None listed
Conditions
Brief summary
The eustachian tube constitutes a natural conduit between the middle ear (ME) and the nasopharynx and is essential for normal ME function. Eustachian tube dilatory dysfunction (ETDD) causes inadequate ventilation of the ME and is associated with significant morbidity. Several treatments have been proposed to treat ETDD, including breathing manoeuvres, pharmacological agents, mechanical devices and nasal surgery, though these methods have had limited success and can be ineffective at treating the underlying tubal dysfunction. Recently, catheter assisted balloon dilatation of the eustachian tube (BDET) has been undertaken as a means of improving ME ventilation and eustachian tube compliance with safety and success for the treatment of persistent ETDD. The proposed study aims to assess the effectiveness of the Spiggle and Theis Medizentechnik balloon catheter system for the treatment of ETDD in conjunction with medical management (MM) of ETDD compared with MM alone. Participants with a diagnosis of ETTD who consent, will be randomised to BDET + MM or MM alone and followed up at 2,6,12 and 24 weeks. They will undergo repeat examination and tympanometry to examine for resolution of ETDD. The primary outcome measure for the study will be normalisation of tympanometry at 6 weeks post intervention. For patients in the control group that elect to do so, they will be permitted to undergo the intervention intervention. The proposed study is a prospective multicenter, non-significant risk, randomised control trial that has been designed to demonstrate the superiority of balloon dilatation of the eustachian tube using a eustachian tube balloon catheter plus medical management when compared to medical management alone for the treatment of ETDD.
Interventions
The intervention group will undergo balloon dilatation of the eustachian tube (ET) in addition to medical management for the treatment of obstructive ET dysfunction.
Balloon dilation of the ET will be performed under general anesthesia in the operating room by trained and accredited otolaryngologists as recognized by the Royal Australian College of Surgeons (RACS). All of the surgeons involved in the study are skilled in the proposed procedure and have performed multiple successful balloon dila
The intervention group will undergo balloon dilatation of the eustachian tube (ET) in addition to medical management for the treatment of obstructive ET dysfunction. Balloon dilation of the ET will be performed under general anesthesia in the operating room by trained and accredited otolaryngologists as recognized by the Royal Australian College of Surgeons (RACS). All of the surgeons involved in the study are skilled in the proposed procedure and have performed multiple successful balloon dilatations of the eustachian tube for the treatment of eustachian tube dilatory dysfunction prior to the commencement of the study. Each ET dilatation will be performed using a standardized technique. Patients will receive general anesthesia by a accredited anaesthetist. The nasal cavity on the affected side will be decongested using 3mls of oxymetazoline instilled into the nasal cavity. If the patient is undergoing bilateral dilatation then both nasal cavities will be decongested. Rigid nasendoscopy will be used in all cases to allow examination of the nasal cavity and facilitate safe and accurate placement of the balloon catheter into the ET. With the aid of nasendoscopy (a small fiberoptic camera inserted through the nose), a single use introducer will inserted into the nasal passage on the affected side so that is passes to the back of the nasal cavity and nasopharynx. The angled introducer is then pointed towards the affected ET opening. A single use catheter with a balloon tip is then inserted through the introducer and emerges from the angled end into the opening of the ET. The catheter is then advanced into the ET under visualization until the indicator line on the catheter emerges from the introducer, signifying that the catheter has been sufficiently advanced. The balloon is then inflated with sterile isotonic saline solution (NaCl 0.9%) for a period of 2 minutes using the included insufflator, to an inflation pressure of 10 to 12 atmospheres while the balloon is held in situ. At the conclusion of the 2-minute period, the balloon is deflated and pulled back out of the ET so that it re-enters the introducer. The balloon catheter and introducer are then removed together form the nasal cavity. If the patient has bilateral disease and both ETs require treatment, the procedure is repeated on the other side in the same way. It is expected the entire procedure, including the general anaesthetic itself will take around 20 minutes and will be performed as day surgery. For patients randomized to receive BDET in conjunction with medical management, medical management was initiated on the day of surgery. Participants will be prescribed a regimen of mometasone nasal steroid spray (Brand name: Nasonex), consisting of two sprays to each nostril once per day for a period of 6 weeks time. (50 mcg of mometasone furoate in each spray, total daily dose of 200 mcg). Participants will be educated on how to effectively undertake this by their surgeon. After 6 weeks, continuation of medical therapy will be at the discretion of the patient’s surgeon. Compliance with nasal spray will be monitored with participant diaries.
Sponsors
Kolling Deafness Research Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be eligible to enroll in the study patients must: • Provide informed consent to participate in the study • Have a diagnosis of persistent ETDD (A positive diagnosis is confirmed by the presence of abnormal tympanometry and symptomatic dysfunction as documented by the ETDQ-7 questionnaire mean item score greater than 2.1, for 12 weeks or more prior to enrollment in the study) • Be 22 years of age or older with persistent ETDD and have failed medical management consisting of either 4 weeks of continuous daily usage of intranasal corticosteroids spray or a minimum of 1 completed course of oral steroids within 90-days prior to study enrollment. • Have a recent (or be able to undergo a) CT petrous temporal bone • Be able to undergo fibreoptic nasendoscopy
Exclusion criteria
Exclusion criteria include the following: • Anatomy that requires an adjunctive surgical procedure • Planned concomitant nasal, sinus or ear procedures during the study • History of major head and neck surgery within 4 months or randomization • History of head and neck radiation • Diagnosis of patulous eustachian tube • Fluctuating sensorineural hearing loss • Active acute or chronic otitis media • Tympanic membrane perforation or the presence of a tympanostomy tube (grommet) • Presence of tympanosclerosis • Acute upper respiratory tract infection • Active temporomandibular joint disorder • Cleft palate or a history of cleft palate repair • History of craniofacial syndrome • History of cystic fibrosis • History of ciliary dysmotility syndrome • History of systemic mucosal diseases or immunodeficiency disorders • Intolerance of protocol-defined medication regimen • Prior surgical ET intervention • Limited dilatory muscular contractions on endoscopy of the ET • Contraindications to BDET
Outcome results
None listed