Role of Eustachian tube surgery in the treatment of chronic secretory otitis media
| ISRCTN | ISRCTN38272958 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38272958 |
| Secondary identifying numbers | ChiCTR2100046672 |
- Submission date
- 16/06/2021
- Registration date
- 08/07/2021
- Last edited
- 09/05/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Ear, Nose and Throat
Plain English summary of protocol
Background and study aims
This study treats patients with chronic secretory otitis media (inner ear infection) by the techniques of balloon dilation of the eustachian tube (connect the middle ears to the back of the throat), tympanic (eardrum) tube placement, and a combination of both, and follows up their response and prognosis (eustachian tube function, hearing, and other indicators) to provide a data basis for optimal treatment plans for patients with chronic secretory otitis media in the future.
Who can participate?
Adults aged 18 to 70 years diagnosed with chronic secretory otitis media in China.
What does the study involve?
Patients diagnosed with chronic secretory otitis media were asked to participate in this study when they visit the hospital. Patients were randomly assigned to the balloon dilation of the eustachian tube (BDET), tympanic tube placement (Tube), and a combination of both (BDET+Tube) in a 1:1:1 ratio and received the corresponding surgical treatment. Clinical follow-up at 1 month, 3 months, 6 months, and 12 months after surgery. The study lasts three years in total.
What are the possible benefits and risks of participating?
Patients may receive the same clinical benefit and potentially improved condition as with conventional eustachian balloon dilation or tympanic tube placement or a combination of the two. Potential complications associated with balloon dilation of the eustachian tube or tympanic tube placement may occur during or after the procedure.
Where is the study run from?
The study is being run by the Sixth Medical Center of PLA General Hospital and takes place in 21 hospitals across China.
When is the study starting and how long is it expected to run for?
April 2021 to July 2027
Who is funding the study?
The Sixth Medical Center of PLA General Hospital (China)
Who is the main contact?
Dr. Zhaohui Hou, Houstone301@yahoo.com
Contact information
Scientific
The Sixth Medical Center of PLA General Hospital
No.6, Fucheng Road
Haidian District
Beijing
100037
China
 ORCID ID |
0000-0003-1621-8242 |
|---|---|
| Phone | +86 13810700293 |
| houstone301@yahoo.com |
Study information
| Study design | Multicenter interventional randomized parallel clinical study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Prospective, multicenter, randomized, controlled clinical study to evaluate the effectiveness of Eustachian tube surgical intervention in the treatment of chronic secretory otitis media |
| Study acronym | ETSICSOM |
| Study objectives | Treatment with BDET has the opportunity to allow patients to avoid tympanic tube placement, or the possibility of enhanced outcomes with BDET in conjunction with tympanic tube placement. |
| Ethics approval(s) | Approved 07/05/2021, RB of Chinese PLA General Hospital (No.28, Fuxing Road, Haidian District, Beijing; +86(0)10-66957608; 301jgb@sina.com), ref: HZKY-PJ-2021-15 |
| Health condition(s) or problem(s) studied | Surgical intervention of chronic secretory otitis media |
| Intervention | This study treats patients with chronic secretory otitis media by balloon dilation of the Eustachian tube (BDET), tympanic tube placement (Tube), and a combination of both (BDET+Tube). Block randomization method was adopted, and independent biostatisticians were responsible for generating random codes. According to the results of random grouping, researchers provided corresponding treatment for patients. Subjects were randomly assigned to the BDET group, the BDET+TUBE group, or the TUBE group in a ratio of 1:1:1. BDET group: The patients were treated with eustachian tube balloon dilatation surgery. Follow-up at 1 month, 3 months, 6 months, and 1 year after surgery. Tube group: The patients were treated with tympanic tube placement surgery. Follow-up at 1 month, 3 months, 6 months, and 1 year after surgery. BDET+Tube group: The patients were treated with eustachian tube balloon dilatation surgery combined with tympanic tube placement surgery. Follow-up at 1 month, 3 months, 6 months, and 1 year after surgery. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Eustachian tube dysfunction, measured using the eustachian tube score (ETS) at baseline and 12 months after the operation |
| Secondary outcome measures | 1. Eustachian tube patency measured using recovery rate of Valsalva test at 3, 6 months 2. Hearing measured using pure tone audiometry at 6, 12 months 3. Morphology of tympanic membrane measured using otoendoscopy at 3, 6 months 4. Clearance of middle ear effusion measured using otoendoscopy at 1, 3 months 5. Eustachian tube dysfunction, measured using the ETS score 3, 6 months |
| Overall study start date | 01/04/2021 |
| Completion date | 01/07/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 480 |
| Key inclusion criteria | 1. Age 18 to 70 years (including borderline values), with no restriction on gender 2. Patients diagnosed with chronic secretory otitis media, with no restriction on side, and those who meet the criteria in both ears can be included. 3. History of chronic secretory otitis media greater than 3 months. 4. Complete tympanic membrane with clear middle ear effusion on otoscopic examination. 5. Conductive deafness. 6. Acoustic conduction resistance with type B or C curve. 7. Negative for Valsalva. 8. History of previous tympanic membrane puncture or medication (nasal spray hormone and/or mucus promoter, etc.). 9. Patients who are to be treated with tympanic tube placement or eustachian tube balloon dilation for the first time and meet the indications for the surgery. |
| Key exclusion criteria | 1. Fluctuating sensorineural deafness. 2. Otoscopic examination of the tympanic membrane with adhesions to the tympanic capsule or the presence of otitis externa (oozing from the external ear canal, fungal infection, etc.) 3. Clear presence of abnormal opening of the eustachian tube or other eustachian tube diseases. 4. Eligible for surgical treatment due to other nasal, sinus or ear diseases. 5. History of surgery on the affected middle ear and nasal cavity or nasopharynx. 6. History of cleft palate or other deformities or related surgical repair. 7. History of head or neck surgery or radiation therapy 8. Patients with ciliary immobility syndrome. 9. Expected survival for malignancy <12 months. 10. Patients with other conditions that, in the opinion of the investigator, are not suitable for participation in this study. |
| Date of first enrolment | 15/06/2021 |
| Date of final enrolment | 31/12/2026 |
Locations
Countries of recruitment
- China
Study participating centres
100037
China
200031
China
510120
China
610031
China
450052
China
518036
China
250012
China
330006
China
400016
China
410008
China
430060
China
710038
China
230022
China
100034
China
528000
China
110004
China
264001
China
100191
China
100730
China
518172
China
528300
China
510000
China
570100
China
450000
China
Sponsor information
Hospital/treatment centre
No. 6 Fucheng Road
Haidian District
Beijing
100037
China
| Phone | +86 (0)1066957608 |
|---|---|
| nghospital@sina.com |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/07/2027 |
|---|---|
| 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. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Editorial Notes
09/05/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2022 to 31/12/2026.
2. The overall end date was changed from 01/04/2024 to 01/07/2027.
3. The intention to publish date was changed from 31/07/2024 to 31/07/2027.
4. The plain English summary was updated to reflect these changes.
16/08/2022: The Third Affiliated Hospital of Sun Yat-sen University, Haikou People's Hospital and Henan Provincial People's Hospital were added to the trial participating centres.
05/07/2021: Trial's existence confirmed by the Sixth Medical Center of PLA General Hospital.
