Clinical trial · Interventional
STENT X: a Randomized Trial to Assess Stent-free Radical Cystectomy
STENT X Non-stent Genito-urinary Tract Reconstruction After Radical Cystectomy for Bladder Cancer - a Prospective, Randomized, Controlled and Multi Institutional Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study withdrawn prior to enrollment. Principle Investigator changed institutions prior to obtaining IRB approval.
Summary
Brief summary (as posted)
Radical Cystectomy (RC) remains the gold standard for localized muscle-invasive bladder cancer (MIBC); however, use of ureteral stents at time of surgery remains controversial without level 1 evidence to comment on risks or benefits of their use. RC complications commonly include urinary tract infections (UTIs), pyelonephritis, ureteroileal leakage and stenosis, and can occur with either ileal conduit or orthotopic neobladder diversions. Traditionally, ureteral stents are thought to support anastomotic healing and reduce the risk of anastomotic leakage and strictures; however, emerging evidence from retrospective studies suggests that stent use may paradoxically increase rates of postoperative morbidity. This randomized, multicenter and prospective study aims to compare 30-day postoperative complication rates between stented and non-stented urinary diversions in patients undergoing RC for MIBC, in both ileal conduit or neobladder with either robotic or open approaches.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer Requiring Cystectomy | Bladder Neoplasm | PROBABILISTIC | 0.70 |
| Ureteral Stents | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| no ureteral stent | Device | — | UNRESOLVED |
| ureteral stents | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- ureteral stents placed at time of cystectomy
- description
- standard of care ureteral stent placement at time of radical cystectomy (control arm)
- interventionNames
- Device: ureteral stents
- type
- EXPERIMENTAL
- label
- stent-free, no stent placement at time of cystectomy
- description
- forgo ureteral stent placement at time of radical cystectomy (intervention arm)
- interventionNames
- Device: no ureteral stent
Primary outcomes (1)
- measure
- Post-operative readmission rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults (\> 18 years old) * Muscle invasive bladder cancer or non-muscle invasive bladder cancer with indication of Radical Cystectomy * No concomitant surgeries like nephrectomies, colectomies or removal of other organs affected by the tumor (Except standard lymph node dissections as well as in men the prostate and seminal vesicles and in women the uterus, fallopian tubes, ovaries and vagina, that are considered part of the oncological radical cystectomy.) * Patients who have the capacity to understand the study procedures and provide written informed consent Exclusion Criteria: * Simultaneous surgical procedures (except those specified in the inclusion criteria that are considered part of a routine radical cystectomy) * History of prior urinary diversion * Patients who decline to participate, lack understanding of the study's purpose, or are unable to provide informed consent * Cystectomy for other reasons than Bladder cancer * Previous radiation therapy in the pelvis for any reason * Extremely debilitated patients, malnourished individuals, or those undergoing palliative or hygienic cystectomy
References
Publications (0)
Data not yet available