PURPOSE To assess the efficacy and safety of a newly developed fully covered irradiation stent (FCIS) compared with a partially covered irradiation stent (PCIS) in patients with unresectable malignant dysphagia. MATERIALS AND METHODS Data of 195 patients [158 (81.0%) males, median age of 75 years (range 49-89 years)] who underwent FCIS or PCIS placement for unresectable malignant dysphagia from January 2012 to November 2017 were retrospectively analyzed. The median follow-up time was 181 days (range 4-547 days). Outcomes were measured in terms of recurrent dysphagia (primary), technical success, clinical success, overall survival, and adverse events. Recurrent dysphagia was analyzed by Fine-Gray regression model. RESULTS The technical success rate was 97.8% (87/89) in the FCIS group and 99.1% (105/106) in the PCIS group (P = 0.59). The clinical success rate was 100.0% in both groups. There was no statistically significant difference in the recurrent dysphagia rate between the FCIS and PCIS groups (21.8% vs. 28.6%; P = 0.12). Compared with PCISs, FCISs were associated with a decrease in tissue/tumor growth rate (11.5% vs. 21.9%; P = 0.01), while stent migration rates were statistically comparable (11.5% vs. 5.7%; P = 0.23). The median overall survivals were comparable between the FCIS and PCIS groups (164 days vs. 162 days; P = 0.70). A dysphagia score of 4 and metastasis were risk factors for survival. No significant differences were observed in the rates of adverse events, including chest pain, fistula formation, hemorrhage, and aspiration pneumonia (P > 0.05). CONCLUSION For patients with unresectable malignant dysphagia, this newly developed FCIS can provide efficacy and safety comparable to those of a PCIS. Compared with PCIS, this FCIS is more successful in preventing tissue/tumor growth, with a comparable stent migration rate.

中文翻译：

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对于无法切除的恶性吞咽困难，新的完全覆盖的放射支架与部分覆盖的放射支架：单中心体验。

目的评估新开发的全覆盖放射支架（FCIS）与部分覆盖放射支架（PCIS）在无法切除的恶性吞咽困难患者中的疗效和安全性。材料与方法回顾性分析了2012年1月至2017年11月因无法切除的恶性吞咽困难而接受FCIS或PCIS安置的195例患者（158例（81.0％）男性，中位年龄75岁（范围49-89岁））的数据。中位随访时间为181天（范围4-547天）。根据复发性吞咽困难（原发性），技术成功率，临床成功率，总体生存率和不良事件来衡量结果。通过Fine-Gray回归模型分析复发性吞咽困难。结果FCIS组的技术成功率为97.8％（87/89），PCIS组的技术成功率为99.1％（105/106）（P = 0.59）。两组的临床成功率均为100.0％。FCIS组和PCIS组之间的吞咽困难复发率差异无统计学意义（21.8％对28.6％； P = 0.12）。与PCIS相比，FCIS与组织/肿瘤生长率降低相关（11.5％对21.9％； P = 0.01），而支架迁移率具有统计学可比性（11.5％对5.7％； P = 0.23）。FCIS组和PCIS组的中位总生存期相当（164天vs. 162天； P = 0.70）。吞咽困难评分为4和转移是生存的危险因素。不良事件发生率没有显着差异，包括胸痛，瘘管形成，出血和吸入性肺炎（P> 0.05）。结论对于无法切除的恶性吞咽困难的患者，这种新开发的FCIS可以提供​​与PCIS相当的功效和安全性。与PCIS相比，该FCIS在预防组织/肿瘤生长方面更为成功，且支架的移动速度相当。