Ureteral Stents for Bladder Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether ureteral stents (thin tubes placed in the ureters to aid urine flow) affect the risk of complications after bladder cancer surgery. Participants will join one of two groups: one receiving stents and the other not, both following standard post-surgery care. The trial aims to understand how stents might influence recovery and complication rates after surgery. It suits individuals diagnosed with bladder cancer or similar pelvic cancers who have opted for bladder removal surgery. As an unphased trial, it allows participants to contribute to important research that could enhance surgical outcomes for future patients.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that ureteral stents, such as the double-J stent, are generally safe but carry some risks. One study found a 13.8% chance of these stents not working as expected. Another study indicated that patients with these stents faced a higher risk of developing upper tract urothelial carcinoma. Despite these risks, ureteral stents are designed to remain in place and are often used in bladder cancer treatments. Overall, while some risks exist, most patients tolerate the stents well.12345
Why are researchers excited about this trial?
Researchers are excited about this trial because it explores the impact of using ureteral stents during surgery for muscle-invasive bladder cancer. While the standard of care typically involves radical cystectomy with urinary diversion, this trial investigates whether adding ureteral stents or skipping them can influence post-operative outcomes. Ureteral stents are commonly used to help urine flow after surgery, but their necessity is being re-evaluated. By comparing patients with and without stents, researchers aim to determine if stents reduce complications or if they might be safely omitted, potentially leading to less invasive treatment options in the future.
What evidence suggests that this trial's treatments could be effective for bladder cancer?
This trial will compare the use of ureteral stents with no stents in bladder cancer surgeries. Studies have shown mixed results for ureteral stents, such as the double-J type. Some research indicates that these stents may help maintain proper urine flow after surgery. However, they also carry a risk of complications, including a higher chance of developing other urinary tract cancers. Specifically, one study found that patients with these stents had a 3.5 times greater risk of developing another type of urinary cancer. On the positive side, some stents had a low failure rate, with only about 14% not functioning as intended over time. Overall, the effectiveness of ureteral stents varies, making it important to weigh the benefits against potential risks. Participants in this trial will be randomized to receive either a ureteral stent or no stent during their surgery, and the outcomes will be analyzed.14678
Who Is on the Research Team?
Mihir S Shah, MD
Principal Investigator
Thomas Jefferson University
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo radical cystectomy with ileal conduit urinary diversion (RCIC) with or without ureteral stent placement
Post-operative Follow-up
Participants are monitored for post-operative outcomes and complications, including urinary leaks and ureteral strictures
What Are the Treatments Tested in This Trial?
Interventions
- No Ureteral Stent
- Ureteral Stent
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Subjects randomized to the stent arm will receive ureteral stents (double J or single J ureteral catheter, per surgeon preference) during radical cystectomy with ileal conduit urinary diversion (RCIC). Intraoperative use of indocyanine green with fluorescence imaging with be noted. Ureteral stents will be placed intraoperatively and removed at follow up visit per surgeon discretion. Either approach would be considered standard of care for muscle invasive bladder cancer, for which radical cystectomy with urinary diversion is the gold standard of treatment. They will follow the standard of care and be enrolled in the study for 12 months post-op. Risk of post-op complications will be analyzed.
Subjects randomized to the no-stent arm will undergo radical cystectomy with ileal conduit urinary diversion (RCIC) without placement of ureteral stents. They will follow the standard of care and be enrolled in the study for 12 months post-op. Risk of post-op complications will be analyzed.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Thomas Jefferson University
Lead Sponsor
Citations
Double-J stenting during TURBT increases risk of ... - PMC - NIH
Patients who underwent DJ stenting during TURBT for BC exhibited an increased risk of developing metachronous UTUC, suggesting a potential association that ...
Does Ureteral Stenting Increase the Risk of Metachronous ...
Purpose: Ureteral stenting in patients with bladder cancer may become neces- sary in order to protect the ureteral orifice during transurethral resection of ...
Safety and Efficacy of Double-J Metallic Mesh Ureteral ...
This study found that the double-J metallic mesh ureteral stent demonstrated a favorable cumulative stent failure rate of 13.8% (95% CI = 5.3%- ...
Bladder Cancer A Systematic Review and Meta-analysis ...
The objective of this study was to perform a systematic review of perioperative stenting strategies and postoperative outcomes in patients undergoing RCUD for ...
Double-J stenting during TURBT increases risk of ...
Patients who underwent DJ stenting during TURBT for BC exhibited an increased risk of developing metachronous UTUC, suggesting a potential ...
Stents: Ureteral
A stent designed for migration resistance. With the firm Percuflex Ureteral Stent, you can be confident in your stent placement.
Impact of double J stenting or nephrostomy placement ...
This study evaluated the impact of DJ compared to nephrostomy placement during TURBT for bladder cancer (BCa) on the incidence of metachronous UUTUCs. Methods: ...
Does Ureteral Stenting Increase the Risk of Metachronous ...
Purpose:Ureteral stenting in patients with bladder cancer may become necessary in order to protect the ureteral orifice during transurethral ...
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