Comparison of Morphological and Radiological Data in Patients With Urolithiasis

NCT ID: NCT04506723

Last Updated: 2021-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-30

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Urolithiasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Patients with urolithiasis

Patients with confirmed urolithiasis who is assigned to PCNL.

Group Type EXPERIMENTAL

Percutaneous Nephrolithotomy

Intervention Type PROCEDURE

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

Patients without urolithiasis

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

Group Type ACTIVE_COMPARATOR

Partial nephrectomy

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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.


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

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.


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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role lead

Responsible Party

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Dmitry Enikeev, MD, PhD

Deputy Director for Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dmitry Enikeev, M.D., Ph.D.

Role: STUDY_DIRECTOR

Sechenov University

Dmitry Fiev, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Sechenov University

Locations

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Institute for Urology and Reproductive Health, Sechenov University.

Moscow, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Dmitry Fiev, M.D., Ph.D.

Role: CONTACT

+79265690949

Facility Contacts

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Dmitry Enikeev, MD

Role: primary

+7 925 517 79 26

Other Identifiers

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Stone-CL-01

Identifier Type: -

Identifier Source: org_study_id

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