Clinical trial NCT02533414: Effect of Use of Ureteral Access Sheath on Levels of Netrin-1 in Patients Undergoing RIRS
Official title: Effect of Use of Ureteral Access Sheath on Blood and Urine Levels of Netrin-1 in Patients Undergoing Retrograde Intrarenal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urolithiasis
Keywords: kidney stone
retrograde intrarenal surgery
ureteral access sheath
kidney function
Lead sponsor: Selcuk University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2015-08-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, it is aimed to evaluate whether use of a ureteral access sheath (UAS) during retrograde intrarenal surgery (RIRS) due to kidney stone has any effect on protecting the kidney functions by measuring blood and urine and Netrin-1 levels.

Detailed description: This study will include patients aged between 18 and 65 who will undergo retrograde intrarenal 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, and Netrin-1 (more specific and early marker of kidney function) will be used to assess the differences in the kidney functions. Preoperative blood urea, creatinine and Netrin-1 levels and urine Netrin-1 levels will be studied for all patients. After the surgery, blood urea and creatinine levels will be again studied as well as blood Netrin-1 levels at postoperative 48th hour; and urine Netrin-1 levels at postoperative 24th hour.

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

Primary outcomes:
measure: Blood Netrin-1 level (pg/mL)
timeFrame: Within the first 48 hours after the surgery (RIRS)
Secondary outcomes:
measure: Urine Netrin-1 level (pg/mL)
timeFrame: Within the first 24 hours after the surgery (RIRS)
measure: Blood urea level (mg/dL)
timeFrame: Within the first 7 days after surgery (RIRS)
measure: Blood creatinine level (mg/dL)
timeFrame: Within the first 7 days after surgery (RIRS)
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University, School of Medicine, Department of Urology
Study officials:
affiliation: Selcuk University, School of Medicine, Department of Urology
name: Ozcan Kilic, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cepeda M, Amon JH, Mainez JA, Rodriguez V, Alonso D, Martinez-Sagarra JM. Flexible ureteroscopy for renal stones. Actas Urol Esp. 2014 Nov;38(9):571-5. doi: 10.1016/j.acuro.2014.03.014. Epub 2014 Jun 2. English, Spanish.
citation: Oguz U, Resorlu B, Ozyuvali E, Bozkurt OF, Senocak C, Unsal A. Categorizing intraoperative complications of retrograde intrarenal surgery. Urol Int. 2014;92(2):164-8. doi: 10.1159/000354623. Epub 2014 Feb 6.
citation: Aboumarzouk OM, Monga M, Kata SG, Traxer O, Somani BK. Flexible ureteroscopy and laser lithotripsy for stones >2 cm: a systematic review and meta-analysis. J Endourol. 2012 Oct;26(10):1257-63. doi: 10.1089/end.2012.0217. Epub 2012 Jul 30.
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.
citation: Kourambas J, Byrne RR, Preminger GM. Does a ureteral access sheath facilitate ureteroscopy? J Urol. 2001 Mar;165(3):789-93.
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.
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.
citation: Traxer O, Wendt-Nordahl G, Sodha H, Rassweiler J, Meretyk S, Tefekli A, Coz F, de la Rosette JJ. Differences in renal stone treatment and outcomes for patients treated either with or without the support of a ureteral access sheath: The Clinical Research Office of the Endourological Society Ureteroscopy Global Study. World J Urol. 2015 Dec;33(12):2137-44. doi: 10.1007/s00345-015-1582-8. Epub 2015 May 14.
citation: Shlipak MG, Mattes MD, Peralta CA. Update on cystatin C: incorporation into clinical practice. Am J Kidney Dis. 2013 Sep;62(3):595-603. doi: 10.1053/j.ajkd.2013.03.027. Epub 2013 May 20.
citation: Delanaye P, Cavalier E, Morel J, Mehdi M, Maillard N, Claisse G, Lambermont B, Dubois BE, Damas P, Krzesinski JM, Lautrette A, Mariat C. Detection of decreased glomerular filtration rate in intensive care units: serum cystatin C versus serum creatinine. BMC Nephrol. 2014 Jan 13;15:9. doi: 10.1186/1471-2369-15-9.
citation: Barallobre MJ, Pascual M, Del Rio JA, Soriano E. The Netrin family of guidance factors: emphasis on Netrin-1 signalling. Brain Res Brain Res Rev. 2005 Jul;49(1):22-47. doi: 10.1016/j.brainresrev.2004.11.003. Epub 2005 Jan 15.
citation: Ramesh G, Krawczeski CD, Woo JG, Wang Y, Devarajan P. Urinary netrin-1 is an early predictive biomarker of acute kidney injury after cardiac surgery. Clin J Am Soc Nephrol. 2010 Mar;5(3):395-401. doi: 10.2215/CJN.05140709. Epub 2009 Dec 10.