STENT X: a Randomized Trial to Assess Stent-free Radical Cystectomy
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- ureteral stents
- no ureteral stent
Treatment groups
190 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov