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临床试验/NCT04798963
NCT04798963Unknown不适用

3D Assessment of Functional Parenchymal Volume and Split Renal Function Before and After Partial Nephrectomy

I.M. Sechenov First Moscow State Medical University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年3月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
GFR after the surgery

研究概览

简要总结

The study aims to compare pre- and postoperative 3D renal function results of patients who underwent on-clamp and off-clamp partial nephrectomy.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1. Men and women >18 years;
  • Diagnosis of unilateral renal cell carcinoma (stage T1-T3aN0M0);
  • Planned surgery: retroperitoneoscopic/laparoscopic/robotic partial nephrectomy;
  • Patients with CT of the kidneys with contrast enhancement performed according to the required protocol.

排除标准

  • Age < 18 years old or ASA> 3;
  • Solitary kidney;
  • Bilateral kidney
  • The presence of concomitant systemic pathology (DM, AH), as well as kidney disease (glomerulonephritis), which can change the state of the renal parenchyma;
  • Obstructive nephropathy
  • Systemic intake of nephrotoxic drugs;
  • Pregnancy. -

研究组 & 干预措施

Off-clamp partial nephrectomy

Other

Patients who are assigned to off-clamp partial nephrectomy.

干预措施: Off-clamp partial nephrectomy (Procedure)

On-clamp partial nephrectomy

Other

Patients who are assigned to on-clamp partial nephrectomy.

干预措施: On-clamp partial nephrectomy (Procedure)

结局指标

主要结局

GFR after the surgery

时间窗: 6 months

次要结局

  • Complication rate (Clavien-Dindo)(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dmitry Enikeev, MD, PhD

Deputy Director for Research

I.M. Sechenov First Moscow State Medical University

研究点 (1)

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