Effect of Use of Ureteral Access Sheath on Levels of Netrin-1 in Patients Undergoing RIRS

Urolithiasis Clinical Trial

Official title:

Effect of Use of Ureteral Access Sheath on Blood and Urine Levels of Netrin-1 in Patients Undergoing Retrograde Intrarenal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02533414
• Other study ID #: SU-RIRS-UAS-04
• Status: Recruiting
• Phase: N/A
• First received: August 23, 2015
• Last updated: March 3, 2017
• Start date: August 2016
• Est. completion date: July 2017

Study information

• Verified date: March 2017
• Source: Selcuk University
• Contact: Ozcan Kilic, MD
• Phone: +905074196189
• Email: drozcankilic[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• 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 UAS
Ureteral access sheath (UAS) will be used during RIRS.
• RIRS without UAS
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 (2)

Lead Sponsor	Collaborator
Selcuk University	The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

References & Publications (12)

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. Review. — 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

Barallobre MJ, Pascual M, Del Río 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. Review. — View Citation

Cepeda M, Amón JH, Mainez JA, Rodríguez V, Alonso D, Martínez-Sagarra JM. Flexible ureteroscopy for renal stones. Actas Urol Esp. 2014 Nov;38(9):571-5. doi: 10.1016/j.acuro.2014.03.014. English, Spanish. — View 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. — 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

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. — View 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. — View 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. Review. — 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

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Netrin-1 level (pg/mL)	Determination of any impairment in renal function when ureteral access sheath is not used during RIRS by measuring blood Netrin-1 level.	Within the first 48 hours after the surgery (RIRS)
Secondary	Urine Netrin-1 level (pg/mL)	Determination of any impairment in renal function when ureteral access sheath is not used during RIRS by measuring urine Netrin-1 level.	Within the first 24 hours after the surgery (RIRS)
Secondary	Blood urea level (mg/dL)	Determination of any impairment in renal function when ureteral access sheath is not used during RIRS by measuring blood urea levels.	Within the first 7 days after surgery (RIRS)
Secondary	Blood creatinine level (mg/dL)	Determination of any impairment in renal function when ureteral access sheath is not used during RIRS by measuring blood creatinine levels.	Within the first 7 days after surgery (RIRS)