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

12. juni 2026 opdateret af: Timothy Clinton, Brigham and Women's Hospital

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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

190

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Brasilien
    • São Paulo
      • São Paulo, São Paulo, Brasilien, 01246-000
  • Forenede Stater
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: ureteral stents placed at time of cystectomy
standard of care ureteral stent placement at time of radical cystectomy (control arm)
Enhed: ureteral stents
standard of care single-J externalized ureteral stents to be placed at time of radical cystectomy
Eksperimentel: stent-free, no stent placement at time of cystectomy
forgo ureteral stent placement at time of radical cystectomy (intervention arm)
Enhed: no ureteral stent
no ureteral stents used at time of radical cystectomy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Post-operative readmission rate
Tidsramme: 30-days after surgery
percent of patients re-admitted
30-days after surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
length of stay
Tidsramme: 30 days
index hospitalization (days after surgery until discharge, excluding pre-admission if applicable)
30 days
procedure duration
Tidsramme: 30 days
surgical time measured from incision to closing
30 days
blood transfusion rate
Tidsramme: 30 days
percent of patients requiring blood transfusion
30 days
Emergency room visits
Tidsramme: 30 days
percent of patients presenting to emergency room at least once after surgery
30 days
patient reported pain on analog scale
Tidsramme: 30 days
analog 0 to 10 scale
30 days
ureteral stricture rate
Tidsramme: 30 days
percent of patients developing ureteral stricture requiring intervention (e.g. nephrostomy tube placement)
30 days
urine leak rate
Tidsramme: 30 days
percent of patients developing urine leak requiring intervention (e.g. interventional radiology procedure)
30 days
pyelonephritis rate
Tidsramme: 30 days
percent of patients developing of urinary tract infection (defined by clinical sequelae of infection in setting of positive urinalysis requiring treatment with antibiotics)
30 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Brigham and Women's Hospital

Efterforskere

  • Ledende efterforsker: Timothy N Clinton, MD, Brigham and Women's Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

30. juni 2029

Studieafslutning (Anslået)

31. august 2029

Datoer for studieregistrering

Først indsendt

12. juni 2026

Først indsendt, der opfyldte QC-kriterier

12. juni 2026

Først opslået (Faktiske)

17. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2025P002187

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

As part of IRB approval of the study decision was for privacy policy that only aggregated data would be intended to be shared outside the institutional system and any IPD would be solely stored on HIPAA compliant servers at the facility. De-identified or aggregated data would be permitted to be shared so long as subjects could not be identified.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med ureteral stents

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Betingelser

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