Renal Functional Reserve Change of Precise Segmental Versus Complete Renal Arterial Clamping During Laparoscopic Partial Nephrectomy for Clinical T1 Renal Cell Carcinoma
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Renal Functional Reserve change
研究概览
简要总结
Renal functional reserve may be better in patients with clinical T1 renal cell carcinoma(RCC) undergoing laparoscopic partial nephrectomy with precise segmental renal artery clamping than those with complete renal arterial clamping.
详细描述
Renal functional reserve (RFR) describes the capacity of the intact nephron mass to increase glomerular filtration rate(GFR) from baseline in response to stimuli (e.g., protein load).We hypothesized that renal functional reserve may be better in patients with clinical T1 renal cell carcinoma(RCC) undergoing laparoscopic partial(LPN) nephrectomy with precise segmental renal artery clamping than those with complete renal arterial clamping.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Age ≥18 2.Estimated GFR >30 mL/min/1.73m2 3.Anticipated intraoperative warm ischemic time ≤30 min 4.Subjects who signed informed consent forms
排除标准
- •Allergy to iothalamate, shellfish or iodine
- •Use of metformin or amiodarone
- •intraoperative warm ischemic time >30 min
- •Inability to maintain a stable regimen of medications which affect GFR for > one week prior to participation (e.g. non-steroidal anti-inflammatory drugs, angiotensin converting enzyme inhibitors, angiotensin receptor blockers)
- •Use of medications which directly affect elimination of creatinine (e.g. cimetidine and trimethoprim)
- •Acute exacerbation of asthma or chronic obstructive pulmonary disease within 3 months requiring hospitalization or oral steroid therapy
- •Inadequate intravenous access
- •Severe anemia (Hct <21%)
- •Acute kidney injury (rise in creatinine to ≥1.5 times the previous baseline or by ≥ 0.3 mg/dL on most recent labs prior to enrollment)
- •History of contrast-induced nephropathy
- •Hyperthyroidism
- •Pheochromocytoma
- •Sickle cell disease
- •Urinary retention or incontinence
- •Status post organ transplant
- •Pregnancy or active breast feeding
- •Cognitive impairment with inability to give consent
- •Institutionalized status
研究组 & 干预措施
precise segmental clamping
These participants with clinical T1 renal cell carcinoma(RCC) undergo precise segmental renal arterial clamping during laparoscopic partial nephrectomy.
干预措施: precise segmental renal arterial clamping (Procedure)
precise segmental clamping
These participants with clinical T1 renal cell carcinoma(RCC) undergo precise segmental renal arterial clamping during laparoscopic partial nephrectomy.
干预措施: laparoscopic partial nephrectomy (Procedure)
complete clamping
These participants with clinical T1 renal cell carcinoma(RCC) undergo complete renal arterial clamping during laparoscopic partial nephrectomy.
干预措施: laparoscopic partial nephrectomy (Procedure)
结局指标
主要结局
Renal Functional Reserve change
时间窗: 3 month after surgery.
Change in renal functional reserve after laparoscopic partial nephrectomy
次要结局
未报告次要终点
研究者
ou tongwen
chairman of urology
Xuanwu Hospital, Beijing