Influence of Simple Renal Cysts on Renal Function

NCT05134077 | Unknown

• 1 other identifier: SRC
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, cohort, randomized clinical trial examining the effect of simple renal cysts on renal function.

Conditions

Simple Renal Cyst; Renal Function Disorder

Keywords

Simple Renal Cyst, Renal Function

Outcome Measures

Primary Outcomes (1)

• Renal function

  Glomerular filtration rate (GFR, ml/min/1.73 m2) is a test used to check how well the kidneys are working. Specifically, it estimates how much blood passes through the glomeruli each minute. A GFR of 60 or higher is in the normal range. A GFR below 60 may mean kidney disease. A GFR of 15 or lower may mean kidney failure. The measurement of the glomerular filtration rate will be measured according to the results of the blood test and the results of nephroscintigraphy

  1 month

Secondary Outcomes (1)

• Ratio of cyst size and volume of atrophic renal parenchyma

  1 month

Study Arms (2)

kidneys with simple cysts

EXPERIMENTAL

Patients involve from Citi Clinical Hospital with simple renal accidentally discovered cyst.

Procedure: CT scan with contrast; Radiation: Nephroscintigraphy

contralateral kidneys without cyst

ACTIVE COMPARATOR

Рatients involve from Citi Clinical Hospital with simple renal accidentally discovered cyst.

Procedure: CT scan with contrast; Radiation: Nephroscintigraphy

Interventions

CT scan with contrast PROCEDURE

CT scan with contrast is necessary to determine the position of renal cysts, their location, and size (determine volume of atrophic parenchyma will be calculated).

contralateral kidneys without cyst; kidneys with simple cysts

Nephroscintigraphy RADIATION

Nephroscintigraphy is necessary to determine the renal function

contralateral kidneys without cyst; kidneys with simple cysts

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with simple kidney cyst Bosniak 1-2
• Normal blood creatinine values

You may not qualify if:

• Impossibility of performing CT with intravenous contrast enhancement.
• Bosniak 3-4
• CKD
• Bilateral cysts
• Multiple renal cysts
• Sinus cysts
• Cysts with a max size less than 2 cm.
• Single kidney
• Chronic kidney disease and conditions associated with the potential decrease of kidney function
• Glomerulonephritis
• Chronic pyelonephritis
• Amyloidosis
• Diabetes
• Autoimmune diseases
• Urolithiasis

Sponsors & Collaborators

• Moscow State University of Medicine and Dentistry: lead

MeSH Terms

Interventions

Contrast Media

Intervention Hierarchy (Ancestors)

Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Tukhtasin Mahmudov

  Moscow state university of medicine and dentistry named after A.I. Evdokimov

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vigen Malkhasyan

CONTACT

+7(909) 644-16-88; vigenmalkhasyan@gmail.com

Sergey Sukhikh

CONTACT

+7(985) 307-74-50; docsukhikh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We present a cohort study of patients with renal cysts (the first group - kidneys with cysts, the second group - kidneys without cysts in the studied patients). All patients will undergo contrast-enhanced CT of the urinary system (volume of atrophic parenchyma will be calculated), as well as nephroscintigraphy.

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: November 24, 2021
• Study Start: February 16, 2022
• Primary Completion: March 8, 2022
• Study Completion: May 1, 2022
• Last Updated: November 24, 2021

Record last verified: 2021-11