Imamura Naoya, Nanashima Atsushi, Tsuchimochi Yuki, Hamada Takeomi, Kawakami Hiroshi, Hiyoshi Masahide
Division of Hepato-Biliary-Pancreas Surgery, Department of Surgery, University of Miyazaki Faculty of Medicine, Miyazaki, Japan.
Division of Gastroenterology and Hepatology, Department of Internal Medicine, University of Miyazaki Faculty of Medicine, Miyazaki, Japan.
Gland Surg. 2025 Apr 30;14(4):714-725. doi: 10.21037/gs-2024-507. Epub 2025 Apr 24.
Neoadjuvant chemotherapy (NAC) has been increasingly used in recent years in patients with pancreatic ductal adenocarcinoma (PDAC). This has forced a change in the practice of preoperative biliary drainage (PBD) is performed in PDAC patients scheduled for pancreatoduodenectomy (PD). What has changed in the NAC era and what is the appropriate method of PBD? To address this question, this study retrospectively reviewed the surgical outcomes and details of PBD in NAC and upfront surgery (US) patients.
The study included consecutive PDAC patients who underwent PD from 2013 to 2021 during the transition from US to NAC, when outcomes were comparable. Clinical factors such as patient background, preoperative examination, surgical procedure, and postoperative complications were compared between the NAC group (40 patients) and the US group (59 patients), and details of PBD such as PBD procedure and adverse events were compared between the NAC and US groups who received PBD (27 NAC patients, 33 US patients). In the comparison test between groups, Fisher's exact test and Mann-Whitney test were mainly used. In addition, the outcomes and patency periods of each of the 128 PBD procedures were examined for the 60 patients who underwent PBD. The log-rank test was performed using the Kaplan-Meier method to compare patency period by PBD procedure.
There were no differences in patient background between the NAC and US groups. Compared with the US group, the NAC group had higher preoperative albumin (ALB) levels and less blood loss, but there was no difference of postoperative complications (NAC US, 35% 46%, respectively, P=0.29). With respect to PBD, the NAC group had more initial metallic stent (MS) placement (NAC US, 52% 15%, respectively, P=0.009), and fewer PBD-related adverse events (NAC US, 33% 61%, respectively, P=0.04). In a comparison of outcomes by drainage method, the duration of patency was significantly longer with MS placement than plastic stent (PS) placement (median days of patency, MS PS, 68 15 days, respectively, P<0.001). However, MS placement and PS placement were equally likely to require a delay in the surgical schedule due to PBD-related adverse events (MS PS, 6% 6%, respectively, P>0.99).
Prolonged PBD with NAC did not adversely affect surgical outcomes. MS placement provides a long patency period and is currently useful in PBD for PDAC patients undergoing PD after NAC, which requires a prolonged preoperative period. However, MS placement also has adverse events, and further studies are needed.
近年来,新辅助化疗(NAC)在胰腺导管腺癌(PDAC)患者中应用越来越广泛。这促使了对计划接受胰十二指肠切除术(PD)的PDAC患者进行术前胆道引流(PBD)的实践发生改变。在NAC时代有哪些变化,以及合适的PBD方法是什么?为解决这个问题,本研究回顾性分析了NAC组和直接手术(US)组患者的手术结局及PBD细节。
本研究纳入了2013年至2021年期间从US过渡到NAC且结局可比的连续接受PD的PDAC患者。比较了NAC组(40例患者)和US组(59例患者)的患者背景、术前检查、手术操作及术后并发症等临床因素,还比较了接受PBD的NAC组(27例患者)和US组(33例患者)的PBD细节,如PBD操作及不良事件。在组间比较测试中,主要使用Fisher精确检验和Mann-Whitney检验。此外,对60例行PBD的患者的128次PBD操作的结局及通畅期进行了检查。采用Kaplan-Meier法进行对数秩检验以比较不同PBD操作的通畅期。
NAC组和US组患者背景无差异。与US组相比,NAC组术前白蛋白(ALB)水平较高,失血量较少,但术后并发症无差异(NAC组和US组分别为35%和46%,P = 0.29)。关于PBD,NAC组初始金属支架(MS)置入更多(NAC组和US组分别为52%和15%,P = 0.009),PBD相关不良事件更少(NAC组和US组分别为33%和61%,P = 0.04)。在按引流方法比较结局时,MS置入的通畅持续时间显著长于塑料支架(PS)置入(通畅中位天数,MS组和PS组分别为68天和15天,P < 0.001)。然而,由于PBD相关不良事件,MS置入和PS置入导致手术日程延迟的可能性相同(MS组和PS组均为6%,P > 0.99)。
NAC下延长的PBD对手术结局无不利影响。MS置入提供了较长的通畅期,目前对接受NAC后行PD的PDAC患者的PBD有用,这类患者术前需要较长时间。然而,MS置入也有不良事件,需要进一步研究。