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.
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)
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)
Parallel
Balloon Eustachian Tuboplasty (BET) under general anesthesia.
DeviceSubjects 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.
Insertion of catheter for probing and flushing the Eustachian tube under general anesthesia
DeviceParticipants 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.
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.
Tympanic impedancemetry
Tympanic impedancemetry will classify ear impedancetry as normal (A) or abnormal (B or C type curves)
Specific Eustachian tube dysfunction score
Specific Eustachian tube dysfunction score will be assessed by the ETDQ-7 questionary that has been shown to be sensitive and specific for Eustachian tube diseases.
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