Yamashige Daiki, Hijioka Susumu, Nagashio Yoshikuni, Maruki Yuta, Fukuda Soma, Yagi Shin, Okamoto Kohei, Hara Hidenobu, Hagiwara Yuya, Agarie Daiki, Takasaki Tetsuro, Ohba Akihiro, Kondo Shunsuke, Morizane Chigusa, Ueno Hideki, Sone Miyuki, Saito Yutaka, Okusaka Takuji
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.
Department of Diagnostic Radiology, National Cancer Center Hospital, Tokyo, Japan.
Clin Endosc. 2025 Jan;58(1):121-133. doi: 10.5946/ce.2024.044. Epub 2024 Jul 29.
BACKGROUND/AIMS: To date, only thinner-diameter metal stents have been evaluated for unresectable malignant distal biliary obstruction (UR-MDBO). This study investigated the outcomes and optimal cohorts for a 6-mm-diameter fully covered self-expandable metal stent (FCSEMS) compared with those for a 10-mm-diameter FCSEMS.
This single-center retrospective cohort study included patients who underwent initial transpapillary metal stenting for UR-MDBO. Propensity score matching (1:1) analysis was performed.
Of 133/68 patients who underwent 6-mm/10-mm-diameter FCSEMS deployment, 59 in each group were selected. The median time to recurrent biliary obstruction was not significantly different between the groups (p=0.46). In contrast, use of the 6-mm-diameter FCSEMS resulted in a significantly reduced incidence of stent-related adverse events (AEs) (p=0.016), especially cholecystitis (p=0.032), and patients aged <70 years were particularly affected by this significant reduction. Among the patients in the end-stage cohort who were unable to continue chemotherapy after FCSEMS deployment, the free rate of stent-related events, including recurrent biliary obstruction and stent-related AEs, was significantly higher in the 6-mm group (p=0.027).
For UR-MDBO, a 6-mm-diameter FCSEMS can be an optimal and safe option in the younger cohort with a relatively high risk of AEs and in the end-stage cohort requiring safer drainage without interference from stent-related events during times of poor prognosis.
背景/目的：迄今为止，仅对较细直径的金属支架用于不可切除的恶性远端胆管梗阻（UR-MDBO）进行了评估。本研究比较了6毫米直径全覆膜自膨式金属支架（FCSEMS）与10毫米直径FCSEMS的治疗效果及最佳适用人群。
这项单中心回顾性队列研究纳入了因UR-MDBO接受初次经乳头金属支架置入术的患者。进行了倾向评分匹配（1:1）分析。
在接受6毫米/10毫米直径FCSEMS置入术的133/68例患者中，每组各选取59例。两组复发性胆管梗阻的中位时间无显著差异（p = 0.46）。相比之下，使用6毫米直径的FCSEMS导致支架相关不良事件（AE）的发生率显著降低（p = 0.016），尤其是胆囊炎（p = 0.032），年龄<70岁的患者受这种显著降低的影响尤为明显。在FCSEMS置入术后无法继续化疗的终末期队列患者中，6毫米组支架相关事件（包括复发性胆管梗阻和支架相关AE）的无事件发生率显著更高（p = 0.027）。
对于UR-MDBO，6毫米直径的FCSEMS对于不良事件风险相对较高的年轻队列以及预后较差时期需要更安全引流且不受支架相关事件干扰的终末期队列而言，可能是一种最佳且安全的选择。
