Long-term Assessment of Balloon Eustachian Tuboplasty for Obstructive Eustachian Tube Disease

NCT05998356 | Not Yet Recruiting

• 1 other identifier: RECHMPL22_0551
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

To date, more than 130 000 Balloon Eustachian Tuboplasty (BET) procedures have been performed worldwide. This procedure is proposed in case of Obstructive Eustachian Tube Dysfunction (OETD) with or without chronic otitis media. However, the effectiveness of this procedure is still discussed amongst otolaryngologist. Most of studies,were open label prospective studies comparing Eustachian tube function before and after surgical treatment. A recent meta-analysis suggests that BET procedure improves postoperative Eustachian tube function, but high-level evidence is still lacking. In this project, the investigators propose to perform the first blinded randomized controlled trial procedure to assess the changes of Eustachian tube function after BET in a population of subjects with chronic OETD with or without chronic otitis. Prognosis factors of efficacy will be also investigated during the study.

Conditions

Eustachian Tube Dysfunction

Keywords

Eustachian tube; Balloon Eustachian Tuboplasty; Eustachian Tubal Score

Outcome Measures

Primary Outcomes (1)

• Eustachian Tubal Score (ETS)

  The changes of Eustachian tube function will be addressed by the calculation of the difference between final (v4) and initial (v1) Eustachian Tubal Score (ETS). The ETS score is a composite score considering objective measures (tubomanometry, tympanic impedancemetry) and subjective measures (Valsalva maneuver efficacy, opening of the Eustachian tube).ETS score is highly correlated to tubal function.

  ETS is calculated at the inclusion, between 2 and 5 months after the inclusion, and between 6 and 9 months after the inclusion

Secondary Outcomes (2)

• Tympanic impedancemetry

  The measurement is performed at the inclusion, between 2 and 5 months after the inclusion, and between 6 and 9 months after the inclusion

• Specific Eustachian tube dysfunction score

  The ETDQ-7 questionnary is performed at the inclusion, between 2 and 5 months after the inclusion, and between 6 and 9 months after the inclusion

Study Arms (2)

Intervention group (BET procedure)

EXPERIMENTAL

Subjects randomly assigned to the intervention group will benefit from BET procedure

Device: Balloon Eustachian Tuboplasty (BET) under general anesthesia.

Control group

PLACEBO COMPARATOR

Subjects from control group will undergo insertion of catheter for probing and flushing the Eustachian tube, the catheter won't be dilated

Device: Insertion of catheter for probing and flushing the Eustachian tube under general anesthesia

Interventions

Balloon Eustachian Tuboplasty (BET) under general anesthesia. DEVICE

Subjects will undergo general anesthesia with intubation. After retraction of the inferior turbinate using Naphazoline, the balloon will be inserted under optical control through the pharyngeal ostium of the Eustachian tube and inflated two times at a pressure of 10 bars as instructed by the manufacturer.

Intervention group (BET procedure)

Insertion of catheter for probing and flushing the Eustachian tube under general anesthesia DEVICE

Participants in the control group will benefit from the insertion of a dedicated catheter, TubaClean, into the Eustachian tube during 2 minutes with gentle washing with saline solution, and then the catheter will be removed. This type of device is used to wash the Eustachian tube lumina during ear surgery. Thus, the procedure in the control group will be very close to the BET, except that no dilation will be performed. No Eustachian tube dilation will occur in this control group since the diameter of the catheter itself is not large enough to cause dilation. Eustachian tube catheterization is not per se a treatment of ETD but just of mucosal plugs, and the investigators expect no effect of this catheter insertion on the outcomes of the study. At the end of the procedure, subjects will have nasal dressings similar to the BET procedure to ensure the blinding of the study.

Control group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 85 years
• Clinical symptoms of OETD with Eustachian tubal score less or equal to 7/14
• Failure of well conducted medical treatment (GERD, allergy, rhinosinusitis) including pressure equalization device used for 1 month or more
• ASA score 1 or 2 (ASA : American Society of Anesthesiologists)

You may not qualify if:

• Palatal cleft
• Anatomical anomaly of pharyngeal Eustachian tube ostium on the treated side
• Medical history of nasopharyngeal radiotherapy
• Medical history of middle ear surgery (except myringotomy and/or tympanostomy tube)
• Eardrum perforation in the treated side
• Contraindication of general anesthesia, or major risk of general anesthesia including ASA scores of 3 and 4
• Major nasal obstruction ipsilateral to the Eustachian tube to treat
• Medical history of previous Eustachian Tube Dilation
• Pregnant or nursing woman, or in childbearing age and not willing to use contraception
• Protected and vulnerable adult
• Not covered by Health insurance
• Refusal to sign informed consent form
• Subjects unable to attend all scheduled visits or to comply with all trial procedures

Sponsors & Collaborators

• University Hospital, Montpellier: lead

MeSH Terms

Interventions

Catheterization

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Officials

• Frédéric Venail, MD, PhD

  University hospital of Montpellier, FRANCE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia Korchagina, PhD

CONTACT

+33 4 67 33 61 56; julia.korchagina@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The subjects will be blinded to the treatment arm, while surgeons cannot be blinded for obvious reasons. The data collection from post-operative visits will be performed by assessors blinded to the inclusion arm to minimize possible biases.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects randomly assigned to the intervention (experimental) group will benefit from BET, and subjects in the control group will undergo a Eustachian tube catheter insertion for probing and flushing the Eustachian tube but without dilation.

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: August 18, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 21, 2023

Record last verified: 2023-09