BACKGROUND Endoscopic treatment of post-cholecystectomy biliary strictures (PCBS) with multiple plastic biliary stents placed sequentially is a minimally invasive alternative to surgery but requires multiple interventions. Temporary placement of a single fully-covered self-expanding metal stent (FCSEMS) may offer safe and effective treatment with fewer re-interventions. Long-term effectiveness of treatment with FCSEMS to obtain PCBS resolution has not yet been studied. METHODS In this prospective multi-national study in patients with symptomatic benign biliary strictures (N = 187) due to various etiologies received a FCSEMS with scheduled removal at 6-12 months and were followed for 5 years. We report here long-term outcomes of the subgroup of patients with PCBS (N = 18). Kaplan Meier analyses assessed long-term freedom from re-stenting. Adverse events were documented. RESULTS Endoscopic removal of the FCSEMS was achieved in 83.3% (15/18) of patients after median indwell of 10.9 (range 0.9-13.8) months. In the remaining 3 patients (16.7%), the FCSEMS spontaneously migrated and passed without complications. At the end of FCSEMS indwell, 72% (13/18) of patients had stricture resolution. At 5 years after FCSEMS removal, 84.6% (95% CI 65.0-100.0%) of patients who had stricture resolution at FCSEMS removal remained stent-free. In addition, at 75 months after FCSEMS placement, the probability of remaining stent-free was 61.1% (95% CI 38.6-83.6%) for all patients. Stent or removal related serious adverse events occurred in 38.9% (7/18) all resolved without sequalae. CONCLUSIONS In patients with symptomatic PCBS, temporary placement of a single FCSEMS intended for 10-12 months indwell is associated with long-term stricture resolution up to 5 years. Temporary placement of a single FCSEMS may be considered for patients with PCBS not involving the main hepatic confluence. TRIAL REGISTRATION NUMBERS NCT01014390; CTRI/2012/12/003166; Registered 17 November 2009.

中文翻译：

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用完全覆盖的自膨胀金属支架治疗胆囊切除术后胆道狭窄 - 5 年随访后的结果。

背景技术用依次放置的多个塑料胆管支架对胆囊切除术后胆道狭窄（PCBS）进行内窥镜治疗是手术的微创替代方案，但需要多次干预。临时放置一个完全覆盖的自膨式金属支架 (FCSEMS) 可以提供安全有效的治疗，减少再干预。尚未研究使用 FSEMS 治疗以获得 PCBS 分辨率的长期有效性。方法 在这项前瞻性的多国研究中，由于各种病因导致有症状的良性胆道狭窄（N = 187）患者接受了 FSEMS，计划在 6-12 个月内取出，并随访 5 年。我们在此报告 PCBS 患者亚组（N = 18）的长期结果。Kaplan Meier 分析评估了重新支架的长期自由度。记录了不良事件。结果 83.3% (15/18) 的患者在中位留置 10.9 个月（范围 0.9-13.8）个月后实现了内镜下切除 FSEMS。在其余 3 名患者 (16.7%) 中，FCSEMS 自发迁移并通过，没有并发症。在 FSEMS 留置结束时，72% (13/18) 的患者出现狭窄消退。在 FSEMS 移除后 5 年，84.6% (95% CI 65.0-100.0%) 在 FSEMS 移除时出现狭窄消退的患者仍然没有支架。此外，在 FSEMS 放置后 75 个月，所有患者保持无支架的概率为 61.1% (95% CI 38.6-83.6%)。38.9% (7/18) 发生支架或移除相关的严重不良事件，全部解决且无后遗症。结论 在有症状的 PCBS 患者中，打算留置 10-12 个月的单个 FSEMS 的临时放置与长达 5 年的长期狭窄解决有关。对于不累及主要肝汇合处的 PCBS 患者，可考虑临时放置单个 FCSEMS。试用注册号 NCT01014390；CTRI/2012/12/003166；2009 年 11 月 17 日注册。