Magnetic Resonance (MR) Imaging in the Post Operative Follow-up of Cholesteatoma in Children

Not Applicable

Completed

• Conditions: Cholesteatoma
• Interventions: Other: MR Imaging

• Registration Number: NCT00682409
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

Classical imaging techniques are inaccurate to detect residual cholesteatoma. The aim of our study is to evaluate the value of diffusion-weighted MR imaging and delayed contrast enhanced T1 weighted spin-echo sequences in the detection of residual cholesteatoma in children, in a large serie of surgically verified cases.

Detailed Description

Classical imaging techniques are inaccurate to detect residual cholesteatoma. Thin-section CT detects that the postoperative cavity is filled with a soft tissue mass. Classical MR imaging (T2 and T1 weighted spin-echo sequences) can not provide additionnal information about the nature of this filling : cholesteatoma, granulation or fibrous tissue.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-05-16
• Study First Submitted QC: 2008-05-20
• Study First Posted: 2008-05-22
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-27
• Last Update Posted: 2014-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• Female or male child enters 5 and 18 years
• Child having benefited from a surgical operation for cholesteatoma of the average ear acquired or congenital, one-sided or bilateral
• Child for whom an additional operating time is indicated
• Child without contraindication in the MRI
• Child having signed a enlightened assent
• Child among whom the parents or the legal representatives signed a enlightened assent

Exclusion Criteria

• Child of less than 5 years old and more than 18 years
• Child presenting a chronic renal insufficiency
• Child for whom an additional operating time is not indicated
• Child having a contraindication in the MRI
• Child not having signed the assent or the parents of which did not sign the assent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	MR Imaging	Analysis of the value of the imaging of distribution and the late sequence to differentiate the cholesteatoma of the fibrosis in the follow-up operating post at the child

Primary Outcome Measures

Name	Time	Method
Technical characteristics of the examination MRIs represented by the sensibility and the specificity of the test, with regard to the results stemming from the surgical operation	24 months

Secondary Outcome Measures

Name	Time	Method
Only a surgical operation will confirm the diagnosis of cholesteatoma doing it again or residual.	24 months
It is necessary to test the following diagnostic method: the analysis of the morphological sequences in T1 and in T2 will allow to appreciate the existence or not of a filling of the cavity tympanique or the mastoïde and to clarify its localization.	24 months

Trial Locations

Locations (1)

Hôpital de la Timone- Service de radiologie pédiatrique et d'ORL pédiatrique; 🇫🇷 Marseille, France