Influence of Simple Renal Cysts on Renal Function

Sponsor

Moscow State University of Medicine and Dentistry (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05134077

Collaborator

(none)

120

Enrollment

Arms

2.4

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Simple Renal Cyst Renal Function Disorder	Procedure: CT scan with contrast Radiation: Nephroscintigraphy	N/A

Detailed Description

This study is planned to include patients from S.I. Spasokukotskiy Citi Clinical Hospital with simple renal accidentally discovered cyst.

The aim of the study is to evaluate the impact of simple renal cysts on renal function and explore the correlation between cyst's size, parenchymal atrophy, and renal function.

After receiving the results, the analysis of the data obtained is carried out.

The symmetry of the function of both kidneys is analyzed
The relationship between the presence of a simple kidney cyst and a decrease in its function in comparison with a healthy kidney is analyzed.
The relationship between the maximum size of a kidney cyst and a decrease in its function in comparison with a healthy kidney is analyzed.
The relationship between the volume of the atrophied kidney parenchyma and a decrease in its function as compared with a healthy kidney is analyzed.
Correspondence of GFR indices obtained by scintigraphy and by calculation using the Schwartz formula

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Influence of Simple Renal Cysts on Renal Function: Cohort Clinical Trial.

Anticipated Study Start Date :

Feb 16, 2022

Anticipated Primary Completion Date :

Mar 8, 2022

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: kidneys with simple cysts Patients involve from Citi Clinical Hospital with simple renal accidentally discovered cyst.	Procedure: CT scan with contrast 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). Radiation: Nephroscintigraphy Nephroscintigraphy is necessary to determine the renal function
Active Comparator: contralateral kidneys without cyst Рatients involve from Citi Clinical Hospital with simple renal accidentally discovered cyst.	Procedure: CT scan with contrast 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). Radiation: Nephroscintigraphy Nephroscintigraphy is necessary to determine the renal function

Arm

Intervention/Treatment

Experimental: kidneys with simple cysts

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

Procedure: CT scan with contrast

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).

Radiation: Nephroscintigraphy

Nephroscintigraphy is necessary to determine the renal function

Active Comparator: contralateral kidneys without cyst

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

Procedure: CT scan with contrast

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).

Radiation: Nephroscintigraphy

Nephroscintigraphy is necessary to determine the renal function

Outcome Measures

Primary Outcome Measures

Renal function [1 month]
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

Secondary Outcome Measures

Ratio of cyst size and volume of atrophic renal parenchyma [1 month]
Computed tomography with contrast will be used to determine the position of renal cysts, their location, size and volume of atrophic parenchyma (cm2) are calculated

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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
Kidney and upper urinary tract surgery
Anomalies of the kidneys and upper urinary tract with impaired outflow
Calcification of the renal arteries
Renal artery stenosis
Hypertensive nephropathy
Severe concomitant diseases requiring
Chemotherapy
Long-term (more than 10 days) antibiotic therapy in the last month
Long-term (more than 7 days) use of NSAIDs in the last month
Diagnostic and therapeutic manipulations accompanied by the introduction of X-ray contrast agents
Secondarily shriveled or non-functioning kidney
Kidney hypoplasia
Accessory kidney
a decrease in GFR below normal values for a kidney without a cyst (as determined by nephroscintigraphy)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Moscow State University of Medicine and Dentistry

Investigators

Principal Investigator: Tukhtasin Mahmudov, Moscow state university of medicine and dentistry named after A.I. Evdokimov

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Moscow State University of Medicine and Dentistry

ClinicalTrials.gov Identifier:

NCT05134077

Other Study ID Numbers:

First Posted:

Nov 24, 2021

Last Update Posted:

Nov 24, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Moscow State University of Medicine and Dentistry

Simple Renal Cyst, Renal Function

Additional relevant MeSH terms:

Cysts

Kidney Diseases, Cystic

Study Results

No Results Posted as of Nov 24, 2021