Interventional Radiology Research Group (GITMI), University of Zaragoza, Zaragoza, Spain.
Interventional Radiology Unit, UDIAT-Centre Diagnòstic, Hospital Universitario Parc Tauli Sabadell, Medicine Department Universidad Autónoma de Barcelona, Barcelona, Spain.
Eur Radiol. 2020 Aug;30(8):4486-4495. doi: 10.1007/s00330-020-06797-7. Epub 2020 Mar 27.
Benign strictures of the bile duct may be difficult to treat endoscopically due to altered bowel anatomy. Furthermore, recurrence of stenosis and symptoms remains high. The aim of the Spanish Prospective Registry BiELLA study was to investigate the safety and efficacy of absorbable stents in the treatment of benign biliary strictures and their outcomes on the medium and long-term follow-up.
A prospective, multicenter, observational, non-randomized study (the BiELLA study) was conducted from January 2014 to September 2018. One hundred fifty-nine patients with benign biliary strictures, mostly postsurgical, were enrolled for implantation of absorbable biliary stents in the 11 participating Spanish tertiary hospitals. The average patient follow-up was 45.4 ± 15.9 months (range, 12-60 months). The follow-up data included symptoms, biochemical parameters, and ultrasound images at 1, 6, and 12 months and then yearly for up to 60 months.
The immediate technical and clinical success rates were 100%. In all patients, stent placement resulted in improvement of clinical symptoms and biochemical parameters. The primary mean patency for stent was 86.7, 79.6, and 78.9% at 12, 36, and 60 months, respectively (95% CI). Biliary restenosis and occlusion occurred in 40 (26.6%) patients. Of the 40 patients, 18 (12%) patients were treated with a second stent and 22 (14.6%) patients had operative repair of the recurrent strictures. There were no major complications associated with stent implantation.
Implantation of an absorbable polydioxanone biliary stent is safe and effective for treatment of benign biliary strictures refractory to balloon dilatation or other biliary intervention.
• Percutaneous implantation of biodegradable prostheses for the treatment of benign postsurgical biliary strictures is a safe and effective procedure. • More than 75% of the patients presented patency of the stented biliary tree at 5 years follow-up. • Absorbable stents improved clinical symptoms and signs (jaundice, itching, fever), and laboratory parameters in a few days after stent placement.
由于肠道解剖结构的改变，良性胆管狭窄可能难以通过内镜进行治疗。此外，狭窄和症状的复发率仍然很高。西班牙前瞻性注册研究 BiELLA 的目的是研究可吸收支架治疗良性胆管狭窄的安全性和有效性，以及它们在中、长期随访中的结果。
这是一项从 2014 年 1 月到 2018 年 9 月进行的前瞻性、多中心、观察性、非随机研究（BiELLA 研究）。159 例良性胆管狭窄患者（主要为术后），在 11 家参与的西班牙三级医院接受可吸收胆管支架植入术。平均患者随访时间为 45.4±15.9 个月（范围，12-60 个月）。随访数据包括 1、6 和 12 个月以及随后每年的症状、生化参数和超声图像，最长随访时间为 60 个月。
即刻技术和临床成功率均为 100%。在所有患者中，支架置入均改善了临床症状和生化参数。支架的主要通畅率分别为 12、36 和 60 个月时的 86.7%、79.6%和 78.9%（95%CI）。40 例（26.6%）患者出现胆道再狭窄和闭塞。40 例患者中，18 例（12%）患者接受了第二次支架治疗，22 例（14.6%）患者接受了复发性狭窄的手术修复。支架植入无重大并发症。
植入可吸收聚二氧杂环己酮胆管支架治疗对球囊扩张或其他胆道介入治疗无效的良性胆管狭窄是安全有效的。
• 经皮植入生物可降解假体治疗良性术后胆道狭窄是一种安全有效的方法。• 5 年随访时，超过 75%的患者胆道支架通畅。• 可吸收支架可在支架置入后几天内改善临床症状和体征（黄疸、瘙痒、发热）以及实验室参数。
