NCT02951078Unknown3 期
A Study of Comparing Effects of Thulium Laser en Bloc Resection and Electrical Transurethral Resection of the Non-muscle Invasive Bladder Cancer
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine0 个研究点目标入组 172 人开始时间: 2017年1月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 172
- 主要终点
- The residual rate of tumor in the second operation of the two surgical methods
研究概览
简要总结
This study is to verify the short-term efficacy and long-term prognosis of thulium laser resection compared with conventional transurethral resection of non-muscular invasive bladder cancer. Half of participants will receive thulium laser resection of bladder cancer, while the other half will receive electrical transurethral resection of bladder cancer.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Pathological or histological diagnosis of primary non-muscle invasive bladder urothelial carcinoma (TaTisT1);
- •Imaging examinations showed the bladder muscle has not been affected, no lymph node metastasis or distant metastasis;
- •Patients who agree to TURBT surgery, and will be effected to the postoperative follow-up treatment such as conventional infusion after the operation;
- •Function of main organs (heart, liver, lung, kidney) should be normal, PS score 0-2;
- •Bladder capacity≥ 200ml.
排除标准
- •Find distant metastasis ,infiltration of the surrounding organs or relapse before operation.Metastatic bladder cancer or other cancers involve the bladder;
- •Received chemotherapy or BCG perfusion therapy in the nearly 3 months;
- •Patients who can not tolerate the serious side effects during the bladder perfusion treatment process (bladder irritation and other symptoms);
- •Patients during pregnancy ,critical care patients and patients who have other cases of surgical contraindications.Such as serious cardiovascular disease,coagulation abnormalities,non-transitional epithelial tumors( such as adenocarcinoma and squamous cell carcinoma),acute cystitis,can not be supine because of spinal deformity,untreated urethral stricture.
结局指标
主要结局
The residual rate of tumor in the second operation of the two surgical methods
时间窗: 2 years
次要结局
未报告次要终点
研究者
Liu Haitao
Chief physician
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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