Influence of Simple Renal Cysts on Renal Function

NCT ID: NCT05134077

Last Updated: 2021-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-16

Study Completion Date

2022-05-01

Brief Summary

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

Detailed Description

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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

Conditions

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Simple Renal Cyst Renal Function Disorder

Keywords

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Simple Renal Cyst, Renal Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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kidneys with simple cysts

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

Group Type EXPERIMENTAL

CT scan with contrast

Intervention Type PROCEDURE

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).

Nephroscintigraphy

Intervention Type RADIATION

Nephroscintigraphy is necessary to determine the renal function

contralateral kidneys without cyst

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

Group Type ACTIVE_COMPARATOR

CT scan with contrast

Intervention Type PROCEDURE

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).

Nephroscintigraphy

Intervention Type RADIATION

Nephroscintigraphy is necessary to determine the renal function

Interventions

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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).

Intervention Type PROCEDURE

Nephroscintigraphy

Nephroscintigraphy is necessary to determine the renal function

Intervention Type RADIATION

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Moscow State University of Medicine and Dentistry

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tukhtasin Mahmudov

Role: PRINCIPAL_INVESTIGATOR

Moscow state university of medicine and dentistry named after A.I. Evdokimov

Central Contacts

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Vigen Malkhasyan

Role: CONTACT

Phone: +7(909) 644-16-88

Email: [email protected]

Sergey Sukhikh

Role: CONTACT

Phone: +7(985) 307-74-50

Email: [email protected]

Other Identifiers

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SRC

Identifier Type: -

Identifier Source: org_study_id