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| ID | Type | Description | Link |
|---|---|---|---|
| JT 45452 | Other Identifier | JeffTrial Number | |
| 2025-117 | Other Identifier | PRMC Number |
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Subjects will be randomized into 2 groups (stent or no stent) prior to radical cystectomy with ileal conduit urinary diversion (RCIC). 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.
Patients who are indicated for RCIC will be recruited for this prospective RCT. 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.
Patients will be randomized 1:1 to receive stent or no stent during RCIC (Stent: N=35, No Stent: N=35). Randomization will be stratified by surgical approach (open vs. robotic vs. hybrid). The randomization schedule will be created by the study statistician using the method of random permuted blocks.
Stent placement, if applicable, will be a one-time occurrence inserted during RCIC, and be removed typically between 7-21 days post-op at the discretion of the surgeon. For this study, subjects will continue to be followed for up to 1-year post-op. Subjects will be enrolled in this study for 12 months.
Post treatment, the patient will have a follow-up visit within 30 days post-operatively, 3 months follow-up visit (+/- 1 week), 6 months follow-up visit (+/- 21 days), and 12 months follow-up visit (+/- 21 days). Patient will be followed for 12 months post treatment or until their death. Additional visits or follow-ups may be indicated for instances of the need for replacement of ureteral stents and catheters or percutaneous nephrostomies. The need for surgical repair for a ureteral leak or stricture may also occur.
The Principal Investigator hypothesizes that patients with no ureteral stent placement during RCIC will not be associated with a higher risk of post-op complications compared to those with a ureteral stent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Ureteral Stent | Experimental | 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. |
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| Arm 2: No Ureteral Stent | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ureteral Stent Placement | Procedure | Placement of ureteral stents (double J or single J) intraoperatively during radical cystectomy with ileal conduit urinary diversion (RCIC). Stent placement will be a one-time occurrence inserted during RCIC, and be removed typically between 7-21 days post-op at the discretion of the surgeon. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of urinary tract infection (UTI) | UTI is defined as clinical symptoms consistent with UTI as well as a positive urine culture showing ≥ 10⁵ CFU/mL of a uropathogen. Subjects who do not complete the 90-day follow-up period but had no evidence of infection at last follow-up will be excluded from the analysis. the Mantel-Haenszel stratified-adjusted estimate of the risk difference for incidence of urinary tract infection (risk in no stent arm - risk in stent arm) will be estimated along with one-sided (upper bound) 80% confidence interval. | 90 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of urinary leak | Measurement will be the presence or absence of a urinary leak. Urinary leak will be identified through clinical symptoms, laboratory abnormalities, or imaging findings. Relevant assessments include vitals, laboratory testing (CBC and BMP/CMP), urinalysis, and imaging reports. Data will be aggregated as the number and percentage of participants with a urinary leak within the time frame. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of readmission | Measurement will be the presence or absence of hospital readmission. Readmission is defined as any unplanned hospital admission during follow-up. Assessments include vitals, adverse event review, labs, urinalysis, and imaging performed at the scheduled post-operative visits. Data will be aggregated as the number and percentage of participants with ureteral stricture within the time frame. |
Inclusion Criteria:
Individuals must meet all the following inclusion criteria to be eligible to participate in the study:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mihir S Shah, MD | Contact | 215-955-6961 | Mihir.Shah@jefferson.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mihir S Shah, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospital | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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Patients will be randomized 1:1 to receive stent or no stent during RCIC. Randomization will be stratified by surgical approach (open vs. robotic vs. hybrid). The randomization schedule will be created by the study statistician using the method of random permuted blocks.
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| No Ureteral Stent | Procedure | Radical cystectomy with ileal conduit urinary diversion (RCIC) performed without ureteral stent placement. |
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| Indocyanine Green with Fluorescence Imaging | Diagnostic Test | Indocyanine green (ICG) with fluorescence imaging is an advanced technique used to enhance the visualization of the ureters during complex pelvic surgeries, such as those for bladder cancer. The technology helps surgeons identify the ureters, which are the tubes connecting the kidneys to the bladder, and distinguish them from surrounding tissues. |
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| 90 days after surgery |
| Incidence of ureteral stricture | Measurement will be the presence or absence of ureteral stricture. Ureteral stricture will be identified through clinical symptoms, laboratory abnormalities, or imaging findings. Relevant assessments include vitals, laboratory testing (CBC and BMP/CMP), urinalysis, and imaging reports. Data will be aggregated as the number and percentage of participants with ureteral stricture within the time frame. | 12 months after surgery |
| within 90 days |
| Incidence of secondary intervention or procedure related to UTI or Urine Leak or Ureteral Stricture | Measurement will be the presence or absence of secondary intervention or procedure related to UTI or Urine Leak or Ureteral Stricture. These will be identified through hospital readmissions. Readmission is defined as any unplanned hospital admission during follow-up. Assessments include vitals, adverse event review, labs, urinalysis, and imaging performed at the scheduled post-operative visits. Data will be aggregated as the number and percentage of participants with ureteral stricture within the time frame. | within 12 months after surgery |
| Jefferson Einstein Philadelphia Hospital | Not yet recruiting | Philadelphia | Pennsylvania | 19141 | United States |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D002295 | Carcinoma, Transitional Cell |
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D061848 | Optical Imaging |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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