Diffusion Weighted MRI Accuracy in Cholesteatoma Localization

NCT03915392 | Unknown

• 1 other identifier: 7122
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Cholesteatoma

Keywords

Diffusion weighted MRI; Cholesteatoma; Localization

Outcome Measures

Primary Outcomes (1)

• MRI imaging study to locate cholesteatoma.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent cholesteatoma surgery between January 1, 2010 and December 31, 2017

You may qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service D'Orl Et de Chirurgie Cervico-Faciale

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Cholesteatoma

Condition Hierarchy (Ancestors)

Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Anne CHARPIOT, MD, PhD

  University Hospital, Strasbourg, France

  STUDY DIRECTOR

Central Study Contacts

Anne CHARPIOT, MD, PhD

CONTACT

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

Antoine MERANGER, MD

CONTACT

33 3 88 12 76 49; antoine.meranger@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2018
• First Posted: April 16, 2019
• Study Start: July 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: April 16, 2019

Record last verified: 2018-09

Locations

FR (1)