Department of Gastroenterology, IRCCS Istituto Clinico Humanitas, Milan, Italy.
Gastrointest Endosc. 2010 Nov;72(5):927-34. doi: 10.1016/j.gie.2010.07.031.
Benign esophageal strictures refractory to standard dilation therapy present a challenging problem. Temporary plastic and metal stents have been proposed with inconclusive results.
To evaluate the efficacy and safety of a new biodegradable stent for the treatment of refractory benign esophageal strictures (RBESs).
Prospective study from 2 European endoscopy centers.
Twenty-one patients (11 men/10 women, mean age 60.2 ± 17.6 years) with RBESs defined according to the Kochman criteria treated by placement of a biodegradable stent (Ella stent).
Clinical and endoscopic follow-up was scheduled at 1, 2, 3, and 6 months and later only in case of dysphagia recurrence. Pre- and poststenting dysphagia status was graded according to a 5-point scale. Minor and major complication rates were prospectively assessed.
Stent insertion was technically successful in all of the patients. At 4 and 7 weeks, stent migration occurred in 2 patients (9.5%). At 3-month endoscopy, the stent appeared to be almost completely fragmented in all remaining patients. The median pre- and poststenting dysphagia scores were 3 (range 3-4) and 1 (range 0-2), respectively (P < .01), with a median follow-up of 53 weeks (range 25-88 weeks). In detail, 9 of 20 patients (45%) were dysphagia free at the end of the follow-up. No major complications occurred. Severe poststenting pain requiring analgesics developed in 3 patients, and minor bleeding was observed in 1 patient.
Limited follow-up; nonrandomized study.
In this preliminary study, the biodegradable stent showed a favorable risk/benefit ratio, achieving complete relief of dysphagia in nearly 50% of RBES patients without the occurrence of major complications. The use of this stent may be a valuable alternative to repeat endoscopic dilation. Larger studies with longer follow-up are needed.
标准扩张治疗无法缓解的良性食管狭窄是一个具有挑战性的问题。暂时的塑料和金属支架的应用效果尚无定论。
评估一种新型可生物降解支架治疗难治性良性食管狭窄（RBES）的疗效和安全性。
来自 2 个欧洲内镜中心的前瞻性研究。
21 例（11 名男性/10 名女性，平均年龄 60.2 ± 17.6 岁）患者根据 Kochman 标准诊断为 RBES，采用可生物降解支架（Ella 支架）进行治疗。
临床和内镜随访分别安排在 1、2、3 和 6 个月，之后仅在出现吞咽困难复发时进行。支架置入前后的吞咽困难状态按 5 分制分级。前瞻性评估轻微和严重并发症的发生率。
所有患者均成功进行了支架置入。在 4 周和 7 周时，有 2 例患者（9.5%）出现支架移位。在 3 个月的内镜检查时，所有其余患者的支架几乎完全碎裂。支架置入前后的中位吞咽困难评分分别为 3 分（范围为 3-4 分）和 1 分（范围为 0-2 分）（P <.01），中位随访时间为 53 周（范围为 25-88 周）。具体而言，在随访结束时，20 例患者中有 9 例（45%）无吞咽困难。无严重并发症发生。3 例患者出现支架置入后严重疼痛需要止痛药，1 例患者出现轻微出血。
随访时间有限；非随机研究。
在这项初步研究中，可生物降解支架具有较好的风险/效益比，在近 50%的 RBES 患者中实现了吞咽困难的完全缓解，且无严重并发症发生。该支架的使用可能是重复内镜扩张的一种有价值的替代方法。需要更大规模、随访时间更长的研究。
