Comparison of Morphological and Radiological Data in Patients With Urolithiasis

Urolithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04506723
• Other study ID #: Stone-CL-01
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2021
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: Dmitry Fiev, M.D., Ph.D.
• Phone: +79265690949
• Email: fiev[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria for experimental group:

1. Men and women >18 years and <45 years old;

2. Established diagnosis of urolithiasis that does not interfere with the processes of urodynamics (there is no expansion of the overlying urinary tract);

3. Planned surgery - percutaneous nephrolithotripsy;

4. Stone size up to 20 mm., Patients with multiple small two-sided stones;

5. Patients with CT of the kidneys with contrast enhancement performed according to the required protocol.

Exclusion Criteria for experimental group:

1. Age < 18 years old or ASA> 3;

2. With single kidney;

3. Patients with coral stones;

4. The presence of concomitant systemic pathology (DM, AH), as well as kidney disease (glomerulonephritis), which can change the state of the renal parenchyma;

5. A history of injuries and surgical interventions on the kidneys, urinary tract, renal vessels;

6. Taking nephrotropic drugs;

7. Systemic intake of nephrotoxic drugs;

8. Severe general somatic condition, making the operation impossible;

9. Pregnancy.

Inclusion Criteria for control group:

1. Men and women >18 years and <45 years old;

2. Absence of urolithiasis in the patient's anamnesis and in his family history;

3. Renal tumors which have undergone partial nephrectomy or nephrectomy;

4. Patients with CT renal data with contrast enhancement, performed according to the required protocol.

Exclusion Criteria for control group:

1. Urolithiasis in anamnesis;

2. A history of trauma and surgical interventions on the kidneys, urinary tract, renal vessels;

3. Intercurrent background;

4. Non-informative biopsy.

Related Conditions & MeSH terms

• Urinary Calculi
• Urolithiasis

Intervention

Procedure:
• Percutaneous Nephrolithotomy
PCNL will be carried out in accordance with the standards and capabilities of the medical center. After the procedure pathomorphological data of the renal parenchyma will be assessed
• Partial nephrectomy
Partial nephrectomy will be carried out in accordance with the standards and capabilities of the medical center. After the procedure pathomorphological data of the renal parenchyma will be assessed
• Radical nephrectomy
Nephrectomy will be carried out in accordance with the standards and capabilities of the medical center. After the procedure pathomorphological data of the renal parenchyma will be assessed

Locations

Country	Name	City	State
Russian Federation	Institute for Urology and Reproductive Health, Sechenov University.	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the features of interrenal transport of contrast agent and the structural state of the renal tissue	The data of 3D analysis of CT of the kidneys in patients with urolithiasis	1 month
Secondary	To assess the features of the morphological structure of glomeruli, tubules, perivascular and interstitial spaces of renal tissue in patients with urolithiasis	The assessment will be based on intraoperative biopsy	2 weeks