A Phase III Multi-Institutional Randomized Clinical Trial: Effect of Type of Ischemia - Warm vs Cold During Partial Nephrectomy - on Renal Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 8
- 主要终点
- Creatinine clearance at 1 year
研究概览
简要总结
RATIONALE: Warm ischemia is the clamping of blood vessels without cooling the kidney. Cold ischemia is the clamping of blood vessels with kidney cooling. It is not yet known whether warm ischemia is more effective than cold ischemia in patients undergoing surgery for stage I kidney cancer.
PURPOSE: This randomized phase III trial is studying warm ischemia to see how well it works compared with cold ischemia during surgery in treating patients with stage I kidney cancer.
详细描述
OBJECTIVES:
Primary
- Determine the effect of warm ischemia during partial nephrectomy on long-term renal function in patients with solitary stage I renal cortical tumor and normal contralateral kidney.
Secondary
- Determine to what degree the contralateral kidney compensates for the damage inflicted on the operated kidney during surgery.
- Determine the 1-year disease-specific and overall survival of these patients.
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
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of solitary renal cortical tumor
- •Tumor size ≤ 4 cm
- •Candidate for open partial nephrectomy
- •Expected ischemia time < 45 minutes
- •Normal renal function, defined as glomerular filtration rate (GFR) > 60 mL/min
- •No evidence of distant metastasis
- •No evidence of local invasion of adjacent structures, including the adrenal gland
- •No evidence of tumor extension into the renal venous system
- •No evidence of ureteral obstruction on MAG-3 renal scan
- •No family history of renal cancer
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0
- •Life expectancy > 5 years
- •No prior malignancy, except for non-melanomatous skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Not specified
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients undergo warm ischemia followed by partial nephrectomy.
干预措施: warm ischemia procedure (Procedure)
Arm II
Patients undergo cold ischemia followed by partial nephrectomy.
干预措施: cold ischemia procedure (Procedure)
结局指标
主要结局
Creatinine clearance at 1 year
时间窗: at 1 year after nephrectomy.
Estimated glomerular filtration rate (GFR)
时间窗: at 1 year after nephrectomy.
次要结局
- Evidence of local or metastatic recurrence(at 1 year after nephrectomy.)
- Cancer-specific survival(at 1 year after nephrectomy.)
- Overall survival(at 1 year after nephrectomy.)