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

Primary Purpose

Urolithiasis

Status

Unknown status

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

RIRS with UAS

RIRS without UAS

About this trial

This is an interventional treatment trial for Urolithiasis focused on measuring kidney stone, retrograde intrarenal surgery, ureteral access sheath, 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 UrologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

UAS (+)

UAS (-)

Arm Description

RIRS with UAS: 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 UAS: 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

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT02533414

First Posted

August 23, 2015

Last Updated

March 3, 2017

Sponsor

Selcuk University

Collaborators

The Scientific and Technological Research Council of Turkey

1. Study Identification

Unique Protocol Identification Number

NCT02533414

Brief Title

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

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Unknown status

Study Start Date

August 2016 (Actual)

Primary Completion Date

June 2017 (Anticipated)

Study Completion Date

July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Selcuk University

Collaborators

The Scientific and Technological Research Council of Turkey

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urolithiasis

Keywords

kidney stone, retrograde intrarenal surgery, ureteral access sheath, 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 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

UAS (+)

Arm Type

Experimental

Arm Description

RIRS with UAS: 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

Active Comparator

Arm Description

RIRS without UAS: 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 UAS

Intervention Description

Ureteral access sheath (UAS) will be used during RIRS.

Intervention Type

Device

Intervention Name(s)

RIRS without UAS

Intervention Description

Ureteral access sheath will not be used during RIRS.

Primary Outcome Measure Information:

Title

Blood Netrin-1 level (pg/mL)

Description

Determination of any impairment in renal function when ureteral access sheath is not used during RIRS by measuring blood Netrin-1 level.

Time Frame

Within the first 48 hours after the surgery (RIRS)

Secondary Outcome Measure Information:

Title

Urine Netrin-1 level (pg/mL)

Description

Determination of any impairment in renal function when ureteral access sheath is not used during RIRS by measuring urine Netrin-1 level.

Time Frame

Within the first 24 hours after the surgery (RIRS)

Title

Blood urea level (mg/dL)

Description

Determination of any impairment in renal function when ureteral access sheath is not used during RIRS by measuring blood urea levels.

Time Frame

Within the first 7 days after surgery (RIRS)

Title

Blood creatinine level (mg/dL)

Description

Determination of any impairment in renal function when ureteral access sheath is not used during RIRS by measuring blood 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

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ozcan Kilic, MD

Phone

+905074196189

drozcankilic@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Murat Akand, MD

Phone

+905327438333

drmuratakand@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ozcan Kilic, MD

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

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ozcan Kilic, M.D.

Phone

+905074196189

drozcankilic@yahoo.com

First Name & Middle Initial & Last Name & Degree

Murat Akand, M.D.

Phone

+905327438333

drmuratakand@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

24881777

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.

Results Reference

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PubMed Identifier

24503707

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.

Results Reference

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PubMed Identifier

22642568

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.

Results Reference

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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

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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

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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

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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

25971204

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.

Results Reference

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PubMed Identifier

23701892

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.

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PubMed Identifier

24410757

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.

Results Reference

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PubMed Identifier

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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.

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Citation

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

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