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用于治疗食管癌引发的吞咽困难的可生物降解的支架植入和单剂量短程治疗的联合疗法与高的令人无法接受的并发

发布日期:2014-1-29 12:40:47 文章来源:GIE 作者次数:1644
    用于治疗食管癌引发的吞咽困难的可生物降解的支架植入和单剂量短程治疗的联合疗法与高的令人无法接受的并发症发生率息息相关

    2011128收到,201246批准,2012614网上发布。

    背景

    食管支架植入可即时改善吞咽困难的缓和性疗法,然而短程治疗可使吞咽困难得到更好的长期缓解。

    目的

    评估并行短程治疗和可生物降解的支架植入术的安全性和有效性。

    设计

    前瞻性单组研究。

    环境

    2所三级转诊中心

    患者

    19例由无法切除的食管癌导致的显著吞咽困难的患者,他们的预期寿命多于3个月。

    干预

    第一天单剂量短程治疗(12Gy),第二天进行可生物降解的支架植入。

    主要测量指标

    干预相关的主要并发症(由专家小组确定)和吞咽困难。

    结果

    本研究共纳入19例患者,其中,13例男性,中位年龄为66[四分范围(IQR)为59-71]);同时7例患者(37%)接受了姑息性化疗。纳入19例患者后,因超出安全阈值,该研究提前结束。17例患者(89%)共出现28例主要并发症。对9例患者(47%)的主要并发症进行测定,例如:干预相关的并发症有严重胸骨后痛(包括同时出现呕吐或无呕吐现象的患者)6例,呕血1例,复发吞咽困难2例。1个月后吞咽困难得分显著下降,从中位数3IQR 3-4)下降至中位数1(IQR 0-3)(P < .001)。尽管17例患者(89%)管腔已基本通畅,但由于胸骨后痛和呕吐,7例患者仍不能正常饮食。

    局限性

    缺乏常规内镜检查或对比食管图像来评估后续期间的复发吞咽困难。

    结论

    尽管管腔已恢复通畅,但因为短程治疗和可生物降解的支架植入联合疗法会导致高的令人无法接受的干预相关的主要并发症发生率,故我们不推荐其用于姑息性食管癌治疗。

    缩写词:SEMS,自膨式金属支架;WHO,世界卫生组织。

     


    Combination of biodegradable stent placement and single-dose brachytherapy is associated with an unacceptably high complication rate in the treatment of dysphagia from esophageal cancer

    Received 8 December 2011; accepted 6 April 2012. published online 14 June 2012.

    Background

    For the palliative treatment of dysphagia, esophageal stent placement provides immediate improvement, whereas brachytherapy offers better long-term relief.

    Objective

    To evaluate safety and efficacy of concurrent brachytherapy and biodegradable stent placement.

    Design

    Prospective, single-arm study.

    Setting

    Two tertiary-care referral centers.

    Patients

    Nineteen consecutive patients with significant dysphagia resulting from unresectable esophageal cancer, with a life expectancy of more than 3 months.

    Intervention

    Single-dose brachytherapy (12 Gy) on day 1 followed by biodegradable stent placement on day 2.

    Main Outcome Measurements

    Intervention-related major complications (determined by an expert panel) and dysphagia.

    Results

    Nineteen patients (13 men, median age 66 years [interquartile range (IQR) 59-71] years) were included; 7 patients (37%) also received palliative chemotherapy. After inclusion of 19 patients, the study was ended prematurely because the safety threshold was exceeded. In total, 28 major complications occurred in 17 patients (89%). In 9 patients (47%), major complications were determined intervention-related (severe retrosternal pain with or without vomiting [n = 6], hematemesis [n = 1], recurrent dysphagia [n = 2]. Dysphagia scores decreased significantly from a median of 3 (IQR 3-4) to a median of 1 (IQR 0-3) after 1 month (P < .001). Despite adequate luminal patency in 17 patients (89%), normal diet could not be tolerated in 7 patients (37%) because of retrosternal pain and vomiting.

    Limitations

    Lack of routine endoscopy or contrast esophagram to evaluate recurrent dysphagia during follow-up.

    Conclusion

    Despite restoration of luminal patency, a combined treatment of brachytherapy and biodegradable stent placement cannot be recommended for the palliative treatment of esophageal cancer because of an unacceptably high intervention-related major complication rate.

    Abbreviations:  SEMS, self-expandable metal stent, WHO, World Health Organization

     

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