Influence of Simple Renal Cysts on Renal Function

Study Overview
=================
Brief Summary
-----------------
This is a prospective, cohort, randomized clinical trial examining the effect of simple renal cysts on renal function.

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

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

Conditions
-----------------
Simple Renal Cyst, Renal Function Disorder

Intervention / Treatment
-----------------
* Procedure: CT scan with contrast
* Radiation: Nephroscintigraphy


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of cyst size and volume of atrophic renal parenchyma | 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 | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Simple Renal Cyst, Renal Function