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
试验速览
- 阶段
- 2 期
- 入组人数
- 78
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
Silicone-covered metallic ureteral stent
Deployment of a silicone-covered metallic ureteral stent for malignant ureteral obstruction and compare the results with placement of a double-J stent in terms of primary patency rate at 3 month follow-up (primary end point)
干预措施: Silicone-covered metallic stent (Device)
Double-J stent
Placement of a double-J stent for malignant ureteral obstruction and compare these results to deployment of a silicone-covered metallic stent in terms of primary patency rate at 3 month follow-up.
干预措施: Double-J stent (Device)
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
Ji Hoon Shin
Associate professor
Asan Medical Center