Department of Gastroenterology and Endoscopy, National Cancer Center Hospital East, Chiba, Japan.
Office of Clinical Research Support, National Cancer Center Hospital East, Chiba, Japan.
Gastrointest Endosc. 2017 Sep;86(3):492-499. doi: 10.1016/j.gie.2017.01.011. Epub 2017 Jan 27.
Biodegradable stents are reportedly effective for refractory benign esophageal strictures; however, little is known about their use in patients with refractory stricture after endoscopic submucosal dissection (ESD) or chemoradiotherapy (CRT) for esophageal cancer. This study aimed to evaluate the effectiveness of biodegradable stents for these patients.
Patients with refractory benign esophageal stricture with a dysphagia score (DS) of 2 or worse and for whom the passage of a standard size endoscope was not possible were eligible. The primary endpoint was the proportion of those who improved their DSs (% DS improved) at 12 weeks after stent placement, and the secondary endpoints were the proportion of those who improved their DSs at 24 weeks, dysphagia-free survival (DFS), and adverse events.
Eighteen patients (men:women, 15:3; median age, 72 years; range, 53-80) were enrolled. Twelve patients improved their DS at 12 weeks (% DS improved, 66.7%; 90% CI, 44.6%-84.4%). Also, 8 of 11 patients (72.7%) after esophagectomy, 4 of 6 patients (66.7%) after ESD, and 3 of 4 patients (75%) after CRT improved at 12 weeks. Three patients who were treated with esophagectomy maintained their DS improvement at 24 weeks (% DS improved, 16.7%; 95% CI, 3.6%-41.4%). The median DFS was 14.1 weeks (95% CI, 13.0-19.0). One patient who had ESD and CRT developed an esophagobronchial fistula 3 months after stent placement.
Biodegradable stents are effective and tolerable for refractory benign esophageal strictures after treatment for esophageal cancer; however, long-term efficacy was limited, especially after ESD or CRT. (Clinical trial registration number: UMIN000008054.).
据报道，可生物降解支架对于难治性良性食管狭窄是有效的；然而，对于内镜黏膜下剥离术（ESD）或放化疗（CRT）治疗食管癌后发生难治性狭窄的患者，其使用情况知之甚少。本研究旨在评估可生物降解支架对此类患者的疗效。
纳入吞咽困难评分（DS）为 2 或更差且无法通过标准尺寸内镜的难治性良性食管狭窄患者。主要终点为支架置入后 12 周时 DS 改善的患者比例（% DS 改善），次要终点为 24 周时 DS 改善、无吞咽困难生存（DFS）和不良事件的患者比例。
共纳入 18 例患者（男：女，15：3；中位年龄为 72 岁；范围，53-80 岁）。12 例患者在 12 周时 DS 改善（% DS 改善，66.7%；90%CI，44.6%-84.4%）。此外，11 例接受食管切除术、6 例接受 ESD 和 4 例接受 CRT 的患者中，分别有 8 例（72.7%）、4 例（66.7%）和 3 例（75%）在 12 周时改善。3 例接受食管切除术的患者在 24 周时维持 DS 改善（% DS 改善，16.7%；95%CI，3.6%-41.4%）。中位 DFS 为 14.1 周（95%CI，13.0-19.0）。1 例接受 ESD 和 CRT 的患者在支架置入后 3 个月发生食管支气管瘘。
可生物降解支架对于食管癌治疗后难治性良性食管狭窄是有效且耐受良好的；然而，长期疗效有限，尤其是在 ESD 或 CRT 后。（临床试验注册号：UMIN000008054。）
