Obstruction of Malignancy: Percutaneous Renal vs Endoscopic Stent

Trial Title: Obstruction of Malignancy: Percutaneous Renal vs Endoscopic Stent

NCT ID: NCT05640115

Condition: Cancer
Urinary Obstruction
Malignancy
Urinary Dysfunction
Ureter Obstruction
Ureter Injury

Conditions: Official terms:
Neoplasms
Ureteral Obstruction

Conditions: Keywords:
urinary issues
urinary obstruction
cancer

Study type: Interventional

Study phase: Early Phase 1

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Investigator)

Intervention:

Intervention type: Procedure
Intervention name: Ureteral Stent
Description: 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.
Arm group label: Group A (Ureteral Stenting)

Intervention type: Procedure
Intervention name: Percutaneous Nephrostomy Tube Placement
Description: 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.
Arm group label: Group B (Percutaneous Nephrostomy)

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria - Patients must have unilateral or bilateral hydronephrosis secondary to extrinsic compression by malignancy on cross sectional imaging. - Age ≥18 years. - Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria - Anticoagulation that cannot be safely reversed in the peri-procedural time period. - History of severe allergy to contrast media. - Prior stent or nephrostomy in previous 6 months. - Urethral or ureteric stricture disease. - Lower urinary tract structural abnormalities or urinary diversion precluding retrograde ureteral stent placement. - On blood pressure support or clinically unstable. - Pregnant women are excluded from this study because the radiation from either procedure is known to have the potential for teratogenic or abortifacient effects. - Previous renal transplant. - Dialysis

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: The University of Chicago

Address:
City: Chicago
Zip: 60637
Country: United States

Status: Recruiting

Contact:
Last name: Cancer Clinical Trials Office

Phone: 855-702-8222
Email: cancerclinicaltrials@bsd.uchicago.edu

Start date: September 22, 2023

Completion date: September 1, 2025

Lead sponsor:
Agency: University of Chicago
Agency class: Other

Source: University of Chicago

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05640115