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


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 (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.This research study wil

Trial Eligibility

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

Study Info

Organization

University of Chicago


Primary Outcome

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


Outcome Timeframe 3 months

NCTID NCT05640115

Phases EARLY_PHASE1

Primary Purpose TREATMENT

Start Date 2023-09-22

Completion Date 2025-06-01

Enrollment Target 60

Interventions

PROCEDURE Ureteral Stent

PROCEDURE Percutaneous Nephrostomy Tube Placement

Locations Recruiting

The University of Chicago

United States, Illinois, Chicago


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