The Value of Immediate Post-operative Intravesical Epirubicin Instillation in Intermediate and High Risk Non Muscle Invasive Bladder Cancer (NMIBC): A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Recurrence, progression and/or death from cancer.
研究概览
简要总结
The aim of the study is to test the value of immediate post-operative intravesical instillation of epirubicin in patients with intermediate and high risk non muscle invasive bladder cancer (NMIBC).
详细描述
Preoperative evaluation will be carried out in the form of routine laboratory investigations, abdominal and pelvic US and computed tomography (CT) or magnetic resonance imaging (MRI) abdomen and pelvis if necessary. Then, the patients will be subjected to complete TURBT.
The patients will be transferred to the recovery room, careful monitoring of the patients will be carried out for the 1st 30 min, and then after confirming the patient eligibility for enrollment in the study by exclusion of cases with hematuria and suspicious bladder perforation, patients will be enrolled randomly into one of the two groups. The randomization process will be performed using computer-generated simple random tables in a 1:1 ratio or by the method of closed envelopes.
The 1st group will not receive intravesical instillation of epirubicin -Placebo-(control group), and, the 2nd group will receive intravesical instillation of epirubicin 50 mg in 50 ml saline 0.9% (study group) with clamping of the urethral catheter for 1 hour after instillation and during this period the patients are monitored for local or systemic adverse events (acute abdomen, chills, fever, hot flushes, abdominal rigidity, hematuria after de-clamping of the catheter).
Evaluation:
Intraoperative and early postoperative parameters of interest will be recorded and compared between the two groups like EUA findings, tumor characteristics during cystoscopy as the tumor size, site, shape, number, suspicion of CIS, post instillation adverse events, cytology and biopsy results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •Ability to give informed consent.
- •Patients with primary or recurrent papillary Non muscle invasive bladder cancer (NMIBC).
- •Complete transurethral resection of bladder tumor(TURBT).
- •Normal cardiac, hematological, and renal functions.
- •Patients with intermediate and high risk NMIBC confirmed by histopathology.
排除标准
- •Inability to give informed consent.
- •Patients with history of previous radiotherapy or systemic chemotherapy.
- •Patients suffering from immuno-deficiency or other malignancies.
- •Patients with history of hypersensitivity reaction to epirubicin.
- •Examination under anesthesia (EUA) reveals palpable bladder mass.
- •Patients with primary, single, less than 1cm papillary bladder tumor (high likelihood of being low risk).
- •Suspicion of perforation of the bladder during TURBT.
- •Patients who develop hematuria in the recovery room necessitating continuous bladder wash or endoscopic haemostasis.
- •Patients with proven low risk NMIBC on histopathology.
研究组 & 干预措施
Study group(Epirubicin)
in this arm -study group(Epirubicin)- : patients will receive immediate intravesical instillation of 50 mg of epirubicin in 50 ml of saline 0.9 % after 30 min after compete transurethral resection of bladder tumor
干预措施: Epirubicin (Drug)
结局指标
主要结局
Recurrence, progression and/or death from cancer.
时间窗: within the 1st year after complete Transurethral resection of bladder tumor
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(within 1st 24 hours following intravesical instillation of the used drug)
研究者
Amr Abdel-Lateif El-Sawy
Resident in Urology, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt
Mansoura University