Condition category
Ear, Nose and Throat
Date applied
02/12/2011
Date assigned
28/12/2011
Last edited
09/09/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

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

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Adenike Oluwasanmi

ORCID ID

Contact details

ENT Department
Southmead Hospital
Westbury on Trym
Bristol
BS10 5NB
United Kingdom
+44(0)7985 544 850
Adenike.Oluwasanmi@nbt.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effect of Balloon dilatation on Eustachian Tube dysfunction: a randomised controlled 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

Not provided at time of registration

Study design

Randomised controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

04/01/2012

Overall trial end date

04/01/2015

Reason abandoned

Lack of funding/sponsorship

Eligibility

Participant inclusion criteria

Patients with Eustachian tube dysfunction identified in the clinic will be invited to participate

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

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

United Kingdom

Trial participating centre

ENT Department
Bristol
BS10 5NB
United Kingdom

Sponsor information

Organisation

North Bristol NHS Trust (UK)

Sponsor details

ENT Department
Southmead Hospital
Westbury on Trym
Bristol
BS10 5NB
United Kingdom
+44 (0)117 950 5050
Adenike.Oluwasanmi@nbt.nhs.co.uk

Sponsor type

Hospital/treatment centre

Website

http://www.nbt.nhs.uk

Funders

Funder type

Hospital/treatment centre

Funder name

North Bristol NHS trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes