BACKGROUND AND AIMS Self-expanding metal stents (SEMSs) when deployed across the gastroesophageal junction (GEJ) can lead to reflux with risks of aspiration. A SEMS with a tricuspid antireflux valve (SEMS-V) was designed to address this issue. The aim of this study was to evaluate the efficacy and safety of this stent. METHODS A phase III, multicenter, prospective, noninferiority, randomized controlled trial was conducted on patients with malignant dysphagia requiring SEMSs to be placed across the GEJ. Patients were randomized to receive SEMSs with no valve (SEMS-NV) or SEMS-V. Postdeployment dysphagia score at 2 weeks and Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) questionnaire score at 4 weeks were measured. Patients were followed for 24 weeks. RESULTS Sixty patients were randomized (SEMS-NV: 30 patients, mean age 67 ± 13 years; SEMS-V: 30 patients, mean age 65 ± 12 years). Baseline dysphagia scores (SEMS-NV, 2.5 ± .8; SEMS-V, 2.5 ± .8) and GERD-HRQL scores (SEMS-NV, 11.1 ± 8.2; SEMS-V, 12.8 ± 8.3) were similar. All SEMSs were successfully deployed. A similar proportion of patients in both arms improved from advanced dysphagia to moderate to no dysphagia (SEMS-NV, 71%; SEMS-V, 74%; 95% confidence interval, 1.93 [-17.8 to 21.7]). The dysphagia scores were also similar across all follow-up time points. Mean GERD-HRQL scores improved by 7.4 ± 10.2 points in the SEMS-V arm and by 5.2 ± 8.3 in the SEMS-NV group (P = .96). The GERD-HRQL scores were similar across all follow-up time points. Aspiration pneumonia occurred in 3.3% in the SEMS-NV arm and 6.9% in the SEMS-V arm (P = .61). Migration rates were similar (SEMS-NV, 33%; SEMS-V, 48%; P = .29). Two SEMS-V spontaneously fractured. There was no perforation, food impaction, or stent-related death in either group. CONCLUSIONS The SEMS-V was equally effective in relieving dysphagia as compared with the SEMS-NV. Presence of the valve did not increase the risks of adverse events. GERD symptom scores were similar between the 2 stents, implying either that the valve was not effective or that all patients on proton pump inhibitors could have masked the symptoms of GERD. Studies with objective evaluations such as fluoroscopy and/or pH/impedance are recommended. (Clinical trial registration number: NCT02159898.).

中文翻译：

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第三阶段，多中心，前瞻性，单盲，非劣效，随机对照试验，该试验采用新型带抗反流阀的食管支架（带视频）。

背景和目的自膨胀金属支架（SEMS）跨胃食管连接点（GEJ）部署时，可能导致反流，有吸入危险。具有三尖瓣防回流阀（SEMS-V）的SEMS旨在解决此问题。这项研究的目的是评估这种支架的功效和安全性。方法对恶性吞咽困难，需要在GEJ上放置SEMS的恶性吞咽困难的患者进行了一项III期，多中心，前瞻性，非劣效，随机对照试验。患者随机接受无瓣膜的SEMS（SEMS-NV）或SEMS-V。测量了第2周的部署后吞咽困难评分和第4周的胃食管反流疾病-健康相关生活质量（GERD-HRQL）问卷评分。随访患者24周。结果60例患者被随机分组​​（SEMS-NV：30例，平均年龄67±13岁；SEMS-V：30名患者，平均年龄65±12岁）。基线吞咽困难评分（SEMS-NV，2.5±.8; SEMS-V，2.5±.8）和GERD-HRQL评分（SEMS-NV，11.1±8.2; SEMS-V，12.8±8.3）相似。所有SEMS已成功部署。两组患者中有相似比例的患者从晚期吞咽困难改善为中度吞咽困难至无吞咽困难（SEMS-NV，71％； SEMS-V，74％； 95％置信区间，1.93 [-17.8至21.7]）。在所有随访时间点的吞咽困难评分也相似。在SEMS-V组中，平均GERD-HRQL得分提高7.4±10.2分，在SEMS-NV组中，提高5.2±8.3（P = 0.96）。在所有随访时间点上，GERD-HRQL评分均相似。在SEMS-NV组中发生吸入性肺炎的发生率为3.3％，在SEMS-V组中发生发生率为6.9％（P = 0.61）。迁移率相似（SEMS-NV，33％； SEMS-V，48％； P = 0.29）。两个SEMS-V自发断裂。两组均无穿孔，食物撞击或支架相关的死亡。结论与SEMS-NV相比，SEMS-V在缓解吞咽困难方面同样有效。瓣膜的存在不会增加不良事件的风险。两个支架之间的GERD症状评分相似，这表明瓣膜无效或所有使用质子泵抑制剂的患者都可能掩盖了GERD症状。建议进行客观评估的研究，例如荧光检查和/或pH /阻抗。（临床试验注册号：NCT02159898。）。瓣膜的存在不会增加不良事件的风险。两个支架之间的GERD症状评分相似，这表明瓣膜无效或所有使用质子泵抑制剂的患者都可能掩盖了GERD症状。建议进行客观评估的研究，例如荧光检查和/或pH /阻抗。（临床试验注册号：NCT02159898。）。瓣膜的存在不会增加不良事件的风险。两个支架之间的GERD症状评分相似，这表明瓣膜无效或所有使用质子泵抑制剂的患者都可能掩盖了GERD症状。建议进行客观评估的研究，例如荧光检查和/或pH /阻抗。（临床试验注册号：NCT02159898。）。