Balloon tuboplasty for eustachian tube dysfunction after radiotherapy
Research type
Research Study
Full title
Balloon tuboplasty for eustachian tube dysfunction after radiotherapy
IRAS ID
261072
Contact name
Arvind Arya
Contact email
Sponsor organisation
BCUHB
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Individuals diagnosed with head and neck cancer often receive treatment in the form of radiotherapy, either on its own or in combination with chemotherapy and/or surgery. Radiotherapy targets the DNA within cells undergoing rapid division (i.e. cancer cells) and causes damage which leads to cell death. It can never be 100% targeted on cancer cells and the surrounding normal tissues are subjected to the same stimulus. Nearby tissues which are also undergoing divison and are exposed to radiation can also be damaged which results in inflammation, scarring and loss of normal function.
The eustachian canal is a tube connecting the middle ear to the nose. Its role is to facilitate air pressure equalisation between the outside world and the middle ear, which helps the ear to function optimally. Dysfunction of this tube is common in children due to anatomical differences which tend to resolve as the skull matures. Whilst dysfunctional, the eustachian canal is less able to facilitate this equalisation process which can lead to negative ear pressures which draw fluid into the usually aerated space. This fluid can be problematic and once it becomes very thick it can disrupt hearing, whilst also causing ear discomfort and provoking infections.
Radiation exposure to areas near the eustachian canal can cause eustachian tube dysfunction. This includes radiotherapy targeted at cancers in the post-nasal space, the upper neck and the parotid salivary gland. Our pilot study aims to target the eustachian canal in these types of patients and restore its function using an approved surgical balloon device already in circulation which can be inflated in the canal and stretch the post-radiotherapy scar tissue. We hope that by stretching the scar tissue, a long lasting effect will be achieved.
REC name
Wales REC 5
REC reference
20/WA/0013
Date of REC Opinion
22 Jan 2020
REC opinion
Unfavourable Opinion