Influence of Simple Renal Cysts on Renal Function

Moscow State University of Medicine and Dentistry

Status: Unknown

Conditions: Simple Renal Cyst; Renal Function Disorder

Treatments: Radiation: Nephroscintigraphy; Procedure: CT scan with contrast

Study type: Interventional

Funder types: Other

Identifiers

NCT05134077

SRC

Details and patient eligibility

About

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

Full 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

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

kidneys with simple cysts

Experimental group

Description:

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

Treatment:

Radiation: Nephroscintigraphy

Procedure: CT scan with contrast

contralateral kidneys without cyst

Active Comparator group

Description:

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

Treatment:

Radiation: Nephroscintigraphy

Procedure: CT scan with contrast