Comparison of Morphological and Radiological Data in Patients With Urolithiasis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Urolithiasis
• Intervention / Treatment: Procedure: Percutaneous Nephrolithotomy; Procedure: Partial nephrectomy; Procedure: Radical nephrectomy

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dmitry Fiev, M.D., Ph.D.; Phone Number: +79265690949; Email: fiev@mail.ru

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119991
    • Recruiting
    • Institute for Urology and Reproductive Health, Sechenov University.
    • Contact: Dmitry Enikeev, MD; Phone Number: +7 925 517 79 26; Email: enikeev-dv@1msmu.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with urolithiasis; Patients with confirmed urolithiasis who is assigned to PCNL.	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
Active Comparator: Patients without urolithiasis; Patients with renal tumor without urolithiasis in history who is assigned to partial or radical nephrectomy due to renal tumor.	Procedure: 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; Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: I.M. Sechenov First Moscow State Medical University
• Investigators: Study Director: Dmitry Enikeev, M.D., Ph.D., Sechenov University; Principal Investigator: Dmitry Fiev, M.D., Ph.D., Sechenov University

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: August 6, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (Actual): August 10, 2020

Study Record Updates

• Last Update Posted (Actual): July 22, 2021
• Last Update Submitted That Met QC Criteria: July 21, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Calculi; Urinary Calculi; Urolithiasis
• Other Study ID Numbers: Stone-CL-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No