- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02485002
Differences in Urine NGAL Levels in Patients Undergoing RIRS With or Without Ureteral Access Sheath
November 15, 2019 updated by: Ozcan Kilic, Selcuk University
Differences in Urine Neutrophil Gelatinase-Associated Lipocalin (NGAL) Levels in Patients Undergoing Retrograde Intrarenal Surgery (RIRS) With or Without Ureteral Access Sheath (UAS)
This study will include patients aged between 18 and 65 who will undergo retrograde infrarenal surgery (RIRS) due to renal stone(s).
A total of 60 patients (male or female) will be recruited, and will be randomized into 2 groups consisting of 30 patients in each group.
The first group of patients will undergo RIRS with a ureteral access sheath (UAS) positioned prior to surgery; and the second group will undergo RIRS without UAS.
As use of UAS decreases the pressure in the renal pelvis during RIRS, it is aimed to evaluate whether using UAS or not affects the kidney functions.
besides the routine kidney function tests, namely urea and creatinine, neutrophil gelatinase-associated lipocalin (NGAL) (a more specific and early marker of kidney function) will be used to assess the differences in the kidney functions.
Preoperative blood urea and creatinine levels and urine NGAL levels will be studied for all patients.
After the surgery, blood urea and creatinine levels will be again studied as well as urine NGAL levels at postoperative 2nd hour, 72nd hour and 1st week.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
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 Locations
-
-
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Konya, Turkey, 42075
- Selcuk University, School of Medicine, Department of Urology
-
-
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 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Being between 18-65 years old
- Having an indication of retrograde infrarenal surgery (RIRS) due to kidney stone
Exclusion Criteria:
- Patients with uncontrolled diabetes mellitus and diabetic nephropathy
- Patients with blood pressure > 140/80 mmHg despite regular use of antihypertensive agent(s)
- Patients with chronic kidney failure who need dialysis
- Patients who have had prerenal, renal or postrenal acute kidney failure 3 months or much earlier
- Patients who have had pyelonephritis 3 months or much earlier
- Patients younger than 18 years or older than 65 years
- Patients who have undergone a kidney surgery within the last 3 months and have abnormal kidney function tests
- Patients with a concomitant ureter stone who will undergo an endoscopic ureter stone treatment at the same session
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: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: UAS (+)
RIRS with ureteral access sheath: A ureteral access sheath (UAS) will be positioned into the ureter of the patient prior to the insertion of the flexible ureterorenoscope (RIRS).
|
Ureteral access sheath will be used during RIRS.
|
EXPERIMENTAL: UAS (-)
RIRS without ureteral access sheath: A ureteral access sheath (UAS) will not be positioned into the ureter of the patient prior to the insertion of the flexible ureterorenoscope (RIRS).
|
Ureteral access sheath will not be used during RIRS.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urine NGAL level (ng/mL)
Time Frame: Within the first 7 days after surgery (RIRS)
|
Determination of any impairment in renal function when ureteral access sheath is not used during RIRS by measuring urine NGAL level.
|
Within the first 7 days after surgery (RIRS)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood urea level (mg/dL) and creatinine level (mg/dL)
Time Frame: Within the first 7 days after surgery (RIRS)
|
Determination of any impairment in renal function when ureteral access sheath is not used during RIRS by measuring blood urea and creatinine levels.
|
Within the first 7 days after surgery (RIRS)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Auge BK, Pietrow PK, Lallas CD, Raj GV, Santa-Cruz RW, Preminger GM. Ureteral access sheath provides protection against elevated renal pressures during routine flexible ureteroscopic stone manipulation. J Endourol. 2004 Feb;18(1):33-6. doi: 10.1089/089277904322836631.
- Kourambas J, Byrne RR, Preminger GM. Does a ureteral access sheath facilitate ureteroscopy? J Urol. 2001 Mar;165(3):789-93.
- L'esperance JO, Ekeruo WO, Scales CD Jr, Marguet CG, Springhart WP, Maloney ME, Albala DM, Preminger GM. Effect of ureteral access sheath on stone-free rates in patients undergoing ureteroscopic management of renal calculi. Urology. 2005 Aug;66(2):252-5. doi: 10.1016/j.urology.2005.03.019.
- Stern JM, Yiee J, Park S. Safety and efficacy of ureteral access sheaths. J Endourol. 2007 Feb;21(2):119-23. doi: 10.1089/end.2007.9997.
- Ichino M, Kusaka M, Kuroyanagi Y, Mori T, Morooka M, Sasaki H, Shiroki R, Shishido S, Kurahashi H, Hoshinaga K. Urinary neutrophil-gelatinase associated lipocalin is a potential noninvasive marker for renal scarring in patients with vesicoureteral reflux. J Urol. 2010 May;183(5):2001-7. doi: 10.1016/j.juro.2010.01.031. Epub 2010 Mar 19.
- Abassi Z, Shalabi A, Sohotnik R, Nativ O, Awad H, Bishara B, Frajewicki V, Sukhotnik I, Abbasi A, Nativ O. Urinary NGAL and KIM-1: biomarkers for assessment of acute ischemic kidney injury following nephron sparing surgery. J Urol. 2013 Apr;189(4):1559-66. doi: 10.1016/j.juro.2012.10.029. Epub 2012 Oct 22.
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
June 1, 2015
Primary Completion (ACTUAL)
March 1, 2016
Study Completion (ACTUAL)
March 1, 2016
Study Registration Dates
First Submitted
June 24, 2015
First Submitted That Met QC Criteria
June 25, 2015
First Posted (ESTIMATE)
June 30, 2015
Study Record Updates
Last Update Posted (ACTUAL)
November 18, 2019
Last Update Submitted That Met QC Criteria
November 15, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SU-RIRS-UAS-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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