Impact of Anesthesia Modality on Recurrence and Progression in High-Risk Non-Muscle Invasive Bladder Cancer: A Randomized Controlled Trial Comparing Spinal Versus General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 370
- 试验地点
- 1
- 主要终点
- Time to recurrence in high risk NMIBC patients
研究概览
简要总结
To demonstrate the superior efficacy of spinal anesthesia (SA) versus general anesthesia (GA) according to the delay of time to recurrence in high-risk NMIBC patients up to Week 104 after 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥40 years for male subjects or postmenopausal female subjects
- •ECOG performance status 0-2
- •Patients with suspected or newly diagnosed UBUC
- •ASA I or II
- •Patients with any other adequately treated Stage I or II cancer except UC, from which the subject has been disease free for 5 years
- •Adequate renal function, defined as a serum creatinine (Cre) concentration ≤ the institutional ULN
- •Adequate hepatic function, defined as total bilirubin ≤ the institutional ULN and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ the institutional upper limit of normal (ULN)
排除标准
- •Patients with prior or concurrent UC involving the renal pelvis, ureter or urethra
- •Patients with clinical evidence of MIBC or mUC
- •Immunocompromised or immunosuppressed patients
- •Patients with chronic use of anti-inflammatory agents or beta-blockers
- •Patients with difficult airways or other significant cardiovascular comorbidities (severe aortic stenosis, significant pulmonary disease, CHF) who are intolerant to GA
- •Patients with elevated intracranial pressure (ICP), primarily due to intracranial mass and trauma or infection at the site of SA
- •Patients with a serious uncontrolled medical disorder (e.g., trauma, fracture) or active infection that would impair their ability to receive spinal or GA
- •Patients with known allergies to propofol, fentanyl, sevoflurane, or bupivacaine
- •Subjects with a known history or family history of malignant hyperthermia
- •Subjects with bleeding diathesis
研究组 & 干预措施
General Anesthesia
干预措施: General Anesthesia (Procedure)
Spinal Anesthesia
干预措施: Spinal Anesthesia (Procedure)
结局指标
主要结局
Time to recurrence in high risk NMIBC patients
时间窗: From date of TURBT (Study Day 0) until documented recurrence or last follow-up, up to 104 weeks
The time to recurrence is defined as the number of days from TURBT to the day on which the subject presents with gross hematuria, positive urine cytology, all-risk bladder tumor relapse or newly diagnosed upper tract UC with pathological confirmation, radiographically detected tumor metastasis, or cancer-specific death beyond 90 days after diagnosis, whichever occurs first.
次要结局
- Time to event in high-risk NMIBC patients up to Week 104(From date of TURBT (Study Day 0) until documented recurrence or last follow-up, up to 104 weeks)
研究者
National Taiwan University Clinical Trial Center
Director, Department of Urology at National Taiwan University Hospital
National Taiwan University Hospital