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临床试验/NCT01646476
NCT01646476已完成3 期

Comparison of Efficacy of Covered Versus Uncovered Self-expandable Metallic Stents for Treatment of Malignant Gastric Outlet Obstruction: a Prospective, Randomized Study

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2012年7月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
102
试验地点
1
主要终点
Stent patency

研究概览

简要总结

Malignant gastric outlet obstruction can result from gastric adenocarcinoma, leading to intractable vomiting, nausea, and poor oral food intake. Although self-expandable metallic stent (SEMS) insertion has excellent technical and clinical success rates for relieving gastric outlet obstruction symptoms, the uncovered SEMS is susceptible to re-stenosis because of tumor ingrowth through openings between the stent wire filaments. Therefore, the most common reason for stent failure in uncovered stents is tumor ingrowth.

The covered SEMS has a membrane that prevents ingrowth through the mesh wall and consequently shows lower rate of re-stenosis than uncovered SEMS. However, covered SEMS has a higher risk of stent migration compared to uncovered SEMS. Recent prospective, randomized study showed that there was no significant difference between uncovered and covered SEMS in terms of stent patency rate as well as technical and clinical success rates.

Recently the investigators developed new covered SEMS for gastric outlet obstruction. This new covered SEMS has features that may contribute to reducing migration rate: 1) partially covered design; 2)less radial force in central portion of stent; 3) presence of lasso which enable position of stent to be adjusted after deployment; 4)presence of protrusion in both sides of stent. This prospective, randomized study aimed to compare the effectiveness and side effects of newly developed covered SEMS with those of uncovered SEMS in patients with malignant gastric outlet obstruction from gastric cancer.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age: 20-80
  • patients with gastric outlet obstruction due to gastric adenocarinoma
  • patients with inoperable gastric adenocarcinoma due to distant metastasis or severe comorbidity
  • Gastric outlet obstruction score: 0-2
  • Symptoms consistent with gastric outlet obstruction such as nausea or vomiting
  • Findings consistent with gastric outlet obstruction in upper endoscopy or abdominal computed tomography

排除标准

  • Previous history of stent insertion or endoscopic dilation for gastric outlet obstruction
  • previous history of bypass surgery for gastric outlet obstruction
  • Multiple level of bowel obstruction confirmed in radiographic studies such as small bowel series or abdominal computed tomography
  • Borrmann type IV advanced gastric cancer

结局指标

主要结局

Stent patency

时间窗: 8 weeks after stent insertion

次要结局

  • Stent patency(16 weeks after stent insertion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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