Takeshita Kotaro, Hijioka Susumu, Ikezawa Kenji, Ogura Takeshi, Kuwatani Masaki, Fujimori Nao, Doi Shinpei, Endo Masato, Matsubara Saburo, Yamada Reiko, Mashima Hirosato, Kataoka Mikinori, Takada Ryoji, Okuda Atsushi, Ohno Akihisa, Katsukura Nobuhiro, Suzuki Hirosumi, Tanaka Takamitsu, Sekine Masanari, Kitamura Hidetoshi, Okusaka Takuji
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.
Department of Gastroenterology, Tane General Hospital, Osaka, Japan.
Dig Dis Sci. 2025 Apr;70(4):1560-1572. doi: 10.1007/s10620-025-08898-z. Epub 2025 Feb 19.
Although various self-expandable metallic stents (SEMSs) for malignant hilar biliary obstruction (MHBO) have been introduced, the optimal SEMS for MHBO has not yet been established.
This study aimed to evaluate outcomes of the transpapillary placement of an uncovered laser-cut SEMS with an ultra-thin delivery sheath (YABUSAME) for MHBO.
This multicenter, prospective study was conducted in 11 hospitals for 10 months (from March 2022 to December 2022). The primary outcome was the stent patency rate at 6 months. Key secondary outcomes were the technical success rate, clinical success rate, time to recurrent biliary obstruction (RBO), overall survival (OS), and adverse events.
Of 45 enrolled patients, 43 patients underwent biliary drainage, including 42 patients who underwent YABUSAME placement; 66.7% of patients received chemotherapy, and 60% had previously undergone biliary drainage. Drainage methods were partial stent-in-stent, side-by-side, and unilateral in 65.1%, 7.0%, and 27.9% of patients, respectively. Technical and clinical success rates were 93.2% (41/45) and 79.1% (34/45), respectively. The incidence rate of early postprocedural adverse events was 2.2%. The stent patency rate at 6 months was 55.3%. The median time to RBO was 231 days. The median OS was 125 days.
This study showed that the primary outcome, the 6-month stent patency rate, exceeded the expected rate of 55%, which indicates the efficacy of YABUSAME placement for MHBO.
尽管已推出多种用于恶性肝门部胆管梗阻（MHBO）的自膨式金属支架（SEMS），但尚未确定适用于MHBO的最佳SEMS。
本研究旨在评估经乳头置入带有超薄输送鞘的无覆膜激光切割SEMS（YABUSAME）治疗MHBO的效果。
本多中心前瞻性研究在11家医院进行，为期10个月（从2022年3月至2022年12月）。主要结局是6个月时的支架通畅率。关键次要结局是技术成功率、临床成功率、复发性胆管梗阻（RBO）时间、总生存期（OS）和不良事件。
45例入组患者中，43例接受了胆管引流，其中42例接受了YABUSAME置入；66.7%的患者接受了化疗，60%的患者先前接受过胆管引流。引流方式分别为部分支架套叠、并排和单侧，分别占患者的65.1%、7.0%和27.9%。技术成功率和临床成功率分别为93.2%（41/45）和79.1%（34/45）。术后早期不良事件发生率为2.2%。6个月时的支架通畅率为55.3%。RBO的中位时间为231天。中位OS为125天。
本研究表明，主要结局即6个月时支架通畅率超过了预期的55%，这表明YABUSAME置入治疗MHBO有效。
