Balloon Dilation of the Eustachian Tube in Children

Study Overview
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Brief Summary
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Otitis media with effusion (OME) is very common in children and characterized by fluid in the middle ear without signs or symptoms of acute ear infection. Treatment options are tympanostomy tubes and/or adenoidectomy. However OME often reoccurs after these procedures. Goal of this study will be to evaluate the Balloon Eustachian Tuboplasty (BET) in children as an additional treatment option and to assess long-term effects of BET. Beside the standard procedure, children (4 to 10 years of age), with equal pathology on both ears, will be assigned for BET on side.

Detailed Description
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Introduction: Otitis media with effusion (OME, glue ear) is very common in children and characterized by fluid in the middle ear without signs or symptoms of acute ear infection. Fluid in the middle ear causes conducting hearing loss. OME has a large impact on health care costs and recurrent or persistent OME can effect the proper development of children. Frequently OME resolves itself, therefore guidelines strongly recommend watchful waiting for 3 months after which treatment options are tympanostomy tubes and/or adenoidectomy. However OME often reoccurs after these procedures. Furthermore there are various short and longterm side-effects of tympanostomy tubes.In Balloon Eustachian Tuboplasty (BET) a ballon catheter is used to dilate the cartilage part of the eustachian tube and is inserted through the nose to reach the opening of the tube, located in the nasopharynx. BET has recently been applied in children for therapy-resistant recurrent OME and inflammatory ear diseases with promising results. Risk and complications rates are very low. Methods: Goal of this study will be the evaluation of Balloon Eustachian Tuboplasty (BET) in children as a primary treatment of OME. Children between the ages of 4 and 10 years with OME and tympanometry type B on both ears, will prospectively be recruited and assigned for adenoidectomy and myringotomy. Parents then will be asked for participation in this trial and fully informed about purpose, technique and possible side effects. If consent is given, adenoidectomy, in case of large adenoids, and myringotomy will be performed on both sides. If necessary (very thick fluid) tympanostomy tubes are placed. One Eustachian tube of each patient is randomly assigned for BET.

Official Title
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Balloon Dilation of the Eustachian Tube in Children: a Randomized Side-controlled Clinical Trial

Conditions
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Glue Ear, Tube Disorders Eustachian

Intervention / Treatment
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* Procedure: Balloon Eustachian Tuboplasty (BET)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: OME on both sides measured by flat tympanometry Exclusion Criteria: Patients with cleft lip and/or palate and other severe craniofacial abnormalities

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: single-sided treatment, contralateral side with same pathology works as control
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Ear without BET<br>ear without BET treatment works as control | |
| Experimental: BET ear<br>ear with BET treatment works as intervention arm | Procedure: Balloon Eustachian Tuboplasty (BET)<br>* A balloon catheter is used to dilate the cartilage part of the eustachian tube and is inserted through the nose to reach the opening of the tube, located in the nasopharynx.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tympanometry-Change (Middle ear effusion/eardrum mobility assessed with Tympanometry) | Tympanometry, an objective test of middle-ear function, uses variations of air pressure in the ear canal to assess for middle ear effusion / eardrum mobility. | up to 3 months preoperatively and change to 3, 6 and 9 months postoperatively; | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Otoscopy score | 0= no effusion (Valsalva +/-, not feasible) retracted eardrum Fluid or bubbles through eardrum visible complete fluid blockage of middle ear | up to 3 months preoperatively and change to 3, 6 and 9 months postoperatively; |