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临床试验/NCT05640115
NCT05640115撤回早期 1 期

DECOMPRESS (DECompressing Obstruction of Malignancy: Percutaneous Renal vs Endoscopic Stent)

University of Chicago2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2023年9月22日最近更新:
适应症

试验速览

阶段
早期 1 期
状态
撤回
入组人数
2
试验地点
2
主要终点
Trial Feasibility (as assessed by number of enrolled and recruited patients)

研究概览

简要总结

This research study will compare two procedures commonly used to treat urinary obstruction due to cancer. Sometimes cancer blocks one or both ureters (narrow tubes in the body that carry urine from the kidneys to the bladder). When these ureters become blocked, the body can no longer properly drain urine. This blocking of the ureters is called urinary obstruction, which can lead to kidney problems, infection, and pain. Treatment options for urinary obstruction include ureteral stent placement and percutaneous nephrostomy tube placement. Both treatment options require a doctor to place soft tubes (like a catheter) inside the body to help the ureters properly drain urine. These two treatment options have different success rates, risks, and effects on quality of life. By doing this study, researchers hope to learn which treatment option is best for individuals who develop urinary obstruction because of cancer. Participation in this research will last about 3 months.

详细描述

This research study will compare two procedures commonly used to treat urinary obstruction due to cancer. Sometimes cancer blocks one or both ureters (narrow tubes in the body that carry urine from the kidneys to the bladder). When these ureters become blocked, the body can no longer properly drain urine. This blocking of the ureters is called urinary obstruction, which can lead to kidney problems, infection, and pain.

Treatment options for urinary obstruction include ureteral stent placement and percutaneous nephrostomy tube placement. Both treatment options require a doctor to place soft tubes inside the body to help the ureters properly drain urine. A ureteral stent is an internal drainage tube allowing urine to drain from your kidney down to your bladder. The percutaneous nephrostomy tube is a tube that comes out your back that drains urine into a bag. These two treatment options have different success rates, risks, and effects on quality of life. By doing this study, researchers hope to learn which treatment option is best for individuals who develop urinary obstruction due to cancer. Participation in this research will last about 3 months.

If you agree to participate:

  • The study doctor will not pick which one of the two treatments described above you will receive. We will use a computer to place you in one of the two study groups. The group the computer picks is by chance, like a flip of a coin. This is also called "randomization." You will have an equal chance of being in either group.
  • You will receive either a retrograde ureteral stent or a percutaneous nephrostomy tube. A member of the research team will tell you which of the two treatments you will get, after the selection has been made.

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
Double (Participant, Investigator)

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Trial Feasibility (as assessed by number of enrolled and recruited patients)

时间窗: 3 months

The feasibility of a definitive randomized trial, specifically to quantify patient willingness to be randomly assigned treatment with retrograde ureteral stent versus percutaneous nephrostomy tube placement for malignant ureteral obstruction. The number of patient eligible and subsequent recruitment rates. Feasibility will be defined as successfully enrolling 50 patients in the 12 month enrollment period.

次要结局

  • Rate of Success for Participants Randomized to Percutaneous Nephrostomy vs. Ureteral Stent Placement(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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