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

Optimal Duration of Magnetic Resonance Imaging (MRI) Follow-up to Safely Identify Middle Ear Residual Cholesteatoma

Sponsors

Lead Sponsor: University Hospital, Montpellier

Source University Hospital, Montpellier
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

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.

Overall Status Completed
Start Date January 1, 2013
Completion Date December 31, 2019
Primary Completion Date December 1, 2019
Study Type Observational
Primary Outcome
Measure Time Frame
MRI sensitivity and specificity values as a function of the duration of the follow-up 1 day
Secondary Outcome
Measure Time Frame
Receiver operating characteristics (ROC) curves 1 day
Enrollment 17
Condition
Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Frederic Venail, MD, PhD Study Director University Hospital, Montpellier
Location
Facility: Uhmontpellier
Location Countries

France

Verification Date

July 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Patient Data Undecided
Study Design Info

Observational Model: Cohort

Time Perspective: Retrospective

Source: ClinicalTrials.gov