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Balloon dilation for persistent unilateral chronic obstructive Eustachian tube dysfunction is effective: a prospective multicentre study

  • Otology
  • Published:
European Archives of Oto-Rhino-Laryngology Aims and scope Submit manuscript

Abstract

Purpose

Balloon dilatation of the Eustachian tube (BDET) is an option for treating chronic obstructive Eustachian tube dysfunction (COETD). In this prospective multicentric study, the main objective was to evaluate the results of BDET in unilateral COETD refractory to medical treatment.

Methods

Adults with unilateral COETD whose Eustachian Tube Score (ETS) was less than 5 despite medical pressure therapy were included. The primary endpoint was the change in ETS measured at 2, 6, and 12 months after BDET. Secondary objectives were the evolution of clinical symptoms assessed by the Eustachian Tube Questionnaire (ETDQ-7), audiometry, tympanometry, and otoscopy changes after BDET.

Results

Twenty-eight patients were included between May 2014 and December 2017 and were treated with BDET without adverse effects in three different referral centers. Population’s median age was 52 (Q25; Q75: 24, 82) years. The median follow-up time was 381 (Q25; Q75: 364; 418) days. The median ETS was 2 (Q25; Q75: 1; 4) before BDET. There was a significant improvement in ETS at 2 and 6 months and 1 year after BDET (score at 1 year: 6 (Q25; Q75: 2; 8) (p < 0.0001)). There was a significant, sustained improvement in the ETDQ-7 with a score of 4.21 (Q25; Q75–3.50; 4.79) before BDET and 3.43 (Q25; Q75–2.43; 4.14) (p = 0.0012) at 1 year. There was a suggestive improvement in tympanometry results at 1 year (p = 0.025).

Conclusion

BDET provides an improvement in symptoms and objective measures assessed at 1 year in patients with COETD who have failed medical treatment.

Trial Registration: NCT02123277 (April 25, 2014).

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Acknowledgements

We thank Federico Manna for his help with data management and statistical analysis.

Funding

This study was financed by a French research program (Programme Hospitalier de Recherche Clinique-Interrégional—DGOS 2013-A01696-39).

Author information

Authors and Affiliations

  1. Oto-Rhino-Laryngology-Head and Neck Surgery Department, Montpellier University, CHU Gui de Chauliac, 80 Avenue Augustin Fliche, 34295, Montpellier, France

    Akil Kaderbay, David Schmitt & Frédéric Venail

  2. Oto-Rhino-Laryngology-Head and Neck Surgery Department, Aix-Marseille University, Assistance Publique des Hôpitaux de Marseille, Marseille, France

    Jean Pierre Lavieille

  3. Oto-Rhino-Laryngology, Head and Neck Surgery Department, Saint-Etienne University, Hôpital Nord, Saint Etienne, France

    Alexandre Karkas

  4. Medical Information Department, Montpellier University, CHU La Colombière, Montpellier, France

    Thibault Mura

  5. Neurosciences Institute of Montpellier, INSERM U1298 and Montpellier University, Montpellier, France

    Frédéric Venail

Authors
  1. Akil Kaderbay
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  2. Alexandre Karkas
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  3. David Schmitt
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  4. Thibault Mura
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  5. Jean Pierre Lavieille
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  6. Frédéric Venail
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Contributions

All authors contributed to the study conception and design. The first draft of the manuscript was written by Akil KADERBAY and all authors commented on previous versions of the final manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Akil Kaderbay.

Ethics declarations

Ethical approval

The study was approved by the Bioethics Committee of the Medical University Hospital and was registered on www.clinicaltrials.gov (NCT02123277). Each patient received information orally and signed a written consent before inclusion. The study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

Conflict of interest

The authors declare that they have no conflict of interest. Frédéric Venail has been granted by the « Fondation pour l’Audition « (RD- 2020-10).

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Kaderbay, A., Karkas, A., Schmitt, D. et al. Balloon dilation for persistent unilateral chronic obstructive Eustachian tube dysfunction is effective: a prospective multicentre study. Eur Arch Otorhinolaryngol 280, 1101–1109 (2023). https://doi.org/10.1007/s00405-022-07578-2

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  • DOI: https://doi.org/10.1007/s00405-022-07578-2

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