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临床试验/NCT01720693
NCT01720693终止2 期

A Pilot Study to Examine a Novel Controlled Hypo-Perfusion Technique in Partial Nephrectomy

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2012年6月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
终止
入组人数
3
试验地点
1
主要终点
To perfect the Renal Hypoperfusion during partial nephrectomy is feasible safe and result in better renal function than complete occlusion of renal blood flow

研究概览

简要总结

Many patients who are candidates for nephron-sparing surgery, partial nephrectomy is now the standard treatment with a surgical, small, clinical T1 tumor (<7 cm). In many recent studies, partial nephrectomy provides equivalent oncologic, and superior functional, outcomes compared with the standard radical nephrectomy over the short and long term (2, 3). Partial nephrectomy techniques, whether open, laparoscopic or robotic, typically involve hilar clamping, which creates the desired bloodless operative field, allowing for more precise tumor excision and renal reconstruction. This hilar clamping eventually may lead to ischemic kidney injury which can compromise the functional outcomes of the remaining kidney.We are working now to develop a novel technique of Hypo-Perfusion by achieving partial renal arterial clamping, with the goal of completely eliminating surgical ischemia to the renal remnant.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
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

  • •Patient must be at least 18 years old scheduled for open partial nephrectomy

排除标准

  • •No prior diagnosis of renal artery disease

研究组 & 干预措施

hypoperfusion

Experimental

Hypoperfusion of the renal artery

干预措施: Hypoperfusion of renal artery (Procedure)

结局指标

主要结局

To perfect the Renal Hypoperfusion during partial nephrectomy is feasible safe and result in better renal function than complete occlusion of renal blood flow

时间窗: up to 2 weeks prior to surgery and up to 24 hrs post surgery

renal function will be measured using creatinine, eGFR, 24 hr creat clearance, and NGAL biomarker of acute kidney injury

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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