跳至主要内容
临床试验/NCT01823575
NCT01823575Unknown2 期

Comparison of the Efficacy of Silicone-covered Metallic Ureteral Stent and Double-J Stent for Malignant Ureteral Obstruction: A Prospective Randomized Controlled Trial Based on Exploratory Research

Asan Medical Center2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
2 期
入组人数
78
试验地点
2
主要终点
primary patency rate at 3-month F.U.

研究概览

简要总结

Malignant ureteral obstruction often necessitates chronic urinary diversion and is associated with high rates of failure with traditional double-J ureteral stents. To overcome drawbacks of the double-J stent, recently, metallic stents have been used to manage for palliative treatment in patients with ureteral obstruction associated with end stage malignant disease. The success rates of metallic stents have been reported to be high and the method proved to be useful in patients with malignant ureteral obstruction. In addition, covered metallic stents have many advantages compared with bare metallic stents, such as lower rate of tissue invasion and higher patency rate. However, there is little investigation about comparison of clinical efficacy between covered-metallic stents and double-J stents in malignant ureteral obstruction.

Therefore, investigators plan to perform a prospective randomized study to compare clinical efficacy of silicone-covered metallic ureteral stent and double-J ureteral stent in patients with malignant ureteral obstruction.

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
None

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 years
  • Malignant mid- to distal ureteral obstruction by abdominal or pelvic malignancy with overt hydronephrosis documented on CT scans
  • Expected life expectancy more than three months

排除标准

  • History of unilateral nephrectomy or bladder reconstruction
  • History of kidney transplantation
  • History of severe allergy to contrast media
  • State of dialysis
  • Performance status - 3 or 4 on ECOG scale

结局指标

主要结局

primary patency rate at 3-month F.U.

时间窗: 3 month after stent deployment

Confirmation of patency of the stents with USG and renal biochemistry, without additional intervention.

次要结局

  • Primary patency rate at 6- and 12-month F.U.(at 6 and 12 months after stent deployment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ji Hoon Shin

Associate professor

Asan Medical Center

研究点 (2)

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