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

Urolithiasis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02485002
• Other study ID #: SU-RIRS-UAS-02
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: March 2016

Study information

• Verified date: November 2019
• Source: Selcuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Urolithiasis

Intervention

Device:
• RIRS with ureteral access sheath
Ureteral access sheath will be used during RIRS.
• RIRS without ureteral access sheath
Ureteral access sheath will not be used during RIRS.

Locations

Country	Name	City	State
Turkey	Selcuk University, School of Medicine, Department of Urology	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View 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. — View 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. — View Citation

Kourambas J, Byrne RR, Preminger GM. Does a ureteral access sheath facilitate ureteroscopy? J Urol. 2001 Mar;165(3):789-93. — View 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. — View Citation

Stern JM, Yiee J, Park S. Safety and efficacy of ureteral access sheaths. J Endourol. 2007 Feb;21(2):119-23. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within the first 7 days after surgery (RIRS)
Secondary	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.	Within the first 7 days after surgery (RIRS)