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A New Fully Covered Irradiation Stent Versus a Partially Covered Irradiation Stent for Unresectable Malignant Dysphagia: A Single-Center Experience.
CardioVascular and Interventional Radiology ( IF 2.8 ) Pub Date : 2019-05-31 , DOI: 10.1007/s00270-019-02252-3
Chao Wang 1 , Jian Lu 1 , Yong Wang 1 , Guang-Yu Zhu 1 , Li Chen 1 , Jun-Chao Li 1 , Tian-Kuan Li 1 , Lei Chen 2 , Jin-He Guo 1
Affiliation  

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:

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。
更新日期:2019-05-29
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