Efficacy and safety of a novel multi-hole fully covered self-expandable metallic stent for malignant distal biliary obstruction: Multicenter retrospective study

IF 4.7 2区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Digestive Endoscopy Pub Date : 2025-03-14 DOI:10.1111/den.15006

Sho Takahashi, Tsuyoshi Takeda, Makoto Kobayashi, Kei Saito, Kentaro Suda, Natsuyo Yamamoto, Suguru Mizuno, Rintaro Fukuda, Hiroki Kato, Ko Tomishima, Shigeto Ishii, Toshio Fujisawa, Yuya Hisada, Naminatsu Takahara, Takashi Sasaki, Hirofumi Kogure, Saburo Matsubara, Naoki Sasahira, Yousuke Nakai, Satoshi Mochida, Hiroyuki Isayama

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引用次数: 0

Abstract

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.

查看原文本刊更多论文

一种新型多孔全覆盖自膨胀金属支架治疗恶性胆道远端梗阻的疗效和安全性：多中心回顾性研究。

目的：有盖自膨胀金属支架（cems）是治疗恶性胆道远端梗阻（MDBO）的有效方法。然而，移徙是一个重大问题，需要加以预防。新型的多孔全cems (msems)，在覆盖的膜上有多个小孔，有望防止迁移。本研究旨在评价MHSEMS治疗MDBO的疗效和安全性。方法：这项多中心回顾性队列研究纳入了111例MDBO患者，这些患者在2022年9月至2023年8月期间接受了MHSEMS安置。主要观察指标为复发性胆道梗阻（RBO）率。次要结果为不良事件发生率、可移植性、技术和临床成功率以及RBO时间。结果：技术成功率100%，临床成功率94.6%。不良事件发生率为34.2%，RBO发生率为21.0%，非RBO发生率为17.1%。RBO包括支架移位1.9%，支架闭塞11.7%（包括长入5.7%，胆道碎片2.9%，胆道淤血1.9%，食物嵌塞1.0%），非闭塞性胆管炎（需要胆道引流）5.7%。非rbo事件包括内镜后逆行胆管造影胰腺炎11.7%，胆囊炎2.7%，非闭塞性胆管炎2.7%。88.9%的尝试成功取出支架。到RBO的中位时间为446天。结论：MHSEMS植入MDBO是有效和可行的，具有低迁移率，可接受的ae和可移除性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Digestive Endoscopy 医学-外科

CiteScore

10.10

自引率

15.10%

发文量

291

审稿时长

6-12 weeks

期刊介绍： Digestive Endoscopy (DEN) is the official journal of the Japan Gastroenterological Endoscopy Society, the Asian Pacific Society for Digestive Endoscopy and the World Endoscopy Organization. Digestive Endoscopy serves as a medium for presenting original articles that offer significant contributions to knowledge in the broad field of endoscopy. The Journal also includes Reviews, Original Articles, How I Do It, Case Reports (only of exceptional interest and novelty are accepted), Letters, Techniques and Images, abstracts and news items that may be of interest to endoscopists.