Background and Aims

In recent years, the feasibility and safety of endoscopic placement of different biodegradable biliary stents have been investigated. New, helicoidally shaped, biliary and pancreatic biodegradable stents have been developed for endoscopic use. Stents are provided in different sizes and with 3 expected speeds of degradation: slow (11 weeks), medium (20 days), and fast (12 days). The aim of this study was to evaluate degradation time, technical outcomes, and safety of these stents.

Methods

This was a single-center, prospective, pilot study (August 2018 to January 2019) of consecutive patients with indication for biliary or pancreatic plastic stent positioning during ERCP. The primary outcome was the evaluation of degradation time of the stents, which was controlled by abdominal radiograph. Secondary outcomes were the evaluation of specific stent-related technical features (loadability, pushability, and fluoroscopic visibility) as compared with commonly used plastic stents and adverse events (AEs).

Results

Thirty-eight patients (11 women [28.9%]; median age, 68.05 ± 10.74 years) who received 53 biodegradable stents (34 [64.2%] biliary and 19 [35.8%] pancreatic stents) were enrolled in the study. Thirty-five (66%) slow-degrading stents, 6 (11.3%) medium-degrading stents, and 12 (22.6%) fast-degrading stents were used. At time 1, partial degradation of the stents was present in 48 cases (90.6%). Five stents (9.4%) prematurely migrated. At the subsequent time 2 evaluation, complete degradation occurred in 100% of cases. Stent loadability was defined as excellent in all cases. Pushability of the stent was scored as excellent in 48 cases (90.5%), good in 4 cases (7.5%), and fair in 1 case (1.9%). Fluoroscopic visualization was excellent in 11 cases (20.8%), good in 39 cases (73.6%), and fair in 3 (5.6%). Only 1 AE of mild post-ERCP pancreatitis occurred.

Conclusions

The results of our study suggest that the biodegradation of the new biliary and pancreatic stents is reliable and in line with expected times and technically successful in a variety of indications. Further randomized multicenter studies are required to validate our preliminary findings. (Clinical trial registration number: NCT03767166.)

中文翻译：

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新型胆道和胰腺可生物降解支架置入：单中心、前瞻性、试点研究（带视频）。

 背景和目标

近年来，人们对内镜下放置不同生物可降解胆道支架的可行性和安全性进行了研究。新型螺旋形胆道和胰腺可生物降解支架已开发用于内窥镜用途。支架有不同尺寸和 3 种预期降解速度：慢速（11 周）、中速（20 天）和快速（12 天）。本研究的目的是评估这些支架的降解时间、技术成果和安全性。

 方法

这是一项单中心、前瞻性、试点研究（2018 年 8 月至 2019 年 1 月），研究对象为在 ERCP 期间有胆管或胰腺塑料支架定位指征的连续患者。主要结果是评估支架的降解时间，该时间由腹部X光检查控制。次要结果是与常用塑料支架相比，对特定支架相关技术特征（负载性、推动性和荧光可见度）的评估和不良事件 (AE)。

 结果

接受 53 个生物可降解支架（34 个 [64.2%] 胆管支架和 19 个 [35.8%] 胰腺支架）的 38 名患者（11 名女性 [28.9%]；中位年龄，68.05 ± 10.74 岁）参与了这项研究。使用了 35 个（66%）慢降解支架、6 个（11.3%）中度降解支架和 12 个（22.6%）快速降解支架。在时间 1 时，48 例 (90.6%) 出现支架部分降解。五个支架 (9.4%) 过早移位。在随后的时间 2 评估中，100% 的情况发生完全降解。在所有情况下支架负载能力均被定义为优异。支架推送性评价为优48例（90.5%）、良4例（7.5%）、可1例（1.9%）。透视视野优11例（20.8%），良39例（73.6%），一般3例（5.6%）。仅发生 1 例轻度 ERCP 术后胰腺炎 AE。

 结论

我们的研究结果表明，新型胆道和胰腺支架的生物降解是可靠的，符合预期时间，并且在多种适应症中技术上取得了成功。需要进一步的随机多中心研究来验证我们的初步研究结果。 （临床试验注册号：NCT03767166。）