Balloon Eustachian Tuboplasty in Treatment of Chronic Eustachian Tube Dysfunction

University Hospital Ostrava

Status: Completed

Conditions: Effusion After Tympanostomy; Chronic Eustachian Tube Dysfunction; Chronic Recurrent Otitis Media

Treatments: Procedure: Myringotomy; Device: Eustachian tube dilatation device

Study type: Interventional

Funder types: Other

Identifiers

NCT03556215

FNO-ENT-BET

MH CZ - DRO - FNOs/2016 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 3 patient groups

Effusion, Eustachian tube dilatation device and myringotomy

Experimental group

Description:

Patients with chronic Eustachian tube dysfunction and recurrence of chronic otitis media with effusion after tympanostomy tube exclusion, intervention: balloon Eustachian tuboplasty, and myringotomy

Treatment:

Device: Eustachian tube dilatation device

Procedure: Myringotomy

Effusion, Eustachian tube dilatation device

Experimental group

Description:

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)

Treatment:

Device: Eustachian tube dilatation device

No effusion, Eustachian tube dilatation device

Experimental group

Description:

Patients with chronic Eustachian tube dysfunction and airy middle ear (without otitis media with effusion), Eustachian tube dilatation device, no myringotomy

Treatment:

Device: Eustachian tube dilatation device