UrolithiasisNCT04506723
Comparison of Morphological and Radiological Data in Patients With Urolithiasis
A study testing Percutaneous Nephrolithotomy, Partial nephrectomy and Radical nephrectomy in people with Urolithiasis, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Urolithiasis
- What is being tested?
- Percutaneous Nephrolithotomy, Partial nephrectomy and Radical nephrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- 30 Apr 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
- Men and women >18 years and <45 years old;
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- 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.
Who cannot join
- 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;
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- Systemic intake of nephrotoxic drugs;
- Severe general somatic condition, making the operation impossible;
- Pregnancy.
- Urolithiasis in anamnesis;
- A history of trauma and surgical interventions on the kidneys, urinary tract, renal vessels;
- Intercurrent background;
- Non-informative biopsy.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Institute for Urology and Reproductive Health, Sechenov University.
Moscow, 119991
Dmitry Enikeev, MD, +7 925 517 79 26, enikeev-dv@1msmu.ru
About this study
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
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.
- Conditions
- Urolithiasis
- Being tested
- Percutaneous Nephrolithotomy, Partial nephrectomy, Radical nephrectomy
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous NephrolithotomyProcedure or surgery
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 nephrectomyProcedure or surgery
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 nephrectomyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Patients with urolithiasis | Experimental | Patients with confirmed urolithiasis who is assigned to PCNL. Receives: Procedure: Percutaneous Nephrolithotomy |
| Patients without urolithiasis | Active comparator | Patients with renal tumor without urolithiasis in history who is assigned to partial or radical nephrectomy due to renal tumor. Receives: Procedure: Partial nephrectomy; Procedure: Radical nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Secondary outcomes (1)
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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start30 Apr 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dmitry Enikeev, MD, PhD, I.M. Sechenov First Moscow State Medical University
- Investigators
- Dmitry Enikeev, M.D., Ph.D., Study director, Sechenov UniversityDmitry Fiev, M.D., Ph.D., Principal investigator, Sechenov University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506723
- Sponsor's protocol ID
- Stone-CL-01
- Status last verified
- Jul 2021
- First submitted
- 6 Aug 2020
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04506723
- Acronym / sponsor ID
- Stone-CL-01
- Conditions
- Urolithiasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 10 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with urolithiasis | Experimental | Procedure: Percutaneous NephrolithotomyPatients with confirmed urolithiasis who is assigned to PCNL. |
| Patients without urolithiasis | Active comparator | Procedure: Partial nephrectomy, Procedure: Radical nephrectomyPatients with renal tumor without urolithiasis in history who is assigned to partial or radical nephrectomy due to renal tumor. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous NephrolithotomyPCNL 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 or surgery | Patients with urolithiasis |
| Partial nephrectomyPartial 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 or surgery | Patients without urolithiasis |
| Radical nephrectomyNephrectomy 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 or surgery | Patients without urolithiasis |
Primary outcome
To evaluate the features of interrenal transport of contrast agent and the structural state of the renal tissue
Time frame: 1 month
The data of 3D analysis of CT of the kidneys in patients with urolithiasis
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dmitry Enikeev, M.D., Ph.D. study director
Sechenov University
Dmitry Fiev, M.D., Ph.D. principal investigator
Sechenov University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Nephrolithotomy, Partial nephrectomy and Radical nephrectomy in people with Urolithiasis, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dmitry Fiev, M.D., Ph.D. (+79265690949, fiev@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the features of interrenal transport of contrast agent and the structural state of the renal tissue (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021; AzTrials last refreshed its copy on 7 Nov 2026.