Balloon Eustachian Tuboplasty in Treatment of Chronic Eustachian Tube Dysfunction

NCT03556215 | Completed

• 2 other identifiers: FNO-ENT-BETMH CZ - DRO - FNOs/2016
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

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

Keywords

otitis media with effusion; balloon tuboplasty; Eustachian tube; Eustachian tube dysfunction

Outcome Measures

Primary Outcomes (1)

• Otomicro(endo)scopy

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

  36 months

Secondary Outcomes (6)

• Symptoms severity according to Visual Analogue Scale

  36 months

• ETDQ-7 questionnaire

  36 months

• Tympanometry

  36 months

• Audiometry

  36 months

• Tubomanometry

  36 months

Study Arms (3)

Effusion, Eustachian tube dilatation device and myringotomy

EXPERIMENTAL

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; Procedure: Myringotomy

Effusion, Eustachian tube dilatation device

EXPERIMENTAL

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

No effusion, Eustachian tube dilatation device

EXPERIMENTAL

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

Interventions

Eustachian tube dilatation device DEVICE

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

Effusion, Eustachian tube dilatation device; Effusion, Eustachian tube dilatation device and myringotomy; No effusion, Eustachian tube dilatation device

Myringotomy PROCEDURE

Myringotomy will be performed using a standard procedure.

Effusion, Eustachian tube dilatation device and myringotomy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients with chronic Eustachian tube dysfunction lasting more than 6 months, with or without recurrence of chronic otitis media with effusion after tympanostomy

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Ostrava: lead
• University Hospital Hradec Kralove: collaborator

Study Sites (2)

University Hospital Hradec Králové

Hradec Králové, Hradec Králové Region, 500 05, Czechia

Location

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 708 52, Czechia

Location

Related Publications (1)

• Swords C, Smith ME, Patel A, Norman G, Llewellyn A, Tysome JR. Balloon dilatation of the Eustachian tube for obstructive Eustachian tube dysfunction in adults. Cochrane Database Syst Rev. 2025 Feb 26;2(2):CD013429. doi: 10.1002/14651858.CD013429.pub2.

  PMID: 40008607 DERIVED

MeSH Terms

Conditions

Otitis Media with Effusion

Interventions

Middle Ear Ventilation

Condition Hierarchy (Ancestors)

Otitis Media; Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Ostomy; Surgical Procedures, Operative; Otologic Surgical Procedures; Otorhinolaryngologic Surgical Procedures

Study Officials

• Pavel Komínek, prof.,MD,Ph.D.,MBA

  University Hospital Ostrava

  STUDY CHAIR

• Martin Formánek, MD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking was used in the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional parallel randomized controlled prospective trial

Study Record Dates

• First Submitted: May 20, 2018
• First Posted: June 14, 2018
• Study Start: May 1, 2016
• Primary Completion: May 31, 2020
• Study Completion: November 30, 2020
• Last Updated: December 7, 2022

Record last verified: 2022-12

Locations

CZ (2)