Obstruction of Malignancy: Percutaneous Renal vs Endoscopic Stent

NCT05640115 | Withdrawn Early Phase 1 DMC FDA Device

• 1 other identifier: IRB22-0835
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Urinary Obstruction; Malignancy; Urinary Dysfunction; Ureter Obstruction; Ureter Injury

Keywords

urinary issues; urinary obstruction; cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rate of Success for Participants Randomized to Percutaneous Nephrostomy vs. Ureteral Stent Placement

  6 months

Study Arms (2)

Group A (Ureteral Stenting)

EXPERIMENTAL

Group A: Participants in this group will receive a standard of care ureteral stenting performed by a urologist.

Device: Ureteral Stent

Group B (Percutaneous Nephrostomy)

EXPERIMENTAL

Participants in this group will receive a standard of care percutaneous nephrostomy tube placement performed by an interventional radiologist.

Device: Percutaneous Nephrostomy Tube Placement

Interventions

Ureteral Stent DEVICE

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.

Group A (Ureteral Stenting)

Percutaneous Nephrostomy Tube Placement DEVICE

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.

Group B (Percutaneous Nephrostomy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Neoplasms; Ureteral Obstruction

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Parth Modi, MD

  University of Chicago Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 7, 2022
• Study Start: September 22, 2023
• Primary Completion: August 21, 2024
• Study Completion: August 21, 2024
• Last Updated: December 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (1)