应用可移除的全覆膜自膨式金属支架有效治疗胆管良性狭窄：一项欧洲的前瞻性多中心研究

Effective treatment of benign biliary strictures with a removable, fully covered, self-expandable metal stent: A prospective, multicenter European study
应用可移除的全覆膜自膨式金属支架有效治疗胆管良性狭窄：一项欧洲的前瞻性多中心研究
 
Abstract （摘要）
Background: Temporary placement of removable, fully covered, self-expandable metal stents (fcSEMS) for treatment of benign biliary strictures (BBS) has been reported to be effective. However, the optimal extraction time point remains unclear and stent migration has been a major concern.
背景：有关报道称，临时放置可移除的全覆膜自膨式金属支架（fcSEMS）治疗良性胆道狭窄（BBS）是有效的。然而，最佳的移除时间仍不清楚，并且支架的移位一直是所面临的重要问题。
 
Objective: The objective of this study was to evaluate the efficacy and safety of this treatment modality using an fcSEMS with a special antimigration design and prolonged stent indwell time.
目的：本研究的目的是使用具有特殊防迁移设计和留置时间延长的fcSEMS来评估该治疗方式的有效性和安全性。
 
Methods: We performed a prospective, single-arm study at six tertiary care centers in Europe. Patients with BBS underwent endoscopic or percutaneous implantation of an fcSEMS (GOREVIABIL Biliary Endoprosthesis, W.L. Gore & Associates, Flagstaff, AZ, USA). The devices were scheduled to be removed nine months later, and patients were to return for follow-up for an additional 15 1months.
方法：我们在欧洲的六个三级医疗中心进行了一项前瞻性单臂研究。对BBS患者实施了经内镜或经皮fcSEMS植入术（(GOREVIABIL Biliary Endoprosthesis, W.L. Gore & Associates, Flagstaff, AZ, USA）。该支架计划在9个月后移除，对患者将进行15个月的随访。
 
Results: Forty-three patients were enrolled in the study. Stricture etiology was chronic pancreatitis in the majority of patients (57.5%). All fcSEMS were placed successfully, either endoscopically (76.7%) or percutaneously (23.3%). Stent migration was observed in two patients (5.2%). Primary patency of the SEMS prior to removal was 73.0%. All attempted stent removals were successful. At removal, stricture was resolved or significantly improved without need for further therapy in 78.9% of patients. Stricture recurrence during a follow-up of two years post-implant was observed in two patients.
结果：共43例患者被纳入研究。大多数胆管狭窄患者（57.5％）的病因是慢性胰腺炎。所有fcSEMS均通过内镜（76.7％）或经皮（23.3％）成功放置。两名患者（5.2％）出现支架移位。自膨式金属支架移除前的通畅率为73.0％。所有支架的均移除成功。支架取出后，78.9％的患者无需进一步治疗即可解除狭窄或狭窄明显改善。两名患者在植入后两年的随访中出现狭窄复发。
 
Conclusions: Temporary placement of the fcSEMS is a feasible, safe and effective treatment for BBS. The design of the device used in this study accounts for very low migration rates and facilitates easy stent retrieval, even after it has been in place for up to 11 months.
结论：临时放置fcSEMS治疗BBS是可行，安全，有效的。本研究中的支架设计具有极低的移位率，即使在放置11个月后支架仍易于取出。

翻译：于廷廷 审校：张立超 侯森林