Condition category
Ear, Nose and Throat
Date applied
21/11/2017
Date assigned
23/11/2017
Last edited
23/11/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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tuboplasty (BET) is a potential treatment option where a balloon is inserted into the Eustachian tube, inflated, then withdrawn.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 December 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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Saku Sinkkonen

ORCID ID

http://orcid.org/0000-0002-6601-4216

Contact details

Kasarmikatu 11-13
Helsinki
00029
Finland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

§97/2017

Study information

Scientific title

Efficacy of balloon Eustachian tuboplasty - prospective, blinded and placebo-controlled multi-centre study

Acronym

EBET

Study hypothesis

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

Tampere University Hospital Ethics Committee, 02/05/2017, ref: R17040

Study design

Prospective blinded placebo-controlled multi-centre 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 to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

26/01/2017

Overall trial end date

31/12/2022

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

165 (55 patients in each indication group)

Participant 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

Recruitment start date

27/11/2017

Recruitment end date

31/12/2020

Locations

Countries of recruitment

Finland

Trial participating centre

Helsinki University Hospital
Surgical Hospital, Kasarmikatu 11-13
Helsinki
00029
Finland

Trial participating centre

Turku University Central Hospital
Kiinamyllynkatu 4–8
Turku
20521
Finland

Trial participating centre

Tampere University Hospital
Teiskontie 35
Tampere
33521
Finland

Sponsor information

Organisation

Helsinki University Hospital

Sponsor details

Kasarmikatu 11-13
Helsinki
00029
Finland

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

State funding for University level health research

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Research Foundation for ENT Disorders

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

31/12/2023

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes