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

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

Study Overview

• Status: Unknown
• Conditions: Simple Renal Cyst
• Intervention / Treatment: Procedure: Laparoscopic deroofing; Drug: 100 g of amino acids supplementation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhenhua Shang, MD.; Phone Number: +8617801117318; Email: shangzhenhua16@126.com
• Study Contact Backup: Name: Hao Yan, MD.; Phone Number: +8683198448

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Xuanwu Hospital Capital Medical University
      • Contact: Zhenhua Shang, MD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; Other Names: Compound Amino Acids Injection(18AA-Ⅶ)
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.	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.; Other Names: Compound Amino Acids Injection(18AA-Ⅶ)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: ou tongwen
• Investigators: Study Chair: Tongwen Ou, MD., Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: August 21, 2017
• First Submitted That Met QC Criteria: August 21, 2017
• First Posted (Actual): August 23, 2017

Study Record Updates

• Last Update Posted (Actual): April 29, 2020
• Last Update Submitted That Met QC Criteria: April 27, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Renal functional reserve; Simple renal cysts; Laparoscopic deroofing
• Additional Relevant MeSH Terms: Neoplasms; Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Cysts; Kidney Diseases, Cystic
• Other Study ID Numbers: otw-20170804-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No