Takahashi Sho, Takeda Tsuyoshi, Kobayashi Makoto, Saito Kei, Suda Kentaro, Yamamoto Natsuyo, Mizuno Suguru, Fukuda Rintaro, Kato Hiroki, Tomishima Ko, Ishii Shigeto, Fujisawa Toshio, Hisada Yuya, Takahara Naminatsu, Sasaki Takashi, Kogure Hirofumi, Matsubara Saburo, Sasahira Naoki, Nakai Yousuke, Mochida Satoshi, Isayama Hiroyuki
Department of Gastroenterology, Graduate School of Medicine, Juntendo University, Tokyo, Japan.
Department of Hepato-Biliary-Pancreatic Medicine, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Dig Endosc. 2025 Jul;37(7):766-774. doi: 10.1111/den.15006. Epub 2025 Mar 14.
Covered self-expandable metallic stents (CSEMS) are effective for managing malignant distal biliary obstruction (MDBO). However, migration is a significant problem, which requires prevention. The novel multi-hole fully CSEMS (MHSEMS), which features multiple small holes on the covered membrane, is expected to prevent migration. This study aimed to evaluate the efficacy and safety of MHSEMS for MDBO.
This multicenter retrospective cohort study included 111 patients with MDBO who underwent MHSEMS placement between September 2022 and August 2023. The primary outcome was the recurrent biliary obstruction (RBO) rate. The secondary outcomes were adverse event (AE) rates, removability, technical and clinical success rates, and time to RBO.
The technical success rate was 100%, and the clinical success rate was 94.6%. AEs occurred in 34.2% of patients, with RBO in 21.0% and non-RBO AEs in 17.1%. RBO included stent migration in 1.9%, stent occlusion in 11.7% (including ingrowth in 5.7%, biliary debris in 2.9%, hemobilia in 1.9%, and food impaction in 1.0%), and nonocclusion cholangitis (requiring biliary drainage) in 5.7%. Non-RBO AEs included post-endoscopic retrograde cholangiopancreatography pancreatitis in 11.7%, cholecystitis in 2.7%, and nonocclusion cholangitis in 2.7%. Stent removal was successful in 88.9% of attempts. The median time to RBO was 446 days.
The placement of MHSEMS for MDBO was effective and feasible, demonstrating low migration rates, acceptable AEs, and removability.
覆膜自膨式金属支架（CSEMS）在治疗恶性远端胆管梗阻（MDBO）方面有效。然而，支架移位是一个重大问题，需要加以预防。新型多孔全覆膜自膨式金属支架（MHSEMS）在覆膜上有多个小孔，有望预防支架移位。本研究旨在评估MHSEMS治疗MDBO的有效性和安全性。
这项多中心回顾性队列研究纳入了2022年9月至2023年8月期间接受MHSEMS置入术的111例MDBO患者。主要结局是复发性胆管梗阻（RBO）率。次要结局包括不良事件（AE）发生率、可取出性、技术成功率和临床成功率以及发生RBO的时间。
技术成功率为100%，临床成功率为94.6%。34.2%的患者发生了AE，其中RBO发生率为21.0%，非RBO AE发生率为17.1%。RBO包括支架移位1.9%、支架堵塞11.7%（包括向内生长5.7%、胆泥2.9%、胆道出血1.9%和食物嵌塞1.0%）以及非阻塞性胆管炎（需要胆管引流）5.7%。非RBO AE包括内镜逆行胰胆管造影术后胰腺炎11.7%、胆囊炎2.7%和非阻塞性胆管炎2.7%。88.9%的尝试成功取出支架。发生RBO的中位时间为446天。
MHSEMS置入治疗MDBO有效且可行，移位率低，AE可接受，且具有可取出性。
