Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands.
Department of Gastroenterology and Hepatology, Amsterdam Medical Center, Amsterdam, The Netherlands.
Endoscopy. 2018 Dec;50(12):1146-1155. doi: 10.1055/a-0602-4169. Epub 2018 Jun 8.
Dilation is the standard of care for recurrent benign esophageal strictures (BES). Biodegradable stents may prolong the effect of dilation and reduce recurrences. Efficacy and safety of dilation and biodegradable stent placement early in the treatment algorithm of recurrent BES were compared.
This multicenter, randomized study enrolled patients with BES treated with previous dilations to ≥ 16 mm. The primary end point was number of repeat endoscopic dilations for recurrent stricture within 3 and 6 months. Secondary outcomes through 12 months included safety, time to first dilation for recurrent stricture, dysphagia, and level of activity.
At 3 months, the biodegradable stent group (n = 32) underwent significantly fewer endoscopic dilations for recurrent stricture compared with the dilation group (n = 34; < 0.001). By 6 months, the groups were similar. The number of patients experiencing adverse events was similar between the groups. Two patients in the biodegradable stent group died after developing tracheoesophageal fistulas at 95 and 96 days post-placement; no deaths were attributed to the stent. Median time to first dilation of recurrent stricture for the biodegradable stent group was significantly longer (106 vs. 41.5 days; = 0.003). Dysphagia scores improved for both groups. Patients in the biodegradable stent group had a significantly higher level of activity through 12 months ( < 0.001).
Biodegradable stent placement is associated with temporary reduction in number of repeat dilations and prolonged time to recurrent dysphagia compared with dilation. Additional studies are needed to better define the exact role of biodegradable stent placement to treat recurrent BES.
扩张术是复发性良性食管狭窄（BES）的标准治疗方法。可生物降解支架可能会延长扩张的效果并减少复发。本研究比较了在复发性 BES 治疗算法中早期使用扩张术和可生物降解支架置入术的疗效和安全性。
这是一项多中心、随机研究，纳入了先前接受过扩张术治疗至≥16mm 的 BES 患者。主要终点是 3 个月和 6 个月内复发性狭窄再次内镜扩张的次数。次要终点包括安全性、首次复发性狭窄扩张的时间、吞咽困难和活动水平，随访时间为 12 个月。
在 3 个月时，与扩张组（n=34）相比，可生物降解支架组（n=32）接受复发性狭窄内镜扩张的次数明显减少（<0.001）。到 6 个月时，两组之间相似。两组患者不良事件的发生次数相似。两名患者在放置后 95 天和 96 天分别发生气管食管瘘，随后死亡，但这与支架无关。可生物降解支架组首次复发性狭窄扩张的中位时间明显更长（106 vs. 41.5 天；=0.003）。两组的吞咽困难评分均有所改善。在 12 个月时，可生物降解支架组患者的活动水平显著更高（<0.001）。
与扩张术相比，可生物降解支架置入术可暂时减少重复扩张的次数，并延长复发性吞咽困难的时间。需要进一步的研究来更好地确定可生物降解支架置入术治疗复发性 BES 的确切作用。
