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

March 3, 2017 updated by: Ozcan Kilic, Selcuk University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Konya, Turkey, 42075
        • Recruiting
        • Selcuk University, School of Medicine, Department of Urology
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: UAS (+)
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
Ureteral access sheath (UAS) will be used during RIRS.
Active Comparator: UAS (-)
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
Ureteral access sheath will not be used during RIRS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Netrin-1 level (pg/mL)
Time Frame: Within the first 48 hours after the surgery (RIRS)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urine Netrin-1 level (pg/mL)
Time Frame: Within the first 24 hours after the surgery (RIRS)
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)
Blood urea level (mg/dL)
Time Frame: Within the first 7 days after surgery (RIRS)
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)
Blood creatinine level (mg/dL)
Time Frame: Within the first 7 days after surgery (RIRS)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Selcuk University

Collaborators

The Scientific and Technological Research Council of Turkey

Investigators

  • Principal Investigator: Ozcan Kilic, MD, Selcuk University, School of Medicine, Department of Urology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

August 23, 2015

First Submitted That Met QC Criteria

August 24, 2015

First Posted (Estimate)

August 26, 2015

Study Record Updates

Last Update Posted (Actual)

March 6, 2017

Last Update Submitted That Met QC Criteria

March 3, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SU-RIRS-UAS-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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