TFL vs MOSES Holmium Laser in the En-bloc Resection of Bladder Tumors

Официальное название

Thulium Fiber Laser (TFL) Versus MOSES Holmium Laser in the En-bloc Resection of Bladder Tumors: A Randomized Controlled Clinical Study

Обзор

The goal of this randomized clinical trial is to determine if there is difference in pathological and clinical outcomes between MOSES and TFL in the transurethral laser enucleation of bladder tumors. The main question it aims to answer is: Is there a difference in pathological and clinical outcomes between MOSES Holmium and Thulium Fiber Laser (TFL) in the transurethral laser enucleation of bladder tumors? Participants will randomized to either TFL of MOSES arm for their bladder resection procedure.

Подробное описание

An estimated 12,500 Canadians are diagnosed with bladder cancer each year. Diagnosis and treatment involve transurethral (through the urethra) resection of tumor or tissue called the TURBT procedure. This procedure yields excellent results and minimal morbidity and mortality but has a high recurrence rate, difficulties in the pathologic interpretation of the specimen (due to cautery effect), and procedure-related complications (excessive bleeding, bladder perforation, bowel injury, and inadvertent extensive injury to urethra) that may delay treatments such as chemotherapy which would further impact oncologic outcomes. With the advancement of technology, new methods of transurethral tumor removal have emerged, such as the use of laser energy. Using laser energy, the tumour is resected in one piece, whereas the TURBT approach requires breaking the tumor into pieces. This allows for better pathology analysis that can determine treatment pathways for the patient, as well as reduces the risk of complications. The standard lasers used have been the MOSES Holmium laser and the Thulium Fiber Laser (TFL).

Вмешательства

• Устройство TFL
  Participant undergoing bladder tumour resection that has been randomized to this arm.
• Устройство MOSES holmium laser
  Participant undergoing bladder tumour resection that has been randomized to this arm.

Первичные конечные точки

• Presence of muscularis propria [Срок оценки: 1 day post-procesure]
• Incidence of inconclusive pathology [Срок оценки: 1 day post-procedure]

Вторичные конечные точки (10)

• Tumor-free rate (TFR) [Срок оценки: 6 to 12 weeks post-procedure]
• Total operative time [Срок оценки: Intraoperative]
• Total procedural time [Срок оценки: Intraoperative]
• Number of recurrences [Срок оценки: 12 weeks post-procedure]
• Total blood loss [Срок оценки: 6 hours post-procedure]
• Rate of complications [Срок оценки: 4 weeks post-procedure]
• Number of inconclusive pathology [Срок оценки: 1 day post-procedure]
• Lasing time [Срок оценки: Intraoperative]
• Total energy used [Срок оценки: Intraoperative]
• Frequency and severity of peri-operative complications [Срок оценки: Intraoperative]

Критерии участия

Критерии включения

• Over 18 years of age at the time of enrollment.
• Patients presented with visual criteria suggesting bladder tumor by outpatient cystoscopy will be legible for inclusion.

Критерии исключения

• Tumors deemed not eligible for laser resection as determined by the Urologist e.g. obvious muscle-invasive or metastatic at presentation
• Synchronous either urethral tumors or upper urinary tract tumor
• History of Carcinoma in situ
• Contracted bladder

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Thunder Bay Regional Health Sciences Centre — Thunder Bay

Идентификаторы

NCT: NCT06373419 · RP-1007

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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