Circulatory; ChangeNCT03023488
Effects of Flexible Ureteroscopy on Renal Blood Flow
A study testing flexible ureteroscopy, Doppler Ultrasound examination and laser lithotripsy in people with Circulatory; Change, run by Marmara University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Circulatory; Change
- What is being tested?
- flexible ureteroscopy, Doppler Ultrasound examination and laser lithotripsy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between ages 18-65
- Patients undergoing flexible ureteroscopy + laser lithotripsy according to EAU Guidelines on Urolithiasis
Who cannot join
- Pregnant patients
- Patients with already-diagnosed urological malignancies
- Patients ineligible for flexible ureteroscopy due to concomitant co-morbidities
About this study
Official title: Effects Of Flexible Ureteroscopy On Renal Blood Flow
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.
Read the detailed description
Aim of this study is to investigate the effects of increased intrarenal pressure during flexible ureteroscopy on renal blood flow.
Patients undergoing flexible ureteroscopy and laser lithotripsy for kidney stones according to 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.
Flexible ureteroscopy has been a key component of kidney stone management in the last 20 years. Even for stones larger than 2 cm, flexible ureteroscopy can be performed with high success and low complication rates. Ureteral access sheaths are key contributors to flexible ureteroscopy as they provide easy and repeated access to upper urinary tract and decreased intrarenal pressures due to easy flow back of the irrigation solution.
The increased pressures during flexible ureteroscopy have been an important research area in the last years. Due to irrigation solution and irrigational pumping to provide a clearer vision during flexible ureteroscopy, intrarenal pressures rise and after a certain point pyelo-sinusoidal, pyelo-venous and pyelo-lymphatic backflow starts. It has been shown that this backflow starts when pressure rises above 40 cmH2O (centimeters-water / unit of pressure measurement). Schwalb et al. demonstrated in their study that in kidneys subject to high intrarenal pressure, denudation and flattening of the caliceal urothelium, submucosal edema and congestion are observed. Due to these deleterious effects on urothelium, renal extravasation and bacterial translocation can occur and complications may arise.
Renal Doppler US, due to its non-invasive nature, has been widely used to measure localized blood flow in the kidneys, to evaluate hemodynamic parameters in acute kidney injury. Intrarenal backflow and its consequences such as submucosal edema and congestion may decrease blood flow especially around the calyces subject to high pressures and this situation may result in acute kidney injury.
- Conditions
- Circulatory; Change
- Being tested
- flexible ureteroscopy, Doppler Ultrasound examination, laser lithotripsy
- Keywords
- flexible ureteroscopy, blood flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flexible ureteroscopyProcedure or surgery
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: flexible ureteroscopy; Device: Doppler Ultrasound examination; Device: laser lithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
The size of access sheaths will be given in French measurement. E.g. 10/12 Fr
Measured: 1 hour after the operation
Technical Details - Name of Flexible Ureteroscope
Each ureteroscope has unique characteristics. So, every ureteroscope that will be used, will be recorded with its name. E.g. Storz Flex-X2, Olympus V1, Wolf Cobra
Measured: 1 hour after the operation
Duration of the Flexible Ureteroscopy Operation
the data about the duration of the operation that will be performed for each patient and the data will be recorded in minutes.
Measured: 10 minutes after the operation
Operative Characteristics - Irrigation Pressure
The pressure that is applied to the irrigation solution which is circulated through the ureteroscope that is used to expand the renal cavities during a flexible ureteroscopy operation. the data will be collected in cmH2O. This pressure value is a constant value and it doesn't change throughout the length of the procedure.
Measured: 1 hour after the operation
Operative Characteristics - Intraoperative Complications
The number of patients that has experienced any kind of intraoperative complications during the flexible ureteroscopy operation.
Measured: 1 hour after the operation
Post-Operative Characteristics - Complications
The number of patients that had a complication in the first 1 month after the operation according to the Clavien Dindo Grading system (0-5).
Clavien Dindo Grading ranges from 0 (mildest) to 5 (most severe). 0. No complications
- Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Allowed therapeutic regimens are drugs as antiemetics, antipyretics, analgesics, diuretics, electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside
- Complications requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included
- Complications requiring surgical, endoscopic or radiological intervention
- Life-threatening complications (including CNS complications) requiring IC/ICU management
- Death
Measured: The data will be recorded within 1 month after each procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startFeb 2016
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Circulatory; ChangeStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tarik Emre Sener, Urologist, Principal investigator, Marmara University, School of Medicine, Department of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023488
- Sponsor's protocol ID
- MAR.UAD.002
- Other IDs
- 09.2016.181
- Status last verified
- Jun 2018
- First submitted
- 11 Feb 2016
- Last updated
- 6 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 8501816de 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.
PubMed 24147820Sener 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.
PubMed 26381037
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Flexible Ureteroscopy On Renal Blood Flow
- ClinicalTrials.gov ID
- NCT03023488
- Acronym / sponsor ID
- MAR.UAD.002
- Conditions
- Circulatory; Change
- Keywords
- flexible ureteroscopy, blood flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 18 Jan 2017 (estimated)
- Results
- Posted 18 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aim of this study is to investigate the effects of increased intrarenal pressure during flexible ureteroscopy on renal blood flow.
Patients undergoing flexible ureteroscopy and laser lithotripsy for kidney stones according to 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.
Flexible ureteroscopy has been a key component of kidney stone management in the last 20 years. Even for stones larger than 2 cm, flexible ureteroscopy can be performed with high success and low complication rates. Ureteral access sheaths are key contributors to flexible ureteroscopy as they provide easy and repeated access to upper urinary tract and decreased intrarenal pressures due to easy flow back of the irrigation solution.
The increased pressures during flexible ureteroscopy have been an important research area in the last years. Due to irrigation solution and irrigational pumping to provide a clearer vision during flexible ureteroscopy, intrarenal pressures rise and after a certain point pyelo-sinusoidal, pyelo-venous and pyelo-lymphatic backflow starts. It has been shown that this backflow starts when pressure rises above 40 cmH2O (centimeters-water / unit of pressure measurement). Schwalb et al. demonstrated in their study that in kidneys subject to high intrarenal pressure, denudation and flattening of the caliceal urothelium, submucosal edema and congestion are observed. Due to these deleterious effects on urothelium, renal extravasation and bacterial translocation can occur and complications may arise.
Renal Doppler US, due to its non-invasive nature, has been widely used to measure localized blood flow in the kidneys, to evaluate hemodynamic parameters in acute kidney injury. Intrarenal backflow and its consequences such as submucosal edema and congestion may decrease blood flow especially around the calyces subject to high pressures and this situation may result in acute kidney injury.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flexible ureteroscopy arm | Experimental | Procedure: flexible ureteroscopy, Device: Doppler Ultrasound examination, Device: laser lithotripsythe 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients between ages 18-65
- Patients undergoing flexible ureteroscopy + laser lithotripsy according to EAU Guidelines on Urolithiasis
Key exclusion criteria (3 listed)
- Pregnant patients
- Patients with already-diagnosed urological malignancies
- Patients ineligible for flexible ureteroscopy due to concomitant co-morbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flexible ureteroscopyFlexible 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. | Procedure or surgery | Flexible ureteroscopy arm |
| Doppler Ultrasound examinationpeak 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. | Device | Flexible ureteroscopy arm |
| laser lithotripsyThe 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. | Device | Flexible ureteroscopy arm |
Primary outcome
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.
Time frame: 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
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.
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.
Time frame: 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
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.
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.
Time frame: 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
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.
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.
Time frame: 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
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.
6 secondary outcomes
Technical Details - Size of Ureteral Access Sheath
Time frame: 1 hour after the operation
Technical Details - Name of Flexible Ureteroscope
Time frame: 1 hour after the operation
Duration of the Flexible Ureteroscopy Operation
Time frame: 10 minutes after the operation
Operative Characteristics - Irrigation Pressure
Time frame: 1 hour after the operation
Operative Characteristics - Intraoperative Complications
Time frame: 1 hour after the operation
Post-Operative Characteristics - Complications
Time frame: The data will be recorded within 1 month after each procedure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8501816Schwalb 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.
- Background: PubMed 24147820de 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.
- Results publication: PubMed 26381037Sener 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarik Emre Sener, Urologist principal investigator
Marmara University, School of Medicine, Department of Urology
Questions about this trial
What is this clinical trial studying?
A study testing flexible ureteroscopy, Doppler Ultrasound examination and laser lithotripsy in people with Circulatory; Change, run by Marmara University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03023488, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2018.