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

NCT02485002 | Completed

• 1 other identifier: SU-RIRS-UAS-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

kidney; kidney stone; NGAL; ureterorenoscopy; intrarenal surgery; kidney function

Outcome Measures

Primary Outcomes (1)

• Urine NGAL level (ng/mL)

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

  Within the first 7 days after surgery (RIRS)

Secondary Outcomes (1)

• Blood urea level (mg/dL) and creatinine level (mg/dL)

  Within the first 7 days after surgery (RIRS)

Study Arms (2)

UAS (+)

ACTIVE COMPARATOR

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).

Device: RIRS with ureteral access sheath

UAS (-)

EXPERIMENTAL

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).

Device: RIRS without ureteral access sheath

Interventions

RIRS with ureteral access sheath DEVICE

Ureteral access sheath will be used during RIRS.

UAS (+)

RIRS without ureteral access sheath DEVICE

Ureteral access sheath will not be used during RIRS.

UAS (-)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University, School of Medicine, Department of Urology

Konya, 42075, Turkey (Türkiye)

Location

Related Publications (6)

• 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: 15006050 BACKGROUND

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

  PMID: 11176469 BACKGROUND

• 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: 16040093 BACKGROUND

• 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: 17338606 BACKGROUND

• 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.

  PMID: 20303517 BACKGROUND

• 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.

  PMID: 23085062 BACKGROUND

MeSH Terms

Conditions

Urolithiasis; Kidney Calculi

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nephrolithiasis; Kidney Diseases; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ozcan Kilic, M.D.

  Selcuk University, School of Medicine, Department of Urology

  PRINCIPAL INVESTIGATOR

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: June 24, 2015
• First Posted: June 30, 2015
• Study Start: June 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: November 18, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)