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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04110574
Collaborator
(none)
100
31

Study Details

Study Description

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 Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated 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
    Anticipated Study Start Date :
    Mar 30, 2020
    Anticipated Primary Completion Date :
    Sep 1, 2022
    Anticipated Study Completion Date :
    Oct 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. comparison of CT densities of urinary stones with its chemical composition [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 .

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    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 .

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    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:
    Oct 1, 2019
    Last Update Posted:
    Feb 5, 2020
    Last Verified:
    Feb 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 5, 2020