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Computed Tomography Evaluation of Urinary Stones Densities Compared to in Vitro Analysis of Its Chemical Composition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04110574
Recruitment Status : Not yet recruiting
First Posted : October 1, 2019
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Somia Usama Mohamed Rabea, Assiut University

Brief Summary:
The ability to predict stone composition, which influences patient treatment, depends on the accurate measurement of CT attenuation of stones. We will study the effects of stone composition, stone size, and scan collimation width on the measurement of attenuation in vitro.

Condition or disease
Urinary Calculi

Detailed Description:
Recently, the use of noncontrast spiral computerized tomography (NCCT) has gained widespread acceptance in the evaluation of urinary stone patients. It has long been used clinically to evaluate the causes of radiolucent filling defects using Hounsfield units (HU) to distinguish calculi from tumor or blood clots, and to identify nonurologic causes of flank pain (Smith R etal ). Urinary stones have a significantly higher CT attenuation than the surrounding soft tissues and are virtually always visible on NCCT. Knowing the composition of a urinary calculus is frequently a key factor in determining its most appropriate management. Should the urine be alkalinized? Will the stone be amenable to extracorporeal shock wave lithotripsy (ESWL), or should ureteroscopy or percutaneous lithotripsy be attempted? Different techniques have been used to assist in determining the correct chemical composition of calculi. Urine pH, urinary crystals, prior stone history and the presence of urea-splitting organisms (Ramakumar S,etal). Several in vitro studies have suggested that NCCT can demonstrate measured differences in radiodensity among different urinary stones (Mitchenson HD etal,).With these clinical problems in mind, we sought to determine whether the composition of urinary calculi could be predicted by their CT characteristics in an attempt to find out the best technique for distinguishing the various stones compositions, provided that it is clinically practical and would not require repeated imaging of the patients.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Computed Tomography Evaluation of Urinary Stones Densities Compared to in Vitro Analysis of Its Chemical Composition
Estimated Study Start Date : March 30, 2020
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : October 30, 2022



Primary Outcome Measures :
  1. comparison of CT densities of urinary stones with its chemical composition [ Time Frame: Baseline ]
    determination whether the composition of urinary calculi could be predicted by their CT characteristics in an attempt to find out the best technique for distinguishing the various stones compositions .



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with suspected or known urinary stone disease and were included in the study who attend to out patient clinic of Urology department of Assiut university hospital or admitted in the ward.
Criteria

Inclusion Criteria:

  • Any Age will be included .
  • Patient with suspected or known urinary stone disease.
  • Eligible for doing NCCT.
  • Giving written consent to participate

Exclusion Criteria:

  • Patient with classical NCCT contraindication like morbid obesity and pregnancy .
  • Patients with urinary stones will be treated by ESWL
  • Refusal participation .

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): NCT04110574


Contacts
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Contact: Somia Usama, Master 01060101215 somiaumrm@gmail.com

Sponsors and Collaborators
Assiut University
Additional Information:
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Responsible Party: Somia Usama Mohamed Rabea, Resident doctor, Assiut University
ClinicalTrials.gov Identifier: NCT04110574    
Other Study ID Numbers: CT of urinary stones densities
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Calculi
Urolithiasis
Calculi
Pathological Conditions, Anatomical
Urologic Diseases