Evaluation of Thulium Laser Endoscopic En-bloc Resection Versus Conventional Trans-urethral En-bloc Resection of Primary Non-muscle Invasive Bladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Recurrence free survival rate
研究概览
简要总结
The goal of this clinical trial is to know if thulium laser works to treat non-muscle invasive bladder cancer "NMIBC" efficiently in comparison to classical trans-urethral resection "TURBT". It will also learn about the safety of this technique. The main questions it aims to answer are:
Does thulium laser lower the incidence of recurrence to participants with non- muscle invasive bladder cancer? What complications do participants have when using this technique? Investigators will compare thulium laser en-bloc resection to a classical trans-urethral en-bloc resection of bladder tumor
Participants will:
Do thulium laser en-bloc resection or trans-urethral en-bloc resection And will be classified to risk group according to European association of urology guidelines and followed up accordingly.
详细描述
The conventional transurethral resection of bladder tumor (TURBT) is the most common strategy for NMIBC and it is recommended by the guidelines. However, the TURBT has a complication rate of ~4-6%, of which urinary tract infections and significant haematuria are most common.
In some cases, major complications including obturator nerve reflex (ONR) and bladder perforation could occur. To overcome these drawbacks, lasers including holmium YAG and thulium YAG were introduced. Several studies have suggested the superior safety of Thulium laser resection of bladder tumors (TmLRBT) compared with conventional TURBT.
The TmLRBT is increasingly used in the treatment of NMIBC recently, but whether it can provide better cancer control than TURBT is still unclear.
Previous studies have compared the recurrence rates of these two therapies but no significant difference was detected.However, in all these studies, intravesical therapies were conducted using epirubicin or mitomycin C, instead of bacillus Calmette-Guérin (BCG), which is superior for preventing the recurrence of NMIBC.
En-bloc resection of bladder tumor (ERBT) was first described by Kawada et al. in 1997 and has been used by urologists since then. The main advantage of ERBT is that it can resect and extract the entire tumor with a high-quality specimen rather than piecemeal, overcoming some of the short comings of TURBT.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age : adults and older adults
- •patients with bladder transitional cell carcinoma
- •Imaging examinations showed small bladder mass < 3 cm and the bladder muscle has not been affected, no lymph node metastasis or distant metastasis;
- •Primary tumor
排除标准
- •Large bladder mass > 3 cm measured by CT urography
- •Recurrent tumor
- •Patients that confirmed post operative histopathology with muscle-invasive bladder transitional cell carcinoma
- •Received previous chemotherapy or radiotherapy
- •Other pathological types of bladder cancer
研究组 & 干预措施
Thulium laser "TmLRBT"
Participants recieved thulium laser en-bloc resection of bladder mass
干预措施: Thulium laser en-bloc resection of bladder mass (Procedure)
Trans-Urethral resection "TURBT"
Participants recieved trans-urethral en-bloc resection of bladder mass
干预措施: Trans-urethral en-bloc resection of bladder mass (Procedure)
结局指标
主要结局
Recurrence free survival rate
时间窗: 12 months
Number of participants with recurrence free survival during scheduled follow up protocol according to European association of urology guidelines
Local recurrence rate
时间窗: 12 months
Number of participants with absence of local recurrence on the site of resection during follow up cystoscopy protocol
次要结局
- Peri-operative complications(Intra operative to 1 week post operative duration)
研究者
Samuel Fayek Tawfeles Ebskharoun
Principal investigator
Helwan University