Gastroenterology and Endoscopy Unit, IsMeTT/UPMC, Palermo, Italy.
Endoscopy. 2012 Oct;44(10):923-7. doi: 10.1055/s-0032-1310011. Epub 2012 Aug 14.
Benign biliary diseases include benign biliary stricture (BBS), lithiasis, and leaks. BBSs are usually treated with plastic stent placement; use of uncovered or partially covered metallic stents has been associated with failure related to mucosal hyperplasia. Some recently published series suggest the efficacy of fully covered self-expandable metal stents (FCSEMSs) in BBS treatment. We aimed to assess the efficacy and safety of FCSEMS in a large series of patients with BBS and a long follow-up.
Prospective multicenter clinical study at three tertiary referral centers: ISMETT/UPMC Italy, Palermo, San Paolo Hospital, Milan, and the ARNAS Civico Hospital, Palermo, Italy. All consecutive patients with BBS were treated with placement of FCSEMS rather than plastic stents, as first approach (11 patients, 17.7 %), or as a second approach after failure of other treatments (51 patients, 82.2 %).
From January 2008 to March 2011, 62 patients (40 male) were included. Mean period of FCSEMS indwelling was 96.7 days (standard deviation [SD] 6.5 days). In 15 patients (24.2 %) the SEMS migrated. Resolution of BBS occurred in 56 patients (90.3 %), while in 6 (9.6 %) the treatment failed. Mean (SD) follow-up after SEMS removal was 15.9 (10) months. FCSEMS placement as first- or second-line approach showed no difference in failure. Recurrence was observed in 4 /56 patients (7.1 %); all were transplant recipients: P = 0.01; odds ratio (OR) 1.2, confidence interval (CI) 1.1 - 1.3.
Despite the noteworthy migration rate, FCSEMSs should be considered effective for refractory benign biliary strictures. Further studies are needed to assess their role as a first approach in the management of BBS.
良性胆道疾病包括良性胆道狭窄（BBS）、结石和漏液。BBS 通常采用塑料支架置入治疗；使用无覆盖或部分覆盖的金属支架与黏膜过度增生导致的支架失败有关。一些最近发表的系列研究表明，全覆膜自膨式金属支架（FCSEMS）在 BBS 治疗中的疗效。我们旨在评估 FCSEMS 在一大组 BBS 患者中的疗效和安全性，并进行了长期随访。
这是一项在意大利 ISMETT/UPMC、米兰圣保禄医院和巴勒莫 ARNAS 公民医院这三个三级转诊中心进行的前瞻性多中心临床研究。所有 BBS 连续患者均采用 FCSEMS 治疗，而不是塑料支架作为首选方法（11 例，17.7%），或作为其他治疗失败后的二线治疗（51 例，82.2%）。
从 2008 年 1 月至 2011 年 3 月，共纳入 62 例患者（40 例男性）。FCSEMS 留置时间平均为 96.7 天（标准差 6.5 天）。15 例（24.2%）患者支架迁移。56 例（90.3%）患者 BBS 缓解，6 例（9.6%）治疗失败。支架取出后平均（SD）随访时间为 15.9（10）个月。FCSEMS 作为一线或二线治疗方法的失败率没有差异。4/56 例（7.1%）患者出现复发；均为移植受者：P=0.01；优势比（OR）1.2，置信区间（CI）1.1-1.3。
尽管支架迁移率较高，但 FCSEMS 仍可被认为是治疗难治性良性胆道狭窄的有效方法。需要进一步研究来评估其作为 BBS 管理一线治疗方法的作用。
