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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04489550

Enrollment

Registered

2020-07-28

Start date

2013-01-01

Completion date

2019-12-31

Last updated

2020-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Middle Ear Cholesteatoma

Keywords

residual cholesteatoma, imaging follow-up, canal wall-up tympanoplasty, non-EP DWI

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Receiver operating characteristics (ROC) curves	1 day	the receiver operating characteristics (ROC) curves

Countries

France

Outcome results