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How Long Must the MRI Follow-up Last to Safely Identify Middle Ear Residual Cholesteatoma

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT04489550
Collaborator
(none)
17
Enrollment
1
Location
83.9
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Previous studies demonstrated the high diagnostic value of non-echoplanar diffusion weighted magnetic resonance imaging (non-EP DWI) for residual cholesteatoma. However, limited data are available regarding a suitable length of imaging follow-up. The present study aimed to determine the optimal duration of non-EP DWI follow-up for residual cholesteatoma

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    A retrospective, monocentric study was performed between 2013 and 2019 and included all patients regularly followed-up after canal wall-up tympanoplasty with at least two non-EP DWI performed on the same 1.5T MRI scanner. MR images were reviewed independently by two radiologists. Sensitivity and specificity values were calculated as a function of time after the surgery. Receiver operating characteristics (ROC) curves were analyzed to determine the optimal follow-up duration.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    17 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Optimal Duration of Magnetic Resonance Imaging (MRI) Follow-up to Safely Identify Middle Ear Residual Cholesteatoma
    Actual Study Start Date :
    Jan 1, 2013
    Actual Primary Completion Date :
    Dec 1, 2019
    Actual Study Completion Date :
    Dec 31, 2019

    Outcome Measures

    Primary Outcome Measures

    1. MRI sensitivity and specificity values as a function of the duration of the follow-up [1 day]

      MRI sensitivity and specificity values as a function of the duration of the follow-up. Since no official recommendations are available in the literature, the decision regarding the number of MRIs and the time lapse between any two was left to the discretion of the surgeon

    Secondary Outcome Measures

    1. Receiver operating characteristics (ROC) curves [1 day]

      the receiver operating characteristics (ROC) curves

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:
    • patients regularly followed-up for middle ear cholesteatoma, who underwent two or more non-EP DWI performed on the same 1.5 Tesla MRI scanner
    Exclusion criteria:
    • congenital cholesteatomas, tympanoplasty with canal wall-down technique, or suspicion of residual cholesteatoma on the first MRI follow-up

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uhmontpellier Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

    • Study Director: Frederic Venail, MD, PhD, University Hospital, Montpellier

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT04489550
    Other Study ID Numbers:
    • RECHMPL20_0224
    First Posted:
    Jul 28, 2020
    Last Update Posted:
    Jul 29, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier
    residual cholesteatoma
    imaging follow-up
    canal wall-up tympanoplasty
    non-EP DWI
    Additional relevant MeSH terms:
    Cholesteatoma, Middle Ear
    Cholesteatoma

    Study Results

    No Results Posted as of Jul 29, 2020