NCT04506723

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 10, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

1.7 years

First QC Date

August 6, 2020

Last Update Submit

July 21, 2021

Conditions

Urolithiasis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • To assess the features of the morphological structure of glomeruli, tubules, perivascular and interstitial spaces of renal tissue in patients with urolithiasis

    2 weeks

Study Arms (2)

Patients with urolithiasis

EXPERIMENTAL

Patients with confirmed urolithiasis who is assigned to PCNL.

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.

Procedure: Partial nephrectomyProcedure: Radical nephrectomy

Interventions

Percutaneous NephrolithotomyPROCEDURE

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 with urolithiasis
Partial nephrectomyPROCEDURE

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

Patients without urolithiasis
Radical nephrectomyPROCEDURE

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

Patients without urolithiasis

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.
  • Urolithiasis in anamnesis;
  • A history of trauma and surgical interventions on the kidneys, urinary tract, renal vessels;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Urology and Reproductive Health, Sechenov University.

Moscow, 119991, Russia

RECRUITING

MeSH Terms

Conditions

Urolithiasis

Interventions

Nephrolithotomy, Percutaneous

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

LaparoscopyEndoscopyMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Dmitry Enikeev, M.D., Ph.D.

    Sechenov University

    STUDY DIRECTOR

  • Dmitry Fiev, M.D., Ph.D.

    Sechenov University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+79265690949fiev@mail.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director for Research

Study Record Dates

First Submitted

August 6, 2020

First Posted

August 10, 2020

Study Start

April 30, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

July 22, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)