Clinical trial NCT05640115: Obstruction of Malignancy: Percutaneous Renal vs Endoscopic Stent
Official title: DECOMPRESS (DECompressing Obstruction of Malignancy: Percutaneous Renal vs Endoscopic Stent)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Cancer
Urinary Obstruction
Malignancy
Urinary Dysfunction
Ureter Obstruction
Ureter Injury
Keywords: urinary issues
urinary obstruction
cancer
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Trial Feasibility (as assessed by number of enrolled and recruited patients)
timeFrame: 3 months
Secondary outcomes:
measure: Rate of Success for Participants Randomized to Percutaneous Nephrostomy vs. Ureteral Stent Placement
timeFrame: 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago Comprehensive Cancer Center
name: Parth Modi, MD
role: PRINCIPAL_INVESTIGATOR
References: