NCT02533414

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2015

Completed
11 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

March 6, 2017

Status Verified

March 1, 2017

Enrollment Period

10 months

First QC Date

August 23, 2015

Last Update Submit

March 3, 2017

Conditions

Urolithiasis

Keywords

kidney stoneretrograde intrarenal surgeryureteral access sheathkidney function

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Urine Netrin-1 level (pg/mL)

    Within the first 24 hours after the surgery (RIRS)

  • Blood urea level (mg/dL)

    Within the first 7 days after surgery (RIRS)

  • Blood creatinine level (mg/dL)

    Within the first 7 days after surgery (RIRS)

Study Arms (2)

UAS (+)

EXPERIMENTAL

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).

Device: RIRS with UAS

UAS (-)

ACTIVE COMPARATOR

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).

Device: RIRS without UAS

Interventions

RIRS with UASDEVICE

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

UAS (+)
RIRS without UASDEVICE

Ureteral access sheath will not be used during RIRS.

UAS (-)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being between 18-65 years old
  • Having an indication of retrograde infrarenal surgery (RIRS) due to kidney stone

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University, School of Medicine, Department of Urology

Konya, 42075, Turkey (Türkiye)

RECRUITING

Related Publications (12)

  • 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.

    PMID: 24881777BACKGROUND

  • 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.

    PMID: 24503707BACKGROUND

  • 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.

    PMID: 22642568BACKGROUND

  • 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.

    PMID: 15006050BACKGROUND

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

    PMID: 11176469BACKGROUND

  • 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.

    PMID: 16040093BACKGROUND

  • 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.

    PMID: 17338606BACKGROUND

  • 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.

    PMID: 25971204BACKGROUND

  • 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.

    PMID: 23701892BACKGROUND

  • 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.

    PMID: 24410757BACKGROUND

  • 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.

    PMID: 15960985BACKGROUND

  • 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.

    PMID: 20007677BACKGROUND

MeSH Terms

Conditions

UrolithiasisKidney Calculi

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesNephrolithiasisKidney DiseasesUrinary CalculiCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Ozcan Kilic, MD

    Selcuk University, School of Medicine, Department of Urology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ozcan Kilic, MD

CONTACT

+905074196189drozcankilic@yahoo.com

Murat Akand, MD

CONTACT

+905327438333drmuratakand@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, M.D.

Study Record Dates

First Submitted

August 23, 2015

First Posted

August 26, 2015

Study Start

August 1, 2016

Primary Completion

June 1, 2017

Study Completion

July 1, 2017

Last Updated

March 6, 2017

Record last verified: 2017-03

Locations

TU(1)