Balloon Eustachian Tuboplasty in Treatment of Chronic Eustachian Tube Dysfunction

Study Overview
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Brief Summary
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The prevalence of Eustachian tube (ET) dysfunction in adults reaches 1%. It causes a feeling of fullness in the ear, otalgia and hearing loss and can lead to recurrent acute otitis media, development of chronic otitis media with effusion and cholesteatoma. Endoscopic transnasal balloon ET dilatation is a novel surgical technique for ET dysfunction. The main goal is to restore ET function by dilation its cartilaginous part leading to better ventilation and drainage of the middle ear. However, its real effect in the treatment of particular subgroups of patients with ET dysfunction remains unknown. Patients are mostly evaluated as one group. Adults with chronic ET dysfunction will be strictly divided into particular subgroups and included in the study. Subgroups will be compared in order to identify treatment effect in particular subgroups.

Detailed Description
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The prevalence of Eustachian tube (ET) dysfunction in adults reaches 1%. It causes a feeling of fullness in the ear, otalgia and hearing loss and can lead to recurrent acute otitis media, development of chronic otitis media with effusion and cholesteatoma. Endoscopic transnasal balloon ET dilatation is a novel surgical technique for ET dysfunction. The main goal is to restore ET function by dilation its cartilaginous part leading to better ventilation and drainage of the middle ear. However, its real effect in the treatment of particular subgroups of patients with ET dysfunction remains unknown. Patients are mostly evaluated as one group. Adults with chronic ET dysfunction will be strictly divided into particular subgroups and included in the study. The otomicro(endo)scopy, symptoms severity according to VAS (Visual Analogue Pain Scale), ETDQ-7 (Eustachian Tube Dysfunction Questionnaire) questionnaire, tympanometry, audiometry and the possibility of Valsalva and Toynbee maneuver will be used to evaluate the effect of balloon ET dilatation. Only patients with standard treatment failure will be included in the study. Tuboplasty with and without myringotomy will be performed (and compared) in patients with chronic otitis media with effusion. Subgroups will be compared in order to find patients who could profit from the treatments the most.

Official Title
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Balloon Eustachian Tuboplasty in Treatment of Chronic Eustachian Tube Dysfunction

Conditions
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Chronic Eustachian Tube Dysfunction, Chronic Recurrent Otitis Media, Effusion After Tympanostomy

Intervention / Treatment
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* Device: Eustachian tube dilatation device
* Procedure: Myringotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients with chronic Eustachian tube dysfunction lasting more than 6 months, with or without recurrence of chronic otitis media with effusion after tympanostomy Exclusion Criteria: anatomic obstruction in nasopharynx nasopharyngeal cancer head and neck cancer other middle ear surgery except for myringotomy or tympanostomy chronic suppurative otitis media patients who could not undergo general anesthesia patients who did not give consent to be included in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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: Interventional parallel randomized controlled prospective trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Effusion, Eustachian tube dilatation device and myringotomy<br>Patients with chronic Eustachian tube dysfunction and recurrence of chronic otitis media with effusion after tympanostomy tube exclusion, intervention: balloon Eustachian tuboplasty, and myringotomy | Device: Eustachian tube dilatation device<br>* Balloon Eustachian tuboplasty will be performed using a Eustachian tube dilatation device.<br>Procedure: Myringotomy<br>* Myringotomy will be performed using a standard procedure.<br>|
| Experimental: Effusion, Eustachian tube dilatation device<br>Patients with chronic Eustachian tube dysfunction and recurrence of chronic otitis media with effusion after tympanostomy tube exclusion, intervention: balloon Eustachian tuboplasty only (no myringotomy) | Device: Eustachian tube dilatation device<br>* Balloon Eustachian tuboplasty will be performed using a Eustachian tube dilatation device.<br>|
| Experimental: No effusion, Eustachian tube dilatation device<br>Patients with chronic Eustachian tube dysfunction and airy middle ear (without otitis media with effusion), Eustachian tube dilatation device, no myringotomy | Device: Eustachian tube dilatation device<br>* Balloon Eustachian tuboplasty will be performed using a Eustachian tube dilatation device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Otomicro(endo)scopy | Otomicro(endo)scopy will be used to assess the presence or absence of effusion. | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms severity according to Visual Analogue Scale | Symptoms severity will be assessed on Visual Analogue Scale (on the scale of 1-10). Visual Analogue Scale is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. | 36 months | 
| ETDQ-7 questionnaire | The patients will be asked to fill-in the Eustachian Tube Dysfunction Questionnaire in order to assess the symptoms of Eustachian Tube Dysfunction (ETD). The ETDQ-7 is a valid and reliable symptom score for use in adult patients with ETD. The ETDQ-7 tool consists of seven items with a scale of graduated responses ranging from 1 to 7, with 1 corresponding to the absence of the suggested symptom and 7, to maximum symptom severity. | 36 months | 
| Tympanometry | Type of tympanometry curve (A, B, C) according to Joerger et al. | 36 months | 
| Audiometry | Hearing loss according to WHO classification (mild, moderate, severe). | 36 months | 
| Tubomanometry | Assessment of opening pressure in Eustachian tube in mmHg. | 36 months | 
| Possibility of Valsalva and Toynbee manoeuvre | The possibility or inability of Valsalva and Toynbee manoeuvre (yes/no) | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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otitis media with effusion, balloon tuboplasty, Eustachian tube, Eustachian tube dysfunction