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NCT Number: NCT03556215

Balloon Eustachian Tuboplasty in Treatment of Chronic Eustachian Tube Dysfunction

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.

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Key information

Conditions

Chronic Eustachian Tube Dysfunction Chronic Recurrent Otitis Media Ear Diseases Effusion After Tympanostomy Otitis Otitis Media Otitis Media with Effusion Otorhinolaryngologic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Hradec Králové, Hradec Králové, Hradec Králové Region, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eustachian tube dilatation device

Device

Balloon Eustachian tuboplasty will be performed using a Eustachian tube dilatation device.

Myringotomy

Procedure

Myringotomy will be performed using a standard procedure.

Primary outcomes

  1. Otomicro(endo)scopy

    Time frame: 36 months

    Otomicro(endo)scopy will be used to assess the presence or absence of effusion.

Secondary outcomes

  1. Symptoms severity according to Visual Analogue Scale

    Time frame: 36 months

    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.

  2. ETDQ-7 questionnaire

    Time frame: 36 months

    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.

  3. Tympanometry

    Time frame: 36 months

    Type of tympanometry curve (A, B, C) according to Joerger et al.

  4. Audiometry

    Time frame: 36 months

    Hearing loss according to WHO classification (mild, moderate, severe).

  5. Tubomanometry

    Time frame: 36 months

    Assessment of opening pressure in Eustachian tube in mmHg.

  6. Possibility of Valsalva and Toynbee manoeuvre

    Time frame: 36 months

    The possibility or inability of Valsalva and Toynbee manoeuvre (yes/no)

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Collaborators

  • University Hospital Hradec Kralove

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jun 14, 2018
Registry last updated
Dec 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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