- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04506723
Comparison of Morphological and Radiological Data in Patients With Urolithiasis
July 21, 2021 updated by: Dmitry Enikeev, MD, PhD, I.M. Sechenov First Moscow State Medical University
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dmitry Fiev, M.D., Ph.D.
- Phone Number: +79265690949
- Email: fiev@mail.ru
Study Locations
-
-
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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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients with urolithiasis
Patients with confirmed urolithiasis who is assigned to PCNL.
|
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.
|
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
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
Time Frame: 1 month
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The data of 3D analysis of CT of the kidneys in patients with urolithiasis
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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
Time Frame: 2 weeks
|
The assessment will be based on intraoperative biopsy
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2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Dmitry Enikeev, M.D., Ph.D., Sechenov University
- Principal Investigator: Dmitry Fiev, M.D., Ph.D., Sechenov University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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