Efficacy of balloon Eustachian tuboplasty
| ISRCTN | ISRCTN50406162 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50406162 |
| Secondary identifying numbers | §97/2017 |
- Submission date
- 21/11/2017
- Registration date
- 23/11/2017
- Last edited
- 14/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Plain English summary of protocol
Background and study aims
Secretory otitis media is an ear condition where fluid accumulates behind the eardrum and remains there after an ear infection or blockage of the eustachian tube that drains fluid from the ears. Balloon Eustachian tuboplasty (BET) is a potential treatment option where a balloon is inserted into the Eustachian tube, inflated, then withdrawn. About 70-80% of adult patients seem to benefit from BET, at least briefly. Strong evidence of its long-term effectiveness is required. The aim of this study is to assess the effectiveness of BET in patients withlong-term Eustachian tube dysfunction.
Who can participate?
Patients with persistent secretory otitis media or Eustachian tube dysfunction
What does the study involve?
Participants are randomly allocated to be treated with either BET or sham surgery under local anaesthetic. Ear examinations are carried out 3 and 12 months after the operation.
What are the possible benefits and risks of participating?
There may be no direct benefit for the patient but the information revealed from this study will help improve the treatment of people with ETD. There are no known severe risks associated with BET.
Where is the study run from?
1. Helsinki University Hospital (Finland)
2. Tampere University Hospital (Finland)
3. Turku University Central Hospital (Finland)
When is the study starting and how long is it expected to run for?
January 2017 to May 2022
Who is funding the study?
1. State funding for university level health research (Finland)
2. Research Foundation for ENT Disorders (Finland)
Who is the main contact?
Dr Saku Sinkkonen
Contact information
Scientific
Kasarmikatu 11-13
Helsinki
00029
Finland
 ORCID ID |
0000-0002-6601-4216 |
|---|
Study information
| Study design | Prospective blinded placebo-controlled multi-centre 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 to request a patient information sheet |
| Scientific title | Efficacy of balloon Eustachian tuboplasty - prospective, blinded and placebo-controlled multi-centre study |
| Study acronym | EBET |
| Study objectives | Balloon Eustachian tuboplasty (BET) offers benefit to patients with persistent secretory otitis media, severe symptoms of Eustachian tube dysfunction (ETD) or baro-challenged ETD. |
| Ethics approval(s) | Tampere University Hospital Ethics Committee, 02/05/2017, ref: R17040 |
| Health condition(s) or problem(s) studied | Persistent secretory otitis media, severe symptoms of ETD or baro-challenged ETD |
| Intervention | Parallel-group randomisation is made after local anaesthesia induction before the operation. Patients are treated with either BET or sham surgery under local anaesthesia. The patients are blinded to the procedure. Postoperative controls are arranged 3 and 12 months after operation in a blinded manner by a physician not given the treatment. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Measured at baseline, 3 months and 1 year: 1. Valsalva maneuver based on physicians descriptive findings 2. Otomicroscopy based on physicians descriptive findings 3. Tympanometry results classified as A, B and C type outcomes 4. Tubomanometry results based on the Eustachian tube opening and opening latency index 5. Need for grommets |
| Secondary outcome measures | Quality of life measured with disease specific questionnaire ETDQ7 at baseline, 3 months and 1 year |
| Overall study start date | 26/01/2017 |
| Completion date | 31/05/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 165 (55 patients in each indication group) |
| Key inclusion criteria | All patients in this study suffer from dilatory Eustachian tube dysfunction and are deemed suitable for BET. Possible indications are: 1. Persistent secretory otitis media 2. Severe symptoms of ETD 3. Baro-challenged ETD |
| Key exclusion criteria | 1. The occurrence of cleft palate in any form 2. Current ventilating grommet 3. Tympanic membrane perforation 4. Adhesive otitis 5. Cholesteatoma 6. Cystic fibrosis 7. Immotile cilia syndrome 8. Untreated nasal polyposis 9. Samter's triade 10. Untreated gastroesophageal reflux disease 11. Other mechanical obstruction in nasopharynx |
| Date of first enrolment | 27/11/2017 |
| Date of final enrolment | 31/12/2020 |
Locations
Countries of recruitment
- Finland
Study participating centres
Helsinki
00029
Finland
Turku
20521
Finland
Tampere
33521
Finland
Sponsor information
Hospital/treatment centre
Kasarmikatu 11-13
Helsinki
00029
Finland
"ROR" |
https://ror.org/02e8hzf44 |
|---|
Funders
Funder type
Government
No information available
No information available
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. Study protocol, statistical analysis plan, informed consent form, clinical study report and analytic code will be available immediately following publication. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Editorial Notes
14/11/2022: The overall trial end date has been changed from 31/12/2022 to 31/05/2022 and the plain English summary has been updated to reflect this.
