Matsumoto Kengo, Iwasa Kazuhide, Watanabe Asuka, Takiyama Hiroki, Okabe Satoru, Osugi Naoto, Nakamatsu Dai, Yamamoto Masashi, Hayashi Shiro, Fukui Koji, Nishida Tsutomu
Department of Gastroenterology Toyonaka Municipal Hospital Osaka Japan.
Department of Gastroenterology and Internal Medicine Hayashi Clinic Osaka Japan.
DEN Open. 2025 Jun 22;6(1):e70168. doi: 10.1002/deo2.70168. eCollection 2026 Apr.
Covered self-expandable metal stents (SEMS) are the standard for managing unresectable distal malignant biliary obstruction (DMBO), as they prolong the time to recurrent biliary obstruction (TRBO). However, fully covered SEMS (FCSEMS) increases the risk of cholecystitis and pancreatitis. This exploratory study evaluated a novel multihole partially covered SEMS (MHSEMS) designed to reduce these risks.
The clinical data of 26 DMBO patients treated with MHSEMSs were retrospectively compared with those of 63 patients treated with FCSEMSs between April 2018 and October 2024. The outcomes included clinical success, early complications, and recurrent biliary obstruction (RBO).
The baseline characteristics, including age (median 78 years), sex distribution (55.2% vs. 57.7% male), BMI (20.5 vs. 19.8), tumor size (27 mm vs. 30 mm), and stricture length (20 mm vs. 19.5 mm), were comparable between the groups. Procedural factors, including initial papillary cannulation (34.9% vs. 26.9%) and pancreatography (12.9% vs. 15.4%), were also similar in terms of incidence. Early complications were less common in the MHSEMS group (7.7% vs. 23.8%), with no cases of cholecystitis observed. Fewer early complications were observed with MHSEMS, suggesting potential clinical benefits. The RBO rates (7.7% vs. 15.9%, = 0.28) and median TRBO (151 vs. 141.5 days, = 0.87) were also comparable.
Although the differences in outcomes were not statistically significant, the incidence of early complications was lower, especially for cholecystitis, with the MHSEMS in the management of DMBO. Larger prospective studies are needed to confirm these preliminary findings.
覆膜自膨式金属支架（SEMS）是治疗不可切除的远端恶性胆管梗阻（DMBO）的标准方法，因为它们可延长复发性胆管梗阻（TRBO）的时间。然而，全覆膜SEMS（FCSEMS）会增加胆囊炎和胰腺炎的风险。本探索性研究评估了一种旨在降低这些风险的新型多孔部分覆膜SEMS（MHSEMS）。
回顾性比较了2018年4月至2024年10月期间26例接受MHSEMS治疗的DMBO患者与63例接受FCSEMS治疗的患者的临床数据。结果包括临床成功率、早期并发症和复发性胆管梗阻（RBO）。
两组患者的基线特征具有可比性，包括年龄（中位数78岁）、性别分布（男性分别为55.2%和57.7%）、体重指数（分别为20.5和19.8）、肿瘤大小（分别为27mm和30mm）以及狭窄长度（分别为20mm和19.5mm）。在操作因素方面，包括初始乳头插管（分别为34.9%和26.9%）和胰管造影（分别为12.9%和15.4%），其发生率也相似。MHSEMS组早期并发症较少见（分别为7.7%和23.8%），未观察到胆囊炎病例。MHSEMS观察到的早期并发症较少，提示可能具有临床益处。RBO发生率（分别为7.7%和15.9%，P = 0.28）和TRBO中位数（分别为151天和141.5天，P = 0.87）也具有可比性。
尽管结果差异无统计学意义，但在DMBO的治疗中，MHSEMS早期并发症的发生率较低，尤其是胆囊炎。需要更大规模的前瞻性研究来证实这些初步发现。
