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Impact of Renal Anatomy on Shock Wave Lithotripsy Outcomes for Lower Pole Kidney Stones

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ClinicalTrials.gov Identifier: NCT01589484
Recruitment Status : Completed
First Posted : May 2, 2012
Results First Posted : December 12, 2014
Last Update Posted : January 7, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Kidney stone disease affects almost 10% of overall population, often requiring a surgical intervention. Currently, shock wave lithotripsy is considered a first-line treatment option for patients suffering from symptomatic kidney stones smaller than 2.0 cm, providing reasonable stone-free rate. Actually, the outcomes from SWL vary largely due to several factors including stone burden, stone density, stone-skin distance (SSD), and patient's body habitus. Furthermore, the imaging exam modality (i.e. ultrasound versus computed tomography scan) performed to assess the presence of residual fragments also impacts on SWL outcome analysis.

We aim to perform a well-controlled prospective evaluation of all variables that may impact on fragmentation and clearance of lower pole calculi after SWL. These variables are assessed exclusively by a noncontrast computed tomography scan (NCCT), eliminating the necessity of an intravenous urography to study renal collecting system anatomy; an imaging exam that is not routinely performed anymore for kidney stone patients.


Condition or disease Intervention/treatment
Urolithiasis Urinary Lithiasis Kidney Calculi Device: SWL - Compact Delta Dornier Med Tech

Detailed Description:

Variables in study:

  • Age, gender, body mass index (BMI), and waist abdominal circumference
  • Noncontrast computed tomography scan (NCCT): stone density (average of 3 measurements), stone size, stone area, skin to stone distance (average of 3 measurements: zero, 45o and 90o), and collecting system anatomy: infundibular length, width, and height, and infundibulopelvic angle

Study design:

All patients will be submitted to a noncontrast computed tomography scan before to SWL. A radiologist with expertise in urolithiasis will evaluate all exams.

Patients will be submitted to SWL under the following conditions: outpatient, general anesthesia, 3000 impulses, rate of 90/min, discharged from hospital in the same day with alpha-blocker (doxazosin) during 30 days.

Patients will be followed up as follow:

  • One week after SWL: medical visit To evaluate complications such as pain, dysuria, hematuria, steinstrasse, visit to the emergency department.
  • 12 weeks after SWL: new NCCT scan To evaluate kidney stones fragmentation and clearance.

Univariate (Student's T test) and multivariate analysis (multiple logistic regression) will be done to assess the impact of patient's corporal habitus (BMI and abdominal waist circumference), stone characteristics (size, area, density and SSD), and renal collecting system anatomy (infundibular length, width and height, and infundibulopelvic angle) on SWL outcomes (fragmentation and stone-free rates).


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Renal Anatomy on Shock Wave Lithotripsy Outcomes for Lower Pole Kidney Stones: Results From a Prospective Multifactorial Analysis
Study Start Date : April 2012
Primary Completion Date : August 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Shockwave lithotripsy (SWL)
All patients will be submitted to a noncontrast computed tomography before to shockwave lithotripsy (SWL). Patients will be submitted to SWL under the following conditions: outpatient, general anesthesia, 3000 impulses, rate of 90/min, discharged from hospital in the same day with alpha-blocker (doxazosin) during 30 days.
Device: SWL - Compact Delta Dornier Med Tech
All patients will be submitted to a noncontrast computed tomography before to SWL. Patients will be submitted to SWL under the following conditions: outpatient, general anesthesia, 3000 impulses, rate of 90/min, discharged from hospital in the same day with alpha-blocker (doxazosin) during 30 days.
Other Names:
  • Extracorporeal shockwave lithotripsy
  • Compact Delta Dornier Med Tech
  • Nephrolithotripsy


Outcome Measures

Primary Outcome Measures :
  1. Stone Clearance [ Time Frame: 12 weeks after SWL ]
    After 12 weeks, all patients will be submitted to a new NCCT scan to evaluate stone fragmentation and stone clearance.


Secondary Outcome Measures :
  1. SWL Complications [ Time Frame: 12 weeks after SWL ]
    Secondary endpoint will be SWL complications (i.e. pain, hematuria, urinary tract infection, Steinstrasse)


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

> 17 year-old. Symptomatic single stone of 5 to 20mm located in the lower pole of the kidney. Informed consent signed.

Exclusion Criteria:

Patients with congenital kidney abnormalities (i.e. horseshoes kidney, pelvic kidney, ectopic kidney), patients with ureteral stent (i.e. Double J stent) in the ipsilateral kidney of the stone in study, patients with chronic kidney disease (glomerular filtration rate <60 mL/minute/1.73m2 measured by the equation "Modification of Diet in Renal Disease"), and patients with absolute contraindication to SWL (i.e. coagulopathy, pregnancy, urinary tract infection, or abdominal aneurysm >4.0cm).

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01589484


Locations
Brazil
University of Sao Paulo
Sao Paulo, SP, Brazil
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Fabio CM Torricelli, MD University of Sao Paulo
More Information

Responsible Party: Fabio Cesar Miranda Torricelli, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01589484     History of Changes
Other Study ID Numbers: 00795812.8.0000.0068
First Posted: May 2, 2012    Key Record Dates
Results First Posted: December 12, 2014
Last Update Posted: January 7, 2015
Last Verified: December 2014

Keywords provided by Fabio Cesar Miranda Torricelli, University of Sao Paulo:
Tomography
Urinary Lithiasis
Kidney Calculi

Additional relevant MeSH terms:
Kidney Calculi
Nephrolithiasis
Calculi
Urolithiasis
Lithiasis
Kidney Diseases
Urologic Diseases
Urinary Calculi
Pathological Conditions, Anatomical
Pathologic Processes