Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04506723
Other study ID # Stone-CL-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 30, 2020
Est. completion date December 31, 2021

Study information

Verified date July 2021
Source I.M. Sechenov First Moscow State Medical University
Contact Dmitry Fiev, M.D., Ph.D.
Phone +79265690949
Email fiev@mail.ru
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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
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

Locations

Country Name City State
Russian Federation Institute for Urology and Reproductive Health, Sechenov University. Moscow

Sponsors (1)

Lead Sponsor Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT04746378 - PRedictive Accuracy of Initial Stone Burden Evaluation.
Recruiting NCT05100017 - Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy Procedure N/A
Recruiting NCT04021381 - Citrate Salts for Stone-free Result After Flexible Ureterorenoscopy for Inferior Calyx Calculi Phase 3
Completed NCT02266381 - A Prospective Comparison of Fluoroscopic, Sonographic or Combined Approach for Renal Access in Percutaneous Nephrolithotomy N/A
Completed NCT01451931 - Study of Tomography of Nephrolithiasis Evaluation Phase 4
Terminated NCT01431378 - Pilot Study of Model Based Iterative Reconstruction Using 64-Slice N/A
Completed NCT02895711 - Radiation Dose of Pediatric Patients During Ureteroscopy
Completed NCT01295879 - Vitamin D Repletion in Stone Formers With Hypercalciuria Phase 4
Completed NCT05340075 - Staged Bilateral Percutaneous Nephrolithotomy
Recruiting NCT03919227 - Measurement of Resistance During UAS Insertion Procedure in RIRS N/A
Recruiting NCT03717285 - Under Direct Vision vs Under Non Direct Vision of Insertion of UAS in RIRS N/A
Completed NCT05340088 - Optimal Passive Dilation Time in Retrograde Intrarenal Surgery
Completed NCT05032287 - Medical Expulsive Therapy Post-SWL For Renal Stones N/A
Recruiting NCT05701098 - SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD) N/A
Not yet recruiting NCT04080973 - Metabolic Workup in Patients Suffering From Kidney Stone Disease and Osteopenia N/A
Terminated NCT01736358 - The Use of Intranasal Ketoralac for Pain Management (Sprix) Phase 4
Completed NCT01792765 - Management of Ureteral Calculi Using Ultrasound Guidance: A Radiation Free Approach N/A
Completed NCT06211842 - Genetic Variations That Increase the Risk for Calcium Kidney Stones: a Family-based Study
Not yet recruiting NCT02214836 - Ultrasound Imaging of Kidney Stones and Lithotripsy N/A
Not yet recruiting NCT04606758 - Fluoroscopic Guided vs US-guided Percutaneous Nephrolithotripsy for the Treatment of Stone Disease N/A