Not yet recruiting NCT07655284

STENT X: a Randomized Trial to Assess Stent-free Radical Cystectomy

Phase III Interventional Bladder Cancer Requiring Cystectomy Ureteral Stents

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: ureteral stents, no ureteral stent.
Who it may be relevant to: Registry conditions: Bladder Cancer Requiring Cystectomy, Ureteral Stents. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Brazil
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

STENT X Non-stent Genito-urinary Tract Reconstruction After Radical Cystectomy for Bladder Cancer - a Prospective, Randomized, Controlled and Multi Institutional Trial

Overview

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.

Interventions

Device ureteral stents
standard of care single-J externalized ureteral stents to be placed at time of radical cystectomy
Device no ureteral stent
no ureteral stents used at time of radical cystectomy

Primary outcome measures

Post-operative readmission rate [Time frame: 30-days after surgery]

Secondary outcome measures (8)

length of stay [Time frame: 30 days]
procedure duration [Time frame: 30 days]
blood transfusion rate [Time frame: 30 days]
Emergency room visits [Time frame: 30 days]
patient reported pain on analog scale [Time frame: 30 days]
ureteral stricture rate [Time frame: 30 days]
urine leak rate [Time frame: 30 days]
pyelonephritis rate [Time frame: 30 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment

Study locations

United States · 1 center

Brigham and Women's Hospital — Boston

Brazil · 1 center

Instituto do Câncer do Estado de São Paulo (ICESP) — São Paulo

Identifiers

NCT: NCT07655284 · 2025P002187

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗