- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03259594
Measurement of Renal Functional Reserve Change In Patients With SRC Before and After Laparoscopic Deroofing
April 27, 2020 updated by: ou tongwen
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
-
-
Beijing
-
Beijing, Beijing, China, 100053
- Recruiting
- Xuanwu Hospital Capital Medical University
-
Contact:
- Zhenhua Shang, MD.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- Age ≥18
- Estimated GFR >30 mL/min/1.73m2
- Subjects who signed informed consent forms
Exclusion Criteria:
- Allergy to iothalamate, shellfish or iodine
- Use of metformin or amiodarone
- 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)
- Use of medications which directly affect elimination of creatinine (e.g. cimetidine and trimethoprim)
- Acute exacerbation of asthma or chronic obstructive pulmonary disease within 3 months requiring hospitalization or oral steroid therapy
- Inadequate intravenous access
- Severe anemia (Hct <21%)
- 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)
- History of contrast-induced nephropathy
- Hyperthyroidism
- Pheochromocytoma
- Sickle cell disease
- Urinary retention or incontinence
- Status post organ transplant
- Pregnancy or active breast feeding
- Cognitive impairment with inability to give consent
- Institutionalized status
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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.
|
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.
intravenous supplementation with 100 g of amino acids 2 day before laparoscopic deroofing.
Other Names:
|
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.
|
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.
intravenous supplementation with 100 g of amino acids 2 day before laparoscopic deroofing.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 month after surgery.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Tongwen Ou, MD., Xuanwu Hospital, Beijing
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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