Obstruction of Malignancy: Percutaneous Renal vs Endoscopic Stent

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Ureter Obstruction; Malignancy; Urinary Obstruction; Urinary Dysfunction; Ureter Injury
• Intervention / Treatment: Procedure: Ureteral Stent; Procedure: Percutaneous Nephrostomy Tube Placement

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Clinical Trials; Phone Number: 1-855-702-8222; Email: cancerclinicaltrials@bsd.uchicago.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • The University of Chicago
      • Contact: Cancer Clinical Trials Office; Phone Number: 855-702-8222; Email: cancerclinicaltrials@bsd.uchicago.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A (Ureteral Stenting); Group A: Participants in this group will receive a standard of care ureteral stenting performed by a urologist.	Procedure: Ureteral Stent; 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.
Experimental: Group B (Percutaneous Nephrostomy); Participants in this group will receive a standard of care percutaneous nephrostomy tube placement performed by an interventional radiologist.	Procedure: Percutaneous Nephrostomy Tube Placement; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trial Feasibility (as assessed by number of enrolled and recruited patients)	The feasibility of a definitive randomized trial, specifically to quantify patient willingness to be randomly assigned treatment with retrograde ureteral stent versus percutaneous nephrostomy tube placement for malignant ureteral obstruction. The number of patient eligible and subsequent recruitment rates. Feasibility will be defined as successfully enrolling 50 patients in the 12 month enrollment period.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Success for Participants Randomized to Percutaneous Nephrostomy vs. Ureteral Stent Placement	The rate of technical success when randomizing patients to percutaneous nephrostomy or ureteral stent placement for managing malignant ureteral obstruction. This rate of technical success will be assessed by: Decompression failure (defined as any of the following: technical failure of study procedure, stable or worsening hydronephrosis on imaging at 3 months follow up, urosepsis within 3 months of procedure, or need for additional decompression procedure (stent or nephrostomy placement) within 2 months after initial procedure; Adverse surgical events (defined as grade ≥3 Clavien-Dindo classification); Patient reported outcomes at baseline, 7-day, 30-day and 90-day post-procedure using the Brief Pain Inventory, PROMIS Adult Physical Function Short Form (v2.0), and American Urological Association Symptom Score; Compliance rate with questionnaires; Reasons for non-randomisation, percentage of non-consenting participants who choose nephrostomy vs. retrograde ureteral stenting	6 months

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Parth Modi, MD, University of Chicago Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: November 28, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: cancer; urinary obstruction; urinary issues
• Additional Relevant MeSH Terms: Urologic Diseases; Ureteral Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Neoplasms; Ureteral Obstruction
• Other Study ID Numbers: IRB22-0835

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No