NCT03023488

Brief Summary

Aim of this study is to investigate the effects of increased intrarenal pressure during flexible ureteroscopy on renal blood flow. Patients undergoing flexible ureteroscopy (F-URS) and laser lithotripsy for kidney stones according to European Association of Urology (EAU) guidelines on Urolithiasis will be included in the study after having signed an informed consent form. The pre- and post-operative evaluation and management will be performed according to EAU Guidelines on Urolithiasis. Additionally, as a non-invasive test, bilateral renal power Doppler US will be performed to patients pre- and post-operatively. The pre-operative Doppler US will be performed 2 days prior to surgery and the post-operative Doppler US will be performed in the first 24 hours following surgery. The changes on blood flow in renal artery and arcuate artery will be recorded.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Status
completed

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

Study Start

First participant enrolled

February 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
4 months until next milestone

Results Posted

Study results publicly available

May 18, 2017

Completed
Last Updated

July 6, 2018

Status Verified

June 1, 2018

Enrollment Period

8 months

First QC Date

February 11, 2016

Results QC Date

January 18, 2017

Last Update Submit

June 6, 2018

Conditions

Circulatory; Change

Keywords

flexible ureteroscopyblood flow

Outcome Measures

Primary Outcomes (4)

  • Peak Systolic Velocities (PSV) Measurement by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters.

    Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV. PSV is the maximum velocity in the renal and arcuate arteries in the systolic phase of each heart pulse.

    The doppler examination will be performed 2 days before surgery and the change will be assessed within 1 day of the operation. So, the initial evaluation will be performed and change of values will be assessed 72 hours after the initial evaluation

  • End Diastolic Velocities (EDV) Measurement by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters.

    Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV. EDV is the velocity in the renal and arcuate arteries at the end of the diastolic phase of each heart pulse.

    The doppler examination will be performed 2 days before surgery and the change will be assessed within 1 day of the operation. So, the initial evaluation will be performed and change of values will be assessed 72 hours after the initial evaluation

  • Resistive Index (RI) Calculation by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters.

    Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV. Resistive index is calculated as the difference between PSV and EDV, divided by PSV \[(PSV - EDV) / (PSV)\]. An increased resistive index can be considered as a marker of intrarenal arterial stiffness and is associated with worsening of renal function and tubulointersitial damage.

    The doppler examination will be performed 2 days before surgery and the change will be assessed within 1 day of the operation. So, the initial evaluation will be performed and change of values will be assessed 72 hours after the initial evaluation

  • Pulsatility Index (PI) Calculation by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters.

    Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV. Pulsatility index is calculated as the difference between PSV and EDV, divided by the mean velocity \[(PSV - EDV) / ((PSV + EDV) / 2)\]. Pulsatility index is used to discriminate between renal and pre-renal causes of acute kidney injury which can alter the therapeutic options in the clinical setting.

    The doppler examination will be performed 2 days before surgery and the change will be assessed within 1 day of the operation. So, the initial evaluation will be performed and change of values will be assessed 72 hours after the initial evaluation

Secondary Outcomes (6)

  • Technical Details - Size of Ureteral Access Sheath

    1 hour after the operation

  • Technical Details - Name of Flexible Ureteroscope

    1 hour after the operation

  • Duration of the Flexible Ureteroscopy Operation

    10 minutes after the operation

  • Operative Characteristics - Irrigation Pressure

    1 hour after the operation

  • Operative Characteristics - Intraoperative Complications

    1 hour after the operation

  • +1 more secondary outcomes

Study Arms (1)

Flexible ureteroscopy arm

EXPERIMENTAL

the findings of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines Doppler Ultrasound examination has been performed in the pre-operative and post-operative periods

Procedure: flexible ureteroscopyDevice: Doppler Ultrasound examinationDevice: laser lithotripsy

Interventions

flexible ureteroscopyPROCEDURE

Flexible ureteroscopy is an endourological procedure performed for kidney stones. The flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During the operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and also to provide clear vision.

Flexible ureteroscopy arm
Doppler Ultrasound examinationDEVICE

peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.

Flexible ureteroscopy arm
laser lithotripsyDEVICE

The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and transmitted to the stones via the laser fiber.

Flexible ureteroscopy arm

Eligibility Criteria

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

You may qualify if:

  • Patients between ages 18-65
  • Patients undergoing flexible ureteroscopy + laser lithotripsy according to EAU Guidelines on Urolithiasis

You may not qualify if:

  • Pregnant patients
  • Patients with already-diagnosed urological malignancies
  • Patients ineligible for flexible ureteroscopy due to concomitant co-morbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Schwalb DM, Eshghi M, Davidian M, Franco I. Morphological and physiological changes in the urinary tract associated with ureteral dilation and ureteropyeloscopy: an experimental study. J Urol. 1993 Jun;149(6):1576-85. doi: 10.1016/s0022-5347(17)36456-x.

    PMID: 8501816BACKGROUND

  • de la Rosette J, Denstedt J, Geavlete P, Keeley F, Matsuda T, Pearle M, Preminger G, Traxer O; CROES URS Study Group. The clinical research office of the endourological society ureteroscopy global study: indications, complications, and outcomes in 11,885 patients. J Endourol. 2014 Feb;28(2):131-9. doi: 10.1089/end.2013.0436. Epub 2013 Dec 17.

    PMID: 24147820BACKGROUND

  • Sener TE, Cloutier J, Villa L, Marson F, Buttice S, Doizi S, Traxer O. Can We Provide Low Intrarenal Pressures with Good Irrigation Flow by Decreasing the Size of Ureteral Access Sheaths? J Endourol. 2016 Jan;30(1):49-55. doi: 10.1089/end.2015.0387. Epub 2015 Sep 18.

    PMID: 26381037RESULT

MeSH Terms

Interventions

Lithotripsy, Laser

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsLithotripsyAblation TechniquesSurgical Procedures, OperativeUltrasonic Surgical Procedures

Results Point of Contact

Title
Dr. Tarik Emre Sener
Organization
Marmara University, School of Medicine, Department of Urology
dr.emresener@gmail.com
+905337620712

Study Officials

  • Tarik Emre Sener, Urologist

    Marmara University, School of Medicine, Department of Urology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2016

First Posted

January 18, 2017

Study Start

February 1, 2016

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

July 6, 2018

Results First Posted

May 18, 2017

Record last verified: 2018-06