Department of Gastroenterology, the First People's Hospital of Yuhang District, Hangzhou, Zhejiang Province, China.
Gastrointest Endosc. 2013 Aug;78(2):277-84. doi: 10.1016/j.gie.2013.02.007. Epub 2013 Mar 23.
The use of various kinds of metal stents has emerged as an effective palliative treatment for malignant gastric outlet obstruction (GOO). However, most of these metal stents were designed for use in the esophagus or intestine and have a high incidence of stent obstruction and stent migration when used elsewhere.
To evaluate the efficacy and safety of individualized stents (designed according to the shape and size of the GOO) in order to determine whether such stents could reduce the incidence of stent obstruction and migration.
Multicenter, prospective, clinical trial.
Two tertiary-care referral centers.
Thirty-seven patients who presented with symptomatic unresectable malignant GOO caused by distal gastric cancer between April 2005 and June 2009.
Placement of the individualized metal stents.
The primary endpoint was to optimize stent resolution of proximal obstruction as determined by a GOO scoring system. Secondary endpoints were success rates, survival rates, and adverse events.
Technical and clinical success was achieved in 97.3% and 94.4% of patients, respectively. The rate of resolution of proximal obstruction by a proximal stent was 97.3%. There were no procedure-related perforations or deaths. No stent migration or obstruction by tumor growth were found. The mean survival time was 232 days (range 28-387 days).
A single-arm study in tertiary-care centers.
Placement of individualized stents is a safe and effective modality for the palliation of malignant GOO caused by distal stomach cancer and can help reduce tumor ingrowth and stent migration.
各种金属支架的使用已成为治疗恶性胃出口梗阻（GOO）的有效姑息治疗方法。然而，这些金属支架大多数是为食管或肠道设计的，在其他部位使用时支架阻塞和支架迁移的发生率较高。
评估个体化支架（根据 GOO 的形状和大小设计）的疗效和安全性，以确定这种支架是否可以降低支架阻塞和迁移的发生率。
多中心、前瞻性临床试验。
两家三级转诊中心。
2005 年 4 月至 2009 年 6 月期间因远端胃癌引起有症状不可切除的恶性 GOO 的 37 例患者。
放置个体化金属支架。
主要终点是通过 GOO 评分系统优化支架对近端梗阻的缓解程度。次要终点是成功率、生存率和不良事件。
分别有 97.3%和 94.4%的患者达到了技术和临床成功。近端支架近端梗阻缓解率为 97.3%。无手术相关穿孔或死亡。未发现支架迁移或肿瘤生长引起的阻塞。平均生存时间为 232 天（范围 28-387 天）。
单臂研究在三级保健中心进行。
放置个体化支架是治疗远端胃癌引起的恶性 GOO 的一种安全有效的方法，可以减少肿瘤生长和支架迁移。
