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Trial registered on ANZCTR


Registration number
ACTRN12618001681246
Ethics application status
Approved
Date submitted
8/10/2018
Date registered
11/10/2018
Date last updated
11/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Balloon Dilatation for Eustachian Tube Obstruction: A Randomised Control Trial
Scientific title
A Randomised Control Trial assessing improvement in objective and subjective measures of Eustachian tube function after Transnasal Balloon Dilatation for Eustachian Tube obstruction.
Secondary ID [1] 296302 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eustachian tube dysfunction 309851 0
Condition category
Condition code
Ear 308641 308641 0 0
Other ear disorders
Ear 308642 308642 0 0
Normal ear development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 312544 0
Treatment: Devices
Intervention code [2] 312545 0
Treatment: Drugs
Comparator / control treatment
The control group in this study will be treated with medical management alone.

Patients randomised to medical management alone will commence the same mometasone nasal steroid spray regimen for a planned period of 6 weeks on the day of randomisation. Again, continuation of therapy after the 6-week period will be at the discretion of the patient’s surgeon. The medical management group will have the opportunity to move into the active intervention group after 6 weeks, and if they decide to do this, there will be no washout period.

Throughout the duration of study participation, subjects will be permitted to continue any concomitant medications for their ETDD or other medical conditions (i.e., allergic rhinitis, laryngopharyngeal reflux) deemed clinically necessary, per their surgeon’s discretion. Subjects will not be permitted to start any new medications or to increase the dose or frequency for existing concomitant medications. Patients requiring such alterations or the commencement of new medications for medically indicated reasons will be excluded from the study.
Control group
Active

Outcomes
Primary outcome [1] 307601 0
Change in middle ear function by assessment of tympanometry
Timepoint [1] 307601 0
6 weeks following the primary intervention
Secondary outcome [1] 352388 0
Change in severity of subjective Eustachian Tube Dysfunction by assessment of ETDQ-7 scores
Timepoint [1] 352388 0
6 weeks following the primary intervention

Eligibility
Key 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
Minimum age
22 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/10/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 12035 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 12036 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 12037 0
North Shore Private Hospital - St Leonards
Recruitment hospital [4] 12038 0
Macquarie University Hospital - Macquarie Park
Recruitment postcode(s) [1] 24193 0
2065 - St Leonards
Recruitment postcode(s) [2] 24194 0
2050 - Camperdown
Recruitment postcode(s) [3] 24195 0
2109 - Macquarie Park

Funding & Sponsors
Funding source category [1] 300470 0
Other Collaborative groups
Name [1] 300470 0
Kolling Deafness Research Centre
Country [1] 300470 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Kolling Deafness Research Centre
Address
Kolling Deafness Research Centre
Royal North Shore Hospital, Pacific Hwy
St Leonards, NSW, 2065
Australia
Country
Australia
Secondary sponsor category [1] 300356 0
None
Name [1] 300356 0
Address [1] 300356 0
Country [1] 300356 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301272 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 301272 0
NSLHD Research Office
Level 13, Kolling Building
Royal North Shore Hospital
St Leonards NSW 2065
Ethics committee country [1] 301272 0
Australia
Date submitted for ethics approval [1] 301272 0
Approval date [1] 301272 0
27/08/2018
Ethics approval number [1] 301272 0
RESP/18/131

Summary
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.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3125 3125 0 0
/AnzctrAttachments/375846-PROTOCOL -Balloon Dilatation for Eustachian Tube Obstruction - A Randomised Control Trial.pdf (Protocol)
Attachments [2] 3126 3126 0 0
/AnzctrAttachments/375846-ARTG certificate -Catheter eustachian.pdf (Other)
Attachments [3] 3127 3127 0 0
/AnzctrAttachments/375846-ARTG certificate -Catheter balloon inflation system.pdf (Other)

Contacts
Principal investigator
Name 86442 0
Dr Nicholas Jufas
Address 86442 0
Department of Otolaryngology
Royal North Shore Hospital,
Reserve Rd, St Leonards, NSW, 2065,
Australia
Country 86442 0
Australia
Phone 86442 0
+61 (02) 9926 7111
Fax 86442 0
Email 86442 0
[email protected]
Contact person for public queries
Name 86443 0
Nicholas Jufas
Address 86443 0
Department of Otolaryngology
Royal North Shore Hospital,
Reserve Rd, St Leonards, NSW, 2065,
Australia
Country 86443 0
Australia
Phone 86443 0
+61 (02) 9926 7111
Fax 86443 0
Email 86443 0
[email protected]
Contact person for scientific queries
Name 86444 0
Nicholas Jufas
Address 86444 0
Department of Otolaryngology
Royal North Shore Hospital,
Reserve Rd, St Leonards, NSW, 2065,
Australia
Country 86444 0
Australia
Phone 86444 0
+61 (02) 9926 7111
Fax 86444 0
Email 86444 0
[email protected]

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Results publications and other study-related documents

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