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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fabio Cesar Miranda Torricelli, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01589484
First received: April 29, 2012
Last updated: December 17, 2014
Last verified: December 2014
  Purpose

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 Intervention
Urolithiasis
Urinary Lithiasis
Kidney Calculi
Device: SWL - Compact Delta Dornier Med Tech

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Stone Clearance [ Time Frame: 12 weeks after SWL ] [ Designated as safety issue: No ]
    After 12 weeks, all patients will be submitted to a new NCCT scan to evaluate stone fragmentation and stone clearance.


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


Enrollment: 104
Study Start Date: April 2012
Study Completion Date: December 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

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
Study First Received: April 29, 2012
Results First Received: December 5, 2014
Last Updated: December 17, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
Tomography
Urinary Lithiasis
Kidney Calculi

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

ClinicalTrials.gov processed this record on May 21, 2015