Thulium Fiber Laser (TFL) Versus MOSES Holmium Laser in the En-bloc Resection of Bladder Tumors: A Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Incidence of inconclusive pathology
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Incidence of inconclusive pathology
时间窗: 1 day post-procedure
Incidence of inconclusive pathology due to specimen artifact
Presence of muscularis propria
时间窗: 1 day post-procesure
Presence of muscularis propria (bladder muscle cells) in the pathology sample of the bladder tumour
次要结局
- Total procedural time(Intraoperative)
- Total blood loss(6 hours post-procedure)
- Total operative time(Intraoperative)
- Lasing time(Intraoperative)
- Tumor-free rate (TFR)(6 to 12 weeks post-procedure)
- Rate of complications(4 weeks post-procedure)
- Number of recurrences(12 weeks post-procedure)
- Number of inconclusive pathology(1 day post-procedure)
- Total energy used(Intraoperative)
- Frequency and severity of peri-operative complications(Intraoperative)
研究者
Ahmed Zakaria Ahmed
Urologist
Thunder Bay Regional Health Research Institute