Balloon Eustachian Tuboplast (BET)
| ISRCTN | ISRCTN02147658 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02147658 |
| Secondary identifying numbers | N/A |
- Submission date
- 02/12/2011
- Registration date
- 28/12/2011
- Last edited
- 09/09/2013
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Ear, Nose and Throat
Plain English Summary
Background and study aims?
The Eustachian tube is a narrow tube that connects the middle ear with the back of the nose. If it is blocked, it can cause muffled hearing or hearing loss, pain, a feeling of fullness in the ear. At the moment, persistent Eustachian tube dysfunction is commonly treated by inserting a tympanostomy tube (also known as a ventilation tube or grommet) through a small incision on the ear drum. Associated risks includes crusting, infection, obstruction and permanent tympanic membrane perforation. Repeated tube insertions may also be required. Special long-acting tubes are sometimes used but these are subject to increased risks. Patients with hearing loss may decide to use hearing aids. Balloon dilatation of the Eustachian tube is used in adults with the aim of
widening the Eustachian tube and improving its function.
Who can participate?
To take part the doctor needs to confirm that your Eustachian tube is blocked on one or both sides. Both male and female can participate, but you need to be 18 years or older.
What does the study involve?
Balloon dilatation of the Eustachian tube is usually performed with the patient under general anaesthesia. A balloon catheter is introduced into the Eustachian tube via the nose. Once the balloon is correctly positioned in the cartilaginous portion of the Eustachian tube, it is filled with saline up to a pressure of about 10 bars. Pressure is maintained for approximately 2 minutes. The balloon is then emptied and removed. Patients who have problems with both Eustachian tubes will be randomly allocated to one of two groups (either the right or the left side will be dilated). A tympanostomy tube (also known as a ventilation tube or grommet) will be inserted in the other ear.
What are the possible benefits and risks of participating?
The absence of an indwelling grommet is a significant benefit of the new procedure. The minimally invasive nature of the procedure reduces the possibility of complications. Risks may include damage or narrowing of the Eustachian tube, scarring, ear infection, pain and permanent hearing loss. In theory, there is a risk of rupture of a major artery (the internal carotid artery).
Where is the study run from?
North Bristol NHS Trust Hospitals.
When is study starting and how long is it expected to run for?
The anticipated start date is January 2012 (or soon after) and the approximate duration of the trial is two years. Follow up will continue for two years after.
Who is funding the study?
North Bristol NHS Trust
Who is the main contact?
Mrs Adenike Oluwasanmi
Adenike.Oluwasanmi@nbt.nhs.uk
Contact information
Scientific
ENT Department
Southmead Hospital
Westbury on Trym
Bristol
BS10 5NB
United Kingdom
| Phone | +44(0)7985 544 850 |
|---|---|
| Adenike.Oluwasanmi@nbt.nhs.uk |
Study information
| Study design | Randomised controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effect of Balloon dilatation on Eustachian Tube dysfunction: a randomised controlled study |
| Study acronym | BET |
| Study hypothesis | Long-term Eustachian tube dysfunction is associated with damage to the eardrum and middle-ear transformer mechanism. Symptoms of this are: muffled hearing, pain, a feeling of fullness in the ear. Tinnitus or dizziness may also occur. Hypothesis: Dilating the Eustachian tube should improve its function and improve middle ear function thus reducing the incidence of diseases like glue ear etc |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Long-term Eustachian tube dysfunction |
| Intervention | Patients who has problems with both Eustachian tubewill be randomized to decide which side (right or left) to dilate. A tympanostomy tube(also known as a ventilation tube or grommet) will be inserted in the other ear. A balloon catheter is introduced into the Eustachian tube via the nose, under transnasal endoscopic vision. Once the balloon is correctly positioned in the cartilaginous and bony portion of the Eustachian tube, it is filled with saline up to a pressure of about 10 bars. Pressure is maintained for approximately 2 minutes. The balloon is then emptied and removed |
| Intervention type | Other |
| Primary outcome measure | Eustachian tube score (ear popping during swallowing and blowing the ears) at 1 to 2 week before dilatation and at 1 week, 1 month, 3 months, 6 months 12 months and 24 months after dilatation |
| Secondary outcome measures | 1. Pure tone audiometry 2. Tympanometry Measured at 1 to 2 week before dilatation and at 1 week, 1 month, 3 months, 6 months, 12 months and 24 months after dilatation |
| Overall study start date | 04/01/2012 |
| Overall study end date | 04/01/2015 |
| Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 200 |
| Participant inclusion criteria | Patients with Eustachian tube dysfunction identified in the clinic will be invited to participate |
| Participant exclusion criteria | 1. Children 2. Active nasal disease e.g. polyps, deviated septum |
| Recruitment start date | 04/01/2012 |
| Recruitment end date | 04/01/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
BS10 5NB
United Kingdom
Sponsor information
Hospital/treatment centre
ENT Department
Southmead Hospital
Westbury on Trym
Bristol
BS10 5NB
England
United Kingdom
| Phone | +44 (0)117 950 5050 |
|---|---|
| Adenike.Oluwasanmi@nbt.nhs.co.uk | |
| Website | http://www.nbt.nhs.uk |
"ROR" |
https://ror.org/036x6gt55 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
