(8):1351-1361. doi: 10.1016/j.ejso.2023.03.227. Epub 2023 Apr 7.
OBJECTIVE
Assessment of minimally invasive pancreatoduodenectomy (MIPD) in patients with pancreatic ductal adenocarcinoma (PDAC) is scarce and limited to non-randomized studies. This study aimed to compare oncological and surgical outcomes after MIPD compared to open pancreatoduodenectomy (OPD) for patients after resectable PDAC from published randomized controlled trials (RCTs).
METHODS
A systematic review was performed to identify RCTs comparing MIPD and OPD including PDAC (Jan 2015-July 2021). Individual data of patients with PDAC were requested. Primary outcomes were R0 rate and lymph node yield. Secondary outcomes were blood-loss, operation time, major complications, hospital stay and 90-day mortality.
RESULTS
Overall, 4 RCTs (all addressed laparoscopic MIPD) with 275 patients with PDAC were included. In total, 128 patients underwent laparoscopic MIPD and 147 patients underwent OPD. The R0 rate (risk difference(RD) -1%, P = 0.740) and lymph node yield (mean difference(MD) +1.55, P = 0.305) were comparable between laparoscopic MIPD and OPD. Laparoscopic MIPD was associated with less perioperative blood-loss (MD -91ml, P = 0.026), shorter length of hospital stay (MD -3.8 days, P = 0.044), while operation time was longer (MD +98.5 min, P = 0.003). Major complications (RD -11%, P = 0.302) and 90-day mortality (RD -2%, P = 0.328) were comparable between laparoscopic MIPD and OPD.
CONCLUSIONS
This individual patient data meta-analysis of MIPD versus OPD in patients with resectable PDAC suggests that laparoscopic MIPD is non-inferior regarding radicality, lymph node yield, major complications and 90-day mortality and is associated with less blood loss, shorter hospital stay, and longer operation time. The impact on long-term survival and recurrence should be studied in RCTs including robotic MIPD.
目的
评估微创胰十二指肠切除术（MIPD）在胰腺导管腺癌（PDAC）患者中的应用，相关研究很少且仅限于非随机研究。本研究旨在比较可切除 PDAC 患者接受 MIPD 与开放胰十二指肠切除术（OPD）后的肿瘤学和手术结果，研究纳入了已发表的随机对照试验（RCT）。
方法
系统检索了 2015 年 1 月至 2021 年 7 月期间比较 MIPD 和 OPD 治疗 PDAC 的 RCT 研究，并请求提供 PDAC 患者的个体数据。主要结局为 R0 切除率和淋巴结检出数。次要结局为出血量、手术时间、主要并发症、住院时间和 90 天死亡率。
结果
共纳入 4 项 RCT（均为腹腔镜 MIPD），共计 275 例 PDAC 患者。其中，128 例患者接受腹腔镜 MIPD，147 例患者接受 OPD。腹腔镜 MIPD 与 OPD 的 R0 切除率（风险差（RD）-1%，P=0.740）和淋巴结检出数（均数差（MD）+1.55，P=0.305）相当。腹腔镜 MIPD 围手术期出血量较少（MD-91ml，P=0.026），住院时间较短（MD-3.8 天，P=0.044），但手术时间较长（MD+98.5 分钟，P=0.003）。腹腔镜 MIPD 与 OPD 的主要并发症（RD-11%，P=0.302）和 90 天死亡率（RD-2%，P=0.328）相当。
结论
本研究对可切除 PDAC 患者接受 MIPD 与 OPD 的个体患者数据进行了荟萃分析，结果表明，腹腔镜 MIPD 在根治性、淋巴结检出数、主要并发症和 90 天死亡率方面不劣于 OPD，且出血量较少、住院时间较短、手术时间较长。应在包括机器人 MIPD 的 RCT 中研究其对长期生存和复发的影响。
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