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ナカイ ヨウスケ
NAKAI Yousuke
中井 陽介 所属 医学部 医学科（東京女子医科大学病院） 職種 教授・基幹分野長 |
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| 論文種別 | 原著 |
| 言語種別 | 英語 |
| 査読の有無 | 査読あり |
| 表題 | Efficacy and safety of a novel multi-hole fully covered self-expandable metallic stent for malignant distal biliary obstruction: Multicenter retrospective study. |
| 掲載誌名 | 正式名：Digestive endoscopy 略 称：Dig Endosc ISSNコード：14431661/09155635 |
| 掲載区分 | 国内 |
| 巻・号・頁 | 37(7),pp.766-774 |
| 著者・共著者 | TAKAHASHI Sho,TAKEDA Tsuyoshi,KOBAYASAHI Makoto,SAITO Kei,SUDA Kentaro,YAMAMOTO Natsuyo,MISUNO Suguru,FUKUDA Rintaro,KATO Hiroki,TOMISHIMA Ko,ISHII Shigeto,FUJISAWA Toshio,HISADA Yuya,TAKEHARA Naminatsu,SASAKI Takashi,KOGURE Hirofumi,MATSUBARA Saburo,SASAHIRA Naoki,NAKAI Yosuke,MOCHIDA Satoshi,ISAYAMA Hiroyuki |
| 発行年月 | 2025/07 |
| 概要 | OBJECTIVES: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.METHODS: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.RESULTS: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.CONCLUSION:The placement of MHSEMS for MDBO was effective and feasible, demonstrating low migration rates, acceptable AEs, and removability. |
| DOI | 10.1111/den.15006 |
| PMID | 40084472 |