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

NCT ID: NCT02485002

Last Updated: 2019-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-03-31

Brief 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.

Conditions

Urolithiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

UAS (+)

RIRS with ureteral access sheath: A ureteral access sheath (UAS) will be positioned into the ureter of the patient prior to the insertion of the flexible ureterorenoscope (RIRS).

Group Type: ACTIVE_COMPARATOR

RIRS with ureteral access sheath

Intervention Type: DEVICE

Ureteral access sheath will be used during RIRS.

UAS (-)

RIRS without ureteral access sheath: A ureteral access sheath (UAS) will not be positioned into the ureter of the patient prior to the insertion of the flexible ureterorenoscope (RIRS).

Group Type: EXPERIMENTAL

RIRS without ureteral access sheath

Intervention Type: DEVICE

Ureteral access sheath will not be used during RIRS.

Interventions

RIRS with ureteral access sheath

Ureteral access sheath will be used during RIRS.

Intervention Type: DEVICE

RIRS without ureteral access sheath

Ureteral access sheath will not be used during RIRS.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Selcuk University

OTHER

Sponsor Role: lead

Responsible Party

Ozcan Kilic

Associate Professor, M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ozcan Kilic, M.D.

Role: PRINCIPAL_INVESTIGATOR

Selcuk University, School of Medicine, Department of Urology

Locations

Selcuk University, School of Medicine, Department of Urology

Konya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 15006050 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 11176469 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16040093 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17338606 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20303517 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23085062 (View on PubMed)

Other Identifiers

SU-RIRS-UAS-02

Identifier Type: -

Identifier Source: org_study_id