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Stent vs Tube for Urinary Obstruction Due to Cancer

Phase < 1
Recruiting
Led By Parth Modi, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years.
Patients must have unilateral or bilateral hydronephrosis secondary to extrinsic compression by malignancy on cross sectional imaging.
Must not have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare 2 treatments for bladder obstruction caused by cancer. Stents & tubes placed in body help ureters drain urine. Researchers hope to learn which option is best for individuals with urinary obstruction.

Who is the study for?
This trial is for adults over 18 with urinary obstruction from cancer, causing kidney swelling. They must understand and sign consent. Excluded are those on certain blood thinners, with ureteric strictures or severe contrast allergies, unstable blood pressure, pregnant women (due to radiation risks), previous kidney transplant recipients, dialysis patients, or those who've had similar treatments in the last 6 months.
What is being tested?
The study compares two procedures to treat urinary blockage due to cancer: placing a ureteral stent versus percutaneous nephrostomy tube placement. Both involve inserting tubes to help drain urine properly. The goal is to determine which method offers better outcomes and quality of life over a three-month period.
What are the potential side effects?
Potential side effects include discomfort at the tube insertion site, infection risk around the area where the catheter enters the body, possible damage during insertion leading to bleeding or injury, and allergic reactions if contrast media is used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My cancer is causing swelling in my kidneys due to blockage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant, as the study involves radiation that could harm a fetus.
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I have had a kidney transplant.
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I am on dialysis.
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I am on medication to stabilize my blood pressure or my condition is unstable.
Select...
My blood thinner medication cannot be safely stopped for a procedure.
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I have a narrowing in my urethra or ureter.
Select...
I cannot have a stent placed in my ureter due to urinary tract issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Trial Feasibility (as assessed by number of enrolled and recruited patients)
Secondary study objectives
Rate of Success for Participants Randomized to Percutaneous Nephrostomy vs. Ureteral Stent Placement

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group B (Percutaneous Nephrostomy)Experimental Treatment1 Intervention
Participants in this group will receive a standard of care percutaneous nephrostomy tube placement performed by an interventional radiologist.
Group II: Group A (Ureteral Stenting)Experimental Treatment1 Intervention
Group A: Participants in this group will receive a standard of care ureteral stenting performed by a urologist.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ureteral Stent
2005
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,056 Previous Clinical Trials
760,849 Total Patients Enrolled
Parth Modi, MDPrincipal InvestigatorUniversity of Chicago Comprehensive Cancer Center

Media Library

Percutaneous Nephrostomy Tube Placement Clinical Trial Eligibility Overview. Trial Name: NCT05640115 — Phase < 1
Urinary Obstruction Research Study Groups: Group A (Ureteral Stenting), Group B (Percutaneous Nephrostomy)
Urinary Obstruction Clinical Trial 2023: Percutaneous Nephrostomy Tube Placement Highlights & Side Effects. Trial Name: NCT05640115 — Phase < 1
Percutaneous Nephrostomy Tube Placement 2023 Treatment Timeline for Medical Study. Trial Name: NCT05640115 — Phase < 1
~18 spots leftby Jun 2025
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