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Measurement of Renal Functional Reserve Change In Patients With SRC Before and After Laparoscopic Deroofing

Measurement of Renal Functional Reserve Change In Patients With Simple Renal Cysts Before and After Laparoscopic Deroofing

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03259594
Enrollment
200
Registered
2017-08-23
Start date
2018-03-01
Completion date
2021-12-31
Last updated
2020-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Simple Renal Cyst

Keywords

Renal functional reserve, Simple renal cysts, Laparoscopic deroofing

Brief summary

Renal functional reserve may be improved in patients with simple renal cysts after laparoscopic deroofing.

Detailed description

Simple renal cysts (SRC) are the most frequent type of cystic renal disease. The prevalence rate of SRCs is about 10% and increases with age. Hypertension and decreased renal functions have been reported to occur more commonly among these patients with SRC and there are no clear guidelines for managing asymptomatic SRCs.Renal functional reserve (RFR) describes the capacity of the intact nephron mass to increase glomerular filtration rate(GFR) from baseline in response to stimuli (e.g., protein load).The investigators hypothesized that RFR may be improved in some patients with simple renal cysts after laparoscopic deroofing despite identical resting glomerular filtration rate (rGFR).The aim of this study is to examine whether there is improvement of RFR in patients with simple renal cysts after laparoscopic deroofing.

Interventions

PROCEDURELaparoscopic deroofing

The classic treatment of patients with simple renal cysts is deroofing, which can be performed by open surgery or laparoscopy. Laparoscopic deroofing is an effective minimally invasive approach and has gained popularity.

DRUG100 g of amino acids supplementation

intravenous supplementation with 100 g of amino acids 2 day before laparoscopic deroofing.

Sponsors

ou tongwen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Participants are assigned to two groups.One group participants are with endophytic simple renal cysts, and the other are with exophytic simple renal cysts.

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

1. Age ≥18 2. Estimated GFR \>30 mL/min/1.73m2 3. Subjects who signed informed consent forms

Exclusion criteria

1. Allergy to iothalamate, shellfish or iodine 2. Use of metformin or amiodarone 3. Inability to maintain a stable regimen of medications which affect GFR for \> one week prior to participation (e.g. non-steroidal anti-inflammatory drugs, angiotensin converting enzyme inhibitors, angiotensin receptor blockers) 4. Use of medications which directly affect elimination of creatinine (e.g. cimetidine and trimethoprim) 5. Acute exacerbation of asthma or chronic obstructive pulmonary disease within 3 months requiring hospitalization or oral steroid therapy 6. Inadequate intravenous access 7. Severe anemia (Hct \<21%) 8. Acute kidney injury (rise in creatinine to ≥1.5 times the previous baseline or by ≥ 0.3 mg/dL on most recent labs prior to enrollment) 9. History of contrast-induced nephropathy 10. Hyperthyroidism 11. Pheochromocytoma 12. Sickle cell disease 13. Urinary retention or incontinence 14. Status post organ transplant 15. Pregnancy or active breast feeding 16. Cognitive impairment with inability to give consent 17. Institutionalized status

Design outcomes

Primary

MeasureTime frameDescription
Change in renal functional reserve after laparoscopic deroofing1 month after surgery.1 month after surgery, repeated glomerular filtration rate measurements are to be performed to calculate change in renal functional reserve.

Countries

China

Contacts

Primary ContactZhenhua Shang, MD.
shangzhenhua16@126.com+8617801117318
Backup ContactHao Yan, MD.
+8683198448

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026