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Obstruction of Malignancy: Percutaneous Renal vs Endoscopic Stent

Primary Purpose

Cancer, Urinary Obstruction, Malignancy

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ureteral Stent
Percutaneous Nephrostomy Tube Placement
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring urinary issues, urinary obstruction, cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of ChicagoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A (Ureteral Stenting)

Group B (Percutaneous Nephrostomy)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
November 28, 2022
Last Updated
October 5, 2023
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT05640115
Brief Title
Obstruction of Malignancy: Percutaneous Renal vs Endoscopic Stent
Official Title
DECOMPRESS (DECompressing Obstruction of Malignancy: Percutaneous Renal vs Endoscopic Stent)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2023 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Urinary Obstruction, Malignancy, Urinary Dysfunction, Ureter Obstruction, Ureter Injury
Keywords
urinary issues, urinary obstruction, cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A (Ureteral Stenting)
Arm Type
Experimental
Arm Description
Group A: Participants in this group will receive a standard of care ureteral stenting performed by a urologist.
Arm Title
Group B (Percutaneous Nephrostomy)
Arm Type
Experimental
Arm Description
Participants in this group will receive a standard of care percutaneous nephrostomy tube placement performed by an interventional radiologist.
Intervention Type
Procedure
Intervention Name(s)
Ureteral Stent
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Nephrostomy Tube Placement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Trial Feasibility (as assessed by number of enrolled and recruited patients)
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Rate of Success for Participants Randomized to Percutaneous Nephrostomy vs. Ureteral Stent Placement
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trials
Phone
1-855-702-8222
Email
cancerclinicaltrials@bsd.uchicago.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parth Modi, MD
Organizational Affiliation
University of Chicago Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cancer Clinical Trials Office
Phone
855-702-8222
Email
cancerclinicaltrials@bsd.uchicago.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Obstruction of Malignancy: Percutaneous Renal vs Endoscopic Stent

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