The Difference of Two Year Recurrence Rate According to Anesthetic Method During Transurethral Resection of Bladder Mass in Patients With Non-muscle Invasive Bladder Cancer: Prospective, Randomized, Clinical Phase II Study
试验速览
- 阶段
- 不适用
- 入组人数
- 289
- 试验地点
- 1
- 主要终点
- 2-year recurrence-free survival rate
研究概览
简要总结
The investigators compare the recurrence rate difference between two years after transurethral resection of the bladder tumor according to the method of anesthesia. Anesthetic methods are general anesthesia and spinal anesthesia. Assessment of recurrence is assessed by bladder endoscopy, CT, and pathological examination of surgical specimens.
详细描述
- Research Background Most of the bladder cancer (approximately 85%) has histologic features of urothelial carcinoma. Approximately 75% of the patients initially diagnosed as non-invasive bladder cancer (stage I, CIS) or submucosal stage T1 -muscle invasive bladder cancer - NMIBC). However, it has been reported that about 60% to 70% of patients experience recurrence and 20% to 30% of relapsed cancers require radical cystectomy or chemotherapy It is known to progress to high-grade or high grade cancer.
There are studies that involve surgical factors such as volatile anesthetics, narcotic analgesics, anti-body temperature, blood transfusion, and cancer recurrence. Minimizing the use of volatile anesthetics and narcotic analgesics reduces spinal anesthesia before and after surgery, It has been reported that there is a correlation with maintenance of immune cell function 2. Research hypothesis and purpose The aim of this study was to evaluate the recurrence rate, recurrence - free survival rate, and recurrence - free survival rate of non - muscle invasive bladder carcinoma in patients undergoing bladder resection. 3. Research Method
- Preoperative screening: Physical examination, Blood test, CT urography, Urine analysis, Urine culture, Urine cytology, Cystoscopy. Enforced
- Randomization on the day before surgery: 289 patients were randomly assigned to a spinal anesthesia group and a general anesthesia group 1: 1.
Urine analysis, urine culture, urine cytology, and cystoscopy were performed every 3 months up to 2 years postoperatively. CT urography performed once a year
- Follow-up procedure: Follow-up procedure according to bladder cancer standard.
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
盲法说明
Using a web site, and creating a randomized list at Sealedenvalop.com. Patients are randomly assigned to receive an anesthetic consent, and no masking is performed.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years old or older
- •Patients with suspected Ta / T1 non-muscle invasive bladder cancer
- •Patients who were not previously treated with other cancers
- •Normal range creatinine, AST, ALT patients
- •Patients with both spinal anesthesia and general anesthesia
排除标准
- •Patients with urinary tract carcinoma not invading the renal pelvis, ureter or urethra
- •Patients with cancer other than bladder cancer or a history of treatment
- •Patients with clinical evidence of muscle-invasive bladder cancer
- •Patients taking immunosuppressive drugs and immunosuppressive drugs
研究组 & 干预措施
General anesthesia
Group of general anesthesia before transurethral resection of the bladder tumor anesthesia: propopol
干预措施: Anesthesia before transurethral resection of the bladder tumor (Procedure)
General anesthesia
Group of general anesthesia before transurethral resection of the bladder tumor anesthesia: propopol
干预措施: Anesthesia (Drug)
Spinal anesthesia
Group of spinal anesthesia before transurethral resection of the bladder tumor anesthesia: bupibacaine
干预措施: Anesthesia before transurethral resection of the bladder tumor (Procedure)
Spinal anesthesia
Group of spinal anesthesia before transurethral resection of the bladder tumor anesthesia: bupibacaine
干预措施: Anesthesia (Drug)
结局指标
主要结局
2-year recurrence-free survival rate
时间窗: Follow up every 3 months until 2 years after surgery
The criteria for recurrence-free survival and recurrence of bladder cancer for 2 years postoperatively are based on pathological histology. If the recurrence is suspected in the radiological examination but pathological histological examination is difficult, the reference is based on the day of the imaging examination suspected of recurrence.
次要结局
- 2-year progression-free survival(Follow up every 3 months until 2 years after surgery)
研究者
Ja Hyeon Ku
Professor, MD., PHD.
Seoul National University Hospital