A fully covered self-expandable metal stent with antimigration features for benign biliary strictures: a prospective, multicenter cohort study
A fully covered self-expandable metal stent with antimigration features for benign biliary strictures: a prospective, multicenter cohort study
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DOI：
10.1016/j.gie.2014.10.026
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发表时间：
2015-05-01
影响因子：
7.7
通讯作者：
Siersema, Peter D.
中科院分区：
文献类型：
--
作者：
Walter, Daisy;Laleman, Wim;Siersema, Peter D.
背景：自膨胀金属支架（SEMSs）越来越多地用于治疗良性胆道狭窄（bbs）。设计了一种新型的全覆盖SEMS (fcems)，其末端呈发散状，具有高一致性，以防止支架的迁移。目的：评价一种具有抗迁移功能的新型FCSEMS的疗效。设计：前瞻性队列研究。环境：荷兰和比利时的五家医院。患者：连续的BBS患者。干预：FCSEMS安置3个月。主要结果测量：初步和长期临床成功，支架迁移率和安全性。结果：纳入38例患者（男性24例，平均年龄53±16岁）。37例（97%）患者支架置入术成功。2例患者在支架移除前死于不相关的原因，没有关于这些患者狭窄解决的数据。35例患者中有28例（80%）取得了初步临床成功。在支架移除后的随访中，28例患者中有6例（21%）出现症状性复发狭窄。总体而言，长期临床成功率为63%（35例患者中有22例）。35例患者中有11例（31%）发生支架迁移，其中5例有症状（14%），6例无症状（17%）。10例（29%）患者共发生11例严重不良事件，其中以胆管炎（n = 5）最为常见。局限性：非随机研究设计。结论：该新型FCSEMS放置后取得了良好的初步临床成功，但与其他FCSEMS相比，狭窄复发处于较高范围。抗迁移设计不能阻止迁移的患者持续存在的结构显著数量。
Background: Self-expandable metal stents (SEMSs) are increasingly used for the treatment of benign biliarystrictures (BBSs). A new fully covered SEMS (FCSEMS) with flared ends and high conformability was designed to prevent migration of the stent.Objective: To evaluate the efficacy of a novel FCSEMS with antimigration features.Design: Prospective cohort study.Setting: Five hospitals in the Netherlands and Belgium.Patients: Consecutive patients with BBS.Intervention: FCSEMS placement for 3 months.Main Outcome Measurements: Initial and long term clinical success, stent migration rate and safety.Results: Thirty-eight patients (24 men; mean age, 53 +/- 16 years) were included. Stent placement was technically successful in 37 patients (97%). Two patients died of an unrelated cause before stent removal, and no data on these patients were available on stricture resolution. Initial clinical success was achieved in 28 of 35 patients (80%). During follow-up after stent removal, a symptomatic recurrent stricture developed in 6 of 28 patients (21%). Overall, the long-term clinical success rate was 63% (22 of 35 patients). Stent migration occurred in 11 of 35 patients (31%), including 5 symptomatic (14%) and 6 asymptomatic (17%) migrations. In total, 11 serious adverse events occurred in 10 patients (29%), with cholangitis (n = 5) being most common.Limitations: Nonrandomized study design.Conclusions: Good initial clinical success was achieved after placement of this novel FCSEMS, but stricture recurrence was in the upper range compared with other FCSEMSs. The antimigration design could not prevent migration in a significant number of patients with a persisting stricture.