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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 years old or older.
Select...
My cancer is causing swelling in my kidneys due to blockage.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Trial Feasibility (as assessed by number of enrolled and recruited patients)
Secondary outcome measures
Rate of Success for Participants Randomized to Percutaneous Nephrostomy vs. Ureteral Stent Placement
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
1,004 Previous Clinical Trials
819,717 Total Patients Enrolled
Parth Modi, MDPrincipal InvestigatorUniversity of Chicago Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a stent or nephrostomy in the last 6 months.I am 18 years old or older.I am not pregnant, as the study involves radiation that could harm a fetus.I have had a kidney transplant.I am on dialysis.I am on medication to stabilize my blood pressure or my condition is unstable.My blood thinner medication cannot be safely stopped for a procedure.I have a narrowing in my urethra or ureter.I cannot have a stent placed in my ureter due to urinary tract issues.My cancer is causing swelling in my kidneys due to blockage.
Research Study Groups:
This trial has the following groups:- Group 1: Group A (Ureteral Stenting)
- Group 2: Group B (Percutaneous Nephrostomy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research project currently recruiting participants?
"Clinicaltrials.gov reveals that, since its initial posting on March 1st 2023 and last update on November 28th 2022, this study has concluded recruitment for patients. Nevertheless, there are still 2,829 other clinical trials actively enrolling participants at the present moment."
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