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Differences in Urine NGAL Levels in Patients Undergoing RIRS With or Without Ureteral Access Sheath

Primary Purpose

Urolithiasis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
RIRS with ureteral access sheath
RIRS without ureteral access sheath
Sponsored by
Selcuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urolithiasis focused on measuring kidney, kidney stone, NGAL, ureterorenoscopy, intrarenal surgery, kidney function

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Selcuk University, School of Medicine, Department of Urology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

UAS (+)

UAS (-)

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Urine NGAL level (ng/mL)
Determination of any impairment in renal function when ureteral access sheath is not used during RIRS by measuring urine NGAL level.

Secondary Outcome Measures

Blood urea level (mg/dL) and creatinine level (mg/dL)
Determination of any impairment in renal function when ureteral access sheath is not used during RIRS by measuring blood urea and creatinine levels.

Full Information

First Posted
June 24, 2015
Last Updated
November 15, 2019
Sponsor
Selcuk University
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1. Study Identification

Unique Protocol Identification Number
NCT02485002
Brief Title
Differences in Urine NGAL Levels in Patients Undergoing RIRS With or Without Ureteral Access Sheath
Official Title
Differences in Urine Neutrophil Gelatinase-Associated Lipocalin (NGAL) Levels in Patients Undergoing Retrograde Intrarenal Surgery (RIRS) With or Without Ureteral Access Sheath (UAS)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urolithiasis
Keywords
kidney, kidney stone, NGAL, ureterorenoscopy, intrarenal surgery, kidney function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UAS (+)
Arm Type
Active Comparator
Arm Description
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).
Arm Title
UAS (-)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
RIRS with ureteral access sheath
Intervention Description
Ureteral access sheath will be used during RIRS.
Intervention Type
Device
Intervention Name(s)
RIRS without ureteral access sheath
Intervention Description
Ureteral access sheath will not be used during RIRS.
Primary Outcome Measure Information:
Title
Urine NGAL level (ng/mL)
Description
Determination of any impairment in renal function when ureteral access sheath is not used during RIRS by measuring urine NGAL level.
Time Frame
Within the first 7 days after surgery (RIRS)
Secondary Outcome Measure Information:
Title
Blood urea level (mg/dL) and creatinine level (mg/dL)
Description
Determination of any impairment in renal function when ureteral access sheath is not used during RIRS by measuring blood urea and creatinine levels.
Time Frame
Within the first 7 days after surgery (RIRS)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ozcan Kilic, M.D.
Organizational Affiliation
Selcuk University, School of Medicine, Department of Urology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Selcuk University, School of Medicine, Department of Urology
City
Konya
ZIP/Postal Code
42075
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15006050
Citation
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.
Results Reference
background
PubMed Identifier
11176469
Citation
Kourambas J, Byrne RR, Preminger GM. Does a ureteral access sheath facilitate ureteroscopy? J Urol. 2001 Mar;165(3):789-93.
Results Reference
background
PubMed Identifier
16040093
Citation
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.
Results Reference
background
PubMed Identifier
17338606
Citation
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.
Results Reference
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PubMed Identifier
20303517
Citation
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.
Results Reference
background
PubMed Identifier
23085062
Citation
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.
Results Reference
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Differences in Urine NGAL Levels in Patients Undergoing RIRS With or Without Ureteral Access Sheath

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