Gastrointestinal Endoscopy, Azienda Ospedaliera San Paolo, Universitary Hospital, University of Milan, Via A. di Rudinì no. 8, 20142, Milan, Italy,
Dig Dis Sci. 2014 Sep;59(9):2308-13. doi: 10.1007/s10620-014-3158-7. Epub 2014 Apr 20.
Many benign biliary diseases (BBD) can be treated with fully covered, self-expandable metal stents (FCSEMS) but stent migration occurs in up to 35.7 %. The aim of this study was to prospectively assess the rate of, safety and effectiveness and stent migration of a new biliary FCSEMS with an anti-migration flap (FCSEMS-AF) in patients with BBD.
This was a prospective study from four Italian referral endoscopy centers of 32 consecutive patients (10 females and 22 males; mean age: 60.1 ± 14.8 years; range: 32-84 years) with BBD who were offered endoscopic placement of a FCSEMS-AF as first-line therapy.
Were 24 strictures and 8 leaks. Stent placement was technically successful in 32/32 patients (100 %). Immediate clinical improvement was seen in all 32 patients (100 %). One late stent migration occurred (3.3 %). FCSEMS-AF were removed from 30 of the 32 patients (93.7 %) at a mean (± SD) of 124.4 ± 84.2 days (range: 10-386 days) after placement. All patients remained clinically and biochemically well at 1- and 3-month follow-up. One patient (3.3 %) with a post-laparoscopic cholecystectomy stricture developed distal stent migration at 125 days.
This new FCSEMS with anti-migration flap seems to be a safe and effective first-line treatment option for patients with BBD.
许多良性胆道疾病（BBD）可以通过全覆膜自膨式金属支架（FCSEMS）进行治疗，但支架迁移的发生率高达 35.7%。本研究旨在前瞻性评估一种新型胆道 FCSEMS （FCSEMS-AF）在 BBD 患者中的应用效果、安全性和支架迁移率，该支架带有防迁移瓣。
这是一项来自意大利 4 个转诊内镜中心的前瞻性研究，共纳入 32 例连续患者（10 例女性和 22 例男性；平均年龄 60.1±14.8 岁；范围 32-84 岁），这些患者患有 BBD，拟行内镜下放置 FCSEMS-AF 作为一线治疗。
24 例为狭窄，8 例为漏。32 例患者（100%）支架置入技术均成功。所有 32 例患者（100%）均立即出现临床改善。1 例（3.3%）患者发生迟发性支架迁移。32 例患者中有 30 例（93.7%）在放置后平均（±SD）124.4±84.2 天（范围 10-386 天）时取出 FCSEMS-AF。所有患者在 1 个月和 3 个月随访时均保持临床和生化良好。1 例（3.3%）胆囊切除术后腹腔镜下狭窄患者在 125 天时发生远端支架迁移。
这种新型带防迁移瓣的 FCSEMS 似乎是 BBD 患者的一种安全有效的一线治疗选择。
