Clinical trial NCT05134077: Influence of Simple Renal Cysts on Renal Function
Official title: Influence of Simple Renal Cysts on Renal Function: Cohort Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Simple Renal Cyst
Renal Function Disorder
Keywords: Simple Renal Cyst, Renal Function
Lead sponsor: Moscow State University of Medicine and Dentistry
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: DIAGNOSTIC

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.

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

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)

Primary outcomes:
measure: Renal function
timeFrame: 1 month
Secondary outcomes:
measure: Ratio of cyst size and volume of atrophic renal parenchyma
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Moscow state university of medicine and dentistry named after A.I. Evdokimov
name: Tukhtasin Mahmudov
role: PRINCIPAL_INVESTIGATOR
References: