NCT05640115

Obstruction of Malignancy: Percutaneous Renal vs Endoscopic Stent

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

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cancer
• Urinary Obstruction
• Malignancy
• Urinary Dysfunction
• Ureter Obstruction
• Ureter Injury

Interventions

Type	Name	Description
DEVICE	Ureteral Stent	A ureteral stent is a soft, hollow tube that is placed temporarily into the ureter. The stent allows the urine to drain. The stent has a coil on each end that keeps it from moving. The top end coils in the kidney and the lower end coils inside the bladder.
DEVICE	Percutaneous Nephrostomy Tube Placement	A percutaneous nephrostomy is the placement of a small, flexible rubber tube (catheter) through your skin into your kidney to drain your urine. It is inserted through your back or flank.

Timeline

• Start date: 2023-09-22
• Primary completion: 2024-08-21
• Completion: 2024-08-21
• First posted: 2022-12-07
• Last updated: 2024-12-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study