UnknownNot Applicable

Diffusion Weighted MRI Accuracy in Cholesteatoma Localization

France30 participantsStarted 2018-07-01

Plain-language summary

Magnetic resonance imaging of the middle ear has an increasing place in the therapeutic strategy in otology and especially for cholesteatoma. It is currently performed for complicated cholesteatomas and as part of the follow-up of operated patients to detect a recurrence or a cholesteatoma residue (alternative of choice to "second look" surgery). Some people take CT and MRI fusion to improve the localization of cholesteatoma. Many studies have investigated the diagnostic capabilities of MRI but very few have demonstrate their reliability in location diagnosis. The aim of the study was to propose a topographic reading method of the MRI of the middle ear and to evaluate the performances in the localization of the cholesteatoma in order to adapt the surgical management

Who can participate

Age range

18 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

inclusion criteria * Age: from 1 month and up * Sex: man / woman * Patient who had a tympanoplasty in closed technique, for the first surgical time of a cholesteatoma or for residual or recurrent cholesteatoma, performed by the same radiologist (Pr Anne Charpiot) with the following characteristics: * Code of the Common Classification of Medical Acts (CCAM) * Exeresis of cholesteatoma with tympanoplasty in closed technique and ossiculoplasty (CBFA002) * Exeresis of cholesteatoma with tympanoplasty in closed technique (CBFA006) * Exeresis of cholesteatoma confined to the tympanic cavity without antro-attic exploration (CBFA005) * Tympanoplasty in closed technique with posterior tympanotomy (CBMD001) * Secondary tympanoplasty in closed technique (CBMD002) * Diagnostic code of the International Classification of Diseases (ICD10) * Cholesteatoma of the middle ear (H71) * Diagnosis of macroscopic and / or pathological cholesteatoma. * Preoperative diagnosis of cholesteatoma on MRI of the middle ear performed in less than 6 months by the same radiologist (Pr Francis Veillon). * Subject (or the holders of parental authority in the case of minors) having agreed to the use of medical data for the purpose of this research. Cholesteatoma is a very common disease in the pediatric population, with important functional issues, whose treatment is surgical. That's why our study includes minor subjects. Criteria of non-inclusion * Refusal of the patient to pa…

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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
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5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

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1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
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6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

MRI imaging study to locate cholesteatoma.

Timeframe: The period from January 1st, 2010 to Dcember 31, 2017 will be examined

Trial details

NCT IDNCT03915392

SponsorUniversity Hospital, Strasbourg, France

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-07

Contact for this trial

Anne CHARPIOT, MD, PhD

33 3 88 12 76 49 anne.charpiot@chru-strasbourg.fr

View on ClinicalTrials.gov More Cholesteatoma trials