Набор скоро начнётся NCT07655284

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

Фаза III С лечением Bladder Cancer Requiring Cystectomy Ureteral Stents

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: ureteral stents, no ureteral stent.
Кому может быть актуально: Состояния в реестре: Bladder Cancer Requiring Cystectomy, Ureteral Stents. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Бразилия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

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

Обзор

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

Post-operative readmission rate [Срок оценки: 30-days after surgery]

Вторичные конечные точки (8)

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

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет