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临床试验/NCT04506723
NCT04506723Unknown不适用

Comparison of the Morphological Picture of the Renal Parenchyma With the Results of Mathematical Analysis of Intrarenal Transport of Contrast Medium in Computed Tomography in Patients With Urolithiasis

I.M. Sechenov First Moscow State Medical University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年4月30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
40
试验地点
1
主要终点
To evaluate the features of interrenal transport of contrast agent and the structural state of the renal tissue

研究概览

简要总结

The aim of the study was to compare the ultrastructural changes in the renal parenchyma with the results of postprocessing CT analysis with contrast enhancement in patients with urolithiasis.

研究设计

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •for experimental group:
  • •Men and women >18 years and <45 years old;
  • •Established diagnosis of urolithiasis that does not interfere with the processes of urodynamics (there is no expansion of the overlying urinary tract);
  • •Planned surgery - percutaneous nephrolithotripsy;
  • •Stone size up to 20 mm., Patients with multiple small two-sided stones;
  • •Patients with CT of the kidneys with contrast enhancement performed according to the required protocol.

排除标准

  • •for experimental group:
  • •Age < 18 years old or ASA> 3;
  • •With single kidney;
  • •Patients with coral stones;
  • •The presence of concomitant systemic pathology (DM, AH), as well as kidney disease (glomerulonephritis), which can change the state of the renal parenchyma;
  • •A history of injuries and surgical interventions on the kidneys, urinary tract, renal vessels;
  • •Taking nephrotropic drugs;
  • •Systemic intake of nephrotoxic drugs;
  • •Severe general somatic condition, making the operation impossible;
  • •Inclusion Criteria for control group:
  • •Men and women >18 years and <45 years old;
  • •Absence of urolithiasis in the patient's anamnesis and in his family history;
  • •Renal tumors which have undergone partial nephrectomy or nephrectomy;
  • •Patients with CT renal data with contrast enhancement, performed according to the required protocol.
  • •Exclusion Criteria for control group:
  • •Urolithiasis in anamnesis;
  • •A history of trauma and surgical interventions on the kidneys, urinary tract, renal vessels;
  • •Intercurrent background;
  • •Non-informative biopsy.

研究组 & 干预措施

Patients with urolithiasis

Experimental

Patients with confirmed urolithiasis who is assigned to PCNL.

干预措施: Percutaneous Nephrolithotomy (Procedure)

Patients without urolithiasis

Active Comparator

Patients with renal tumor without urolithiasis in history who is assigned to partial or radical nephrectomy due to renal tumor.

干预措施: Partial nephrectomy (Procedure)

Patients without urolithiasis

Active Comparator

Patients with renal tumor without urolithiasis in history who is assigned to partial or radical nephrectomy due to renal tumor.

干预措施: Radical nephrectomy (Procedure)

结局指标

主要结局

To evaluate the features of interrenal transport of contrast agent and the structural state of the renal tissue

时间窗: 1 month

The data of 3D analysis of CT of the kidneys in patients with urolithiasis

次要结局

  • To assess the features of the morphological structure of glomeruli, tubules, perivascular and interstitial spaces of renal tissue in patients with urolithiasis(2 weeks)

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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