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

Overview

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

Full Title of Study: “Measurement of Renal Functional Reserve Change In Patients With Simple Renal Cysts Before and After Laparoscopic Deroofing”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2020

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

  • Procedure: Laparoscopic 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.
  • Drug: 100 g of amino acids supplementation
    • intravenous supplementation with 100 g of amino acids 2 day before laparoscopic deroofing.

Arms, Groups and Cohorts

  • Experimental: endophytic group
    • participants are with endophytic renal cyst and undergo laparoscopic deroofing.2 day before laparoscopic deroofing, they were given intravenous 100 g of amino acids supplementation.
  • Sham Comparator: exophytic group
    • participants are with exophytic renal cyst and undergo laparoscopic deroofing.2 day before laparoscopic deroofing, they were given intravenous 100 g of amino acids supplementation.

Clinical Trial Outcome Measures

Primary Measures

  • Change in renal functional reserve after laparoscopic deroofing
    • Time Frame: 1 month after surgery.
    • 1 month after surgery, repeated glomerular filtration rate measurements are to be performed to calculate change in renal functional reserve.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ou tongwen
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: ou tongwen, Head of Urology – Xuanwu Hospital, Beijing
  • Overall Official(s)
    • Tongwen Ou, MD., Study Chair, Xuanwu Hospital, Beijing
  • Overall Contact(s)
    • Zhenhua Shang, MD., +8617801117318, shangzhenhua16@126.com

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