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

ConditionsBladder Cancer Requiring CystectomyUreteral Stents
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • ureteral stents

    Device

    standard of care single-J externalized ureteral stents to be placed at time of radical cystectomy

  • no ureteral stent

    Device

    no ureteral stents used at time of radical cystectomy

Treatment groups

190 Participants
are divided into 2 treatment groups
Group A: ureteral stents placed at time of cystectomyActive comparator 1 intervention
Group B: stent-free, no stent placement at time of cystectomyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Post-operative readmission rate

percent of patients re-admitted

Time frame
30-days after surgery

Secondary outcomes

1

length of stay

index hospitalization (days after surgery until discharge, excluding pre-admission if applicable)

Time frame
30 days
2

procedure duration

surgical time measured from incision to closing

Time frame
30 days
3

blood transfusion rate

percent of patients requiring blood transfusion

Time frame
30 days
4

Emergency room visits

percent of patients presenting to emergency room at least once after surgery

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: