Influence of Simple Renal Cysts on Renal Function

Renal Function Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05134077
• Other study ID #: SRC
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 16, 2022
• Est. completion date: May 1, 2022

Study information

• Verified date: November 2021
• Source: Moscow State University of Medicine and Dentistry
• Contact: Vigen Malkhasyan
• Phone: +7(909) 644-16-88
• Email: vigenmalkhasyan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

1. The symmetry of the function of both kidneys is analyzed

2. The relationship between the presence of a simple kidney cyst and a decrease in its function in comparison with a healthy kidney is analyzed.

3. The relationship between the maximum size of a kidney cyst and a decrease in its function in comparison with a healthy kidney is analyzed.

4. The relationship between the volume of the atrophied kidney parenchyma and a decrease in its function as compared with a healthy kidney is analyzed.

5. Correspondence of GFR indices obtained by scintigraphy and by calculation using the Schwartz formula

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: May 1, 2022
• Est. primary completion date: March 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cysts
• Renal Function Disorder
• Simple Renal Cyst

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Moscow State University of Medicine and Dentistry

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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