Nakaoka Kazunori, Hashimoto Senju, Kawabe Naoto, Nakano Takuji, Kan Toshiki, Ohki Masashi, Ochi Yuka, Takamura Tomoki, Kurashita Takamitsu, Nomura Sayuri, Koyama Keishi, Fukui Aiko, Yoshioka Kentaro
Department of Liver, Biliary Tract and Pancreas Diseases, Fujita Health University School of Medicine, Aichi, Japan.
Endosc Int Open. 2018 Oct;6(10):E1164-E1170. doi: 10.1055/a-0627-7078. Epub 2018 Oct 8.
Biliary metallic stents are used to drain unresectable malignant distal biliary obstructions. This study aimed to evaluate the efficacy of a novel 12-mm-diameter covered, self-expandable end bare metal stent (12-mm CSEEMS). We evaluated 99 patients with unresectable malignant distal biliary obstructions treated with covered biliary metallic stents. Of the 99 patients, 33 underwent 12-mm CSEEMS placement between June 2015 and April 2017 (12-mm-CSEEMS group) and 66 underwent 10-mm fully-covered self-expandable metal stent (FCSEMS) placement between January 2010 and July 2015 (10-mm-FCSEMS group). The overall survival (OS), the recurrent biliary obstruction (RBO), cause of RBO, time to RBO (TRBO) and adverse events in 12-mm-CSEEMS group and 10-mm-FCSEMS group were evaluated retrospectively. The OS tended to be longer in the 12-mm-CSEEMS group (log rank, = 0.081) and TRBO was significantly longer in the 12-mm-CSEEMS group (log rank, = 0.001) than in the 10-mm-FCSEMS group. Both univariate (HR, 0.449; 95 % CI, 0.27967 - 0.72215; = 0.001) and multivariate (HR, 0.458; 95 % CI, 0.28395 - 0.73744; = 0.001) Cox hazard analysis found that risk of RBO was significantly lower in 12-mm CSEEMS than in 10-mm FCSEMS. There were no significant differences between the 12-mm-CSEEMS group and 10-mm-FCSEMS group regarding the cause of RBO and adverse events. The 12-mm CSEEMS showed a low risk of RBO compared with 10-mm FCSEMS and was considered to be effective and safe for draining unresectable malignant distal biliary obstruction.
胆道金属支架用于引流无法切除的恶性远端胆道梗阻。本研究旨在评估一种新型直径12毫米的覆膜自膨式裸金属支架（12毫米CSEEMS）的疗效。我们评估了99例接受覆膜胆道金属支架治疗的无法切除的恶性远端胆道梗阻患者。在这99例患者中，33例于2015年6月至2017年4月期间置入12毫米CSEEMS（12毫米CSEEMS组），66例于2010年1月至2015年7月期间置入10毫米全覆膜自膨式金属支架（FCSEMS）（10毫米FCSEMS组）。对12毫米CSEEMS组和10毫米FCSEMS组的总生存期（OS）、复发性胆道梗阻（RBO）、RBO原因、RBO发生时间（TRBO）及不良事件进行回顾性评估。12毫米CSEEMS组的OS有延长趋势（对数秩检验，P = 0.081），且12毫米CSEEMS组的TRBO明显长于10毫米FCSEMS组（对数秩检验，P = 0.001）。单因素（HR，0.449；95%CI，0.27967 - 0.72215；P = 0.001）和多因素（HR，0.458；95%CI，0.28395 - 0.73744；P = 0.001）Cox风险分析均发现，12毫米CSEEMS的RBO风险显著低于10毫米FCSEMS。12毫米CSEEMS组和10毫米FCSEMS组在RBO原因及不良事件方面无显著差异。与10毫米FCSEMS相比，12毫米CSEEMS显示出较低的RBO风险，被认为对于引流无法切除的恶性远端胆道梗阻有效且安全。
