STENT X Non-stent Genito-urinary Tract Reconstruction After Radical Cystectomy for Bladder Cancer - a Prospective, Randomized, Controlled and Multi Institutional Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Withdrawn
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 190
- Locations
- 2
- Primary Endpoint
- Post-operative readmission rate
Study Overview
Brief Summary
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.
Detailed Description
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. Randomization between ureteroenteric anastomosis with or without ureteral stent placement will occur at time of surgery; the surgeon will know this information at time of surgery and the patient will be aware of the placement of stents following surgery as these are externalized and visible. The primary outcome will be complication rate in 30 days after the surgery. Secondary outcomes of this trial will include: length of stay, procedure duration, emergency room visits, patient reported pain, anastomotic leakage rate, ureteral stricture rate, post-operative nephrostomy tube placement, differences in complication rates between interrupted and running suture technique. The study will be conducted across three academic institutions: Brigham and Women's Hospital (BWH), Massachusetts General Hospital (MGH) and Instituto do Câncer do Estado de São Paulo (ICESP), Brazil.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
ureteral stents placed at time of cystectomy
standard of care ureteral stent placement at time of radical cystectomy (control arm)
Intervention: ureteral stents (Device)
stent-free, no stent placement at time of cystectomy
forgo ureteral stent placement at time of radical cystectomy (intervention arm)
Intervention: no ureteral stent (Device)
Outcomes
Primary Outcomes
Post-operative readmission rate
Time Frame: 30-days after surgery
percent of patients re-admitted
Secondary Outcomes
- patient reported pain on analog scale(30 days)
- length of stay(30 days)
- procedure duration(30 days)
- blood transfusion rate(30 days)
- Emergency room visits(30 days)
- ureteral stricture rate(30 days)
- urine leak rate(30 days)
- pyelonephritis rate(30 days)
Investigators
Timothy Clinton
Associate Surgeon
Brigham and Women's Hospital