Comparison of Morphological and Radiological Data in Patients With Urolithiasis
Primary Purpose
Urolithiasis
Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Percutaneous Nephrolithotomy
Partial nephrectomy
Radical nephrectomy
Sponsored by
About this trial
This is an interventional basic science trial for Urolithiasis
Eligibility Criteria
Inclusion Criteria 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.
Exclusion Criteria 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;
- Pregnancy.
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.
Sites / Locations
- Institute for Urology and Reproductive Health, Sechenov University.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Patients with urolithiasis
Patients without urolithiasis
Arm Description
Patients with confirmed urolithiasis who is assigned to PCNL.
Patients with renal tumor without urolithiasis in history who is assigned to partial or radical nephrectomy due to renal tumor.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04506723
First Posted
August 6, 2020
Last Updated
July 21, 2021
Sponsor
I.M. Sechenov First Moscow State Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04506723
Brief Title
Comparison of Morphological and Radiological Data in Patients With Urolithiasis
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 30, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
I.M. Sechenov First Moscow State Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urolithiasis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with urolithiasis
Arm Type
Experimental
Arm Description
Patients with confirmed urolithiasis who is assigned to PCNL.
Arm Title
Patients without urolithiasis
Arm Type
Active Comparator
Arm Description
Patients with renal tumor without urolithiasis in history who is assigned to partial or radical nephrectomy due to renal tumor.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Nephrolithotomy
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Partial nephrectomy
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Radical nephrectomy
Intervention Description
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
Primary Outcome Measure Information:
Title
To evaluate the features of interrenal transport of contrast agent and the structural state of the renal tissue
Description
The data of 3D analysis of CT of the kidneys in patients with urolithiasis
Time Frame
1 month
Secondary Outcome Measure Information:
Title
To assess the features of the morphological structure of glomeruli, tubules, perivascular and interstitial spaces of renal tissue in patients with urolithiasis
Description
The assessment will be based on intraoperative biopsy
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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.
Exclusion Criteria 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;
Pregnancy.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dmitry Fiev, M.D., Ph.D.
Phone
+79265690949
Email
fiev@mail.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dmitry Enikeev, M.D., Ph.D.
Organizational Affiliation
Sechenov University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dmitry Fiev, M.D., Ph.D.
Organizational Affiliation
Sechenov University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Urology and Reproductive Health, Sechenov University.
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dmitry Enikeev, MD
Phone
+7 925 517 79 26
Email
enikeev-dv@1msmu.ru
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Morphological and Radiological Data in Patients With Urolithiasis
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