Otitis Media With Effusion After Nasopharyngeal CarcinomaNCT05449184
A Prospective, Randomized, Controlled Clinical Study of BET Combined With Tympanostomy Tube Insertion in the Treatment of Intractable OME After Radiotherapy for NPC
A study testing Balloon Eustachian Tuboplasty with Tympanostomy Tube Insertion and Tympanostomy Tube Insertion in people with Otitis Media With Effusion After Nasopharyngeal Carcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
The primary purpose of this study is to compare balloon Eustachian tuboplasty (BET) combined with tympanostomy tube insertion and simply tympanostomy tube insertion in the treatment of otitis media with effusion (OME) in post-radiotherapy patients on the improvement of subjective symptoms (ear fullness, etc.) and the… Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Otitis Media With Effusion After Nasopharyngeal Carcinoma
- What is being tested?
- Balloon Eustachian Tuboplasty with Tympanostomy Tube Insertion and Tympanostomy Tube Insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteChina
- Study dates
- 14 Jun 2022to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients clinically diagnosed OME after radiotherapy for NPC (diagnostic criteria: have fluid drained from tympanic cavity during tympanocentesis) , who had completed radiotherapy for ≥6 months, and had failed to respond after two or more times of tympanocentesis
- Eustachian Tube Dysfunction Questionnaire score greater than 14
- clinical findings of a retracted drum
- fluid behind the drum
- tympanometry type B or C results
- patients volunteered to participate in the study and signed the informed consent
- patients volunteered to bear the corresponding costs of surgery and consumables.
Who cannot join
- NPC recurrence or other malignant tumor after radiotherapy
- a perforated tympanic membrane
- the presence of a ventilation tube
- a period of less than six months following the final radiotherapy treatment
- clear diagnosis of Eustachian ostium atresia or nasal obstruction diseases, such as severe deviated nasal septum, nasal polyp, choanal atresia, osteoradionecrosis of skull base after radiotherapy, etc.
- patients with severe underlying diseases could not tolerate general anesthesia
Show all 10Show fewer
- patients who could not cooperate (including poor hearing and radiation encephalopathy)
- patients with other middle ear diseases, such as middle ear cholesteatoma, osteoradionecrosis of temporal bone after radiotherapy, etc.
- severe deglutition disorders
- cleft palate
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, 广东 (Guǎngdōng), 510120
Hao Xiong, +8613725130384, xiongh7@mail.sysu.edu.cn
About this study
Official title: A Prospective, Randomized, Controlled Clinical Study of Balloon Eustachian Tuboplasty Combined With Tympanostomy Tube Insertion in the Treatment of Intractable Otitis Media With Effusion After Radiotherapy for Nasopharyngeal Carcinoma
The primary purpose of this study is to compare balloon Eustachian tuboplasty (BET) combined with tympanostomy tube insertion and simply tympanostomy tube insertion in the treatment of otitis media with effusion (OME) in post-radiotherapy patients on the improvement of subjective symptoms (ear fullness, etc.) and the tympanogram.
The secondary purpose is to clarify the effects of BET on the incidence of middle ear infection and slippage of ventilation tube during tube retention, as well as to determine the difference of hearing improvement between the two management methods.
Read the detailed description
Nasopharyngeal carcinoma (NPC) is the most common malignancy of the nasopharynx, of which Guangdong Province is the high-risk area. At present, the comprehensive treatment plan based on radiotherapy (RT) makes NPC a good prognosis, so it is the complications of RT that have become the main factor affecting the life quality of patients. Otitis media with effusion (OME) following RT is the most common ear complication, which is characterized by a large amount of effusion from the tympanic cavity (the cavity of middle ear).
Ear fullness and hearing loss could take place because of tympanic effusions, reducing the patient's ability to communicate and increasing life risk. Currently Eustachian tube dysfunction (ETD) due to RT is regarded as an important causative factor.
The Eustachian tube, connecting the middle ear to the outside world, is an important ventilation pipe. RT could lead to hyperemia, edema, and then fibrosis and atrophy of the Eustachian tube mucosa, resulting in organic changes of the Eustachian tube, including stiffness, adhesions, narrowing and even atresia, and eventually the formation of OME.
Comparatively, non-radiation-related OME is usually a nonorganic disease, which is the biggest pathogenic difference between the two. However, treatment of OME following RT is still the same as that of non-radiation-related one, but the clinical efficacy is much worse than the latter. Conservative treatments such as physical and pharmacological therapy usually turn out to be ineffective. The most widely used ones are tympanocentesis and tympanostomy tube insertion. Tympanocentesis is to directly pierce the tympanic membrane and drain the middle ear effusion. However, the drainage port usually heals within 3-5 days, so it is often necessary to pierce repeatedly. The ventilation tube insertion is considered to achieve continuous drainage, but the risks of middle ear infection, slippage of ventilation tube, and permanent tympanic membrane perforation is high after the placement of tube. Therefore, the residence time of the ventilation tube is generally no more than 6-9 months.
At present, the treatments of OME following RT just deal with symptoms, instead of the cause--ETD, resulting in low cure rate, high recurrence rate and high complication rate. In recent years, balloon Eustachian tuboplasty (BET) has been performed successfully with encouraging results in patients with ETD by dilating (make larger) the cartilage segment of the Eustachian tube. However, ETD following RT used to be recognized as a contraindication to BET, possibly due to more complex pathogenesis, scruples for damage to the internal carotid artery in the lateral of the Eustachian tube, and Eustachian tube atresia. The above reasons are only speculation, and there have been already a few reports of BET being used in OME after RT for head and neck tumors.
The primary purpose of this study is to compare BET combined with tympanostomy tube insertion and simply tympanostomy tube insertion in the treatment of OME in post-radiotherapy patients on the improvement of subjective symptoms (ear fullness, etc.) and the tympanogram. The secondary purpose is to clarify the effects of BET on the incidence of middle ear infection and slippage of ventilation tube during tube retention, as well as to determine the difference of hearing improvement between the two management methods.
- Being tested
- Balloon Eustachian Tuboplasty with Tympanostomy Tube Insertion, Tympanostomy Tube Insertion
- Keywords
- Balloon Eustachian Tuboplasty, Tympanostomy Tube Insertion, Otitis Media With Effusion, Nasopharyngeal Carcinoma
- Medical subject headings
- Otitis Media with Effusion, Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon Eustachian Tuboplasty with Tympanostomy Tube InsertionProcedure or surgery
Under local or general anesthesia, insert a balloon into one Eaustachian tube and inflate it for up to two minutes. The balloon is then removed. Subsequently, pierce the tympanic membrane in the front and lower quadrants, suck the tympanic effusion, and then insert a tympanic ventilation tube. The tube will be removed 6 months later.
Tympanostomy Tube InsertionProcedure or surgery
Under local or general anesthesia, pierce the tympanic membrane in the front and lower quadrants, suck the tympanic effusion, and then insert a tympanic ventilation tube. The tube will be removed 6 months later.
| Study group | Role | What they receive |
|---|---|---|
| Balloon Eustachian Tuboplasty with Tympanostomy Tube Insertion | Experimental | Not described Receives: Procedure: Balloon Eustachian Tuboplasty with Tympanostomy Tube Insertion |
| Tympanostomy Tube Insertion | Other | Not described Receives: Procedure: Tympanostomy Tube Insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in air pressure (Tympanogram)
Tympanogram, which measures the movement of the tympanic membrane in response to changes in air pressure, is classified by types - Type A, B and C. Each classification indicates a range that falls between normal and abnormal.
Measured: collected at 1 month, 3 months, 6 months and 12 months after the ventilation tube removal
Secondary outcomes (4)
Incidence of Otitis Media
The number of days of ear discharges or otorrhoea in a 6-month period of tube retention
Measured: 6 months post-operatively during tube retention
Incidence of Slippage of Ventilation Tube
The number of times the ventilation tube falls off in a 6-month period of tube retention
Measured: 6 months post-operatively during tube retention
Eustachian Tube Dysfunction Questionnaire (ETDQ-7)
The ETDQ-7 tool is used to assess the symptoms of Otitis Media With Effusion (OME), which consists of seven items with a scale of graduated responses ranging from 1 (No Problem) to 7 (Severe Problem), and 4 would correspond to a Moderate Problem. If the total score is more than 14, it is considered that there is eustachian tube dysfunction. The average post-operative ETDQ-7 score is less than 2.1 or decrease > 0.5 (minimal clinically important difference=0.5), it is considered that the eustachian tube function is improved.
Measured: collected at 1 month, 3 months, 6 months and 12 months after the ventilation tube removal
Hearing gap
It is the change of air-bone conduction difference between pre-operation and post-operation, which is measured by Pure-Tone Audiometry.
Measured: collected at 1 month, 3 months, 6 months and 12 months after the ventilation tube removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start14 Jun 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis Media With Effusion After Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hao Xiong, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449184
- Sponsor's protocol ID
- 2020-KY-123
- Status last verified
- May 2022
- First submitted
- 1 Jun 2022
- Last updated
- 8 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Clinical Study of Balloon Eustachian Tuboplasty Combined With Tympanostomy Tube Insertion in the Treatment of Intractable Otitis Media With Effusion After Radiotherapy for Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT05449184
- Acronym / sponsor ID
- 2020-KY-123
- Keywords
- Balloon Eustachian Tuboplasty, Tympanostomy Tube Insertion, Otitis Media With Effusion, Nasopharyngeal Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 8 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to compare balloon Eustachian tuboplasty (BET) combined with tympanostomy tube insertion and simply tympanostomy tube insertion in the treatment of otitis media with effusion (OME) in post-radiotherapy patients on the improvement of subjective symptoms (ear fullness, etc.) and the tympanogram.
The secondary purpose is to clarify the effects of BET on the incidence of middle ear infection and slippage of ventilation tube during tube retention, as well as to determine the difference of hearing improvement between the two management methods.
Detailed description
Nasopharyngeal carcinoma (NPC) is the most common malignancy of the nasopharynx, of which Guangdong Province is the high-risk area. At present, the comprehensive treatment plan based on radiotherapy (RT) makes NPC a good prognosis, so it is the complications of RT that have become the main factor affecting the life quality of patients. Otitis media with effusion (OME) following RT is the most common ear complication, which is characterized by a large amount of effusion from the tympanic cavity (the cavity of middle ear).
Ear fullness and hearing loss could take place because of tympanic effusions, reducing the patient's ability to communicate and increasing life risk. Currently Eustachian tube dysfunction (ETD) due to RT is regarded as an important causative factor.
The Eustachian tube, connecting the middle ear to the outside world, is an important ventilation pipe. RT could lead to hyperemia, edema, and then fibrosis and atrophy of the Eustachian tube mucosa, resulting in organic changes of the Eustachian tube, including stiffness, adhesions, narrowing and even atresia, and eventually the formation of OME.
Comparatively, non-radiation-related OME is usually a nonorganic disease, which is the biggest pathogenic difference between the two. However, treatment of OME following RT is still the same as that of non-radiation-related one, but the clinical efficacy is much worse than the latter. Conservative treatments such as physical and pharmacological therapy usually turn out to be ineffective. The most widely used ones are tympanocentesis and tympanostomy tube insertion. Tympanocentesis is to directly pierce the tympanic membrane and drain the middle ear effusion. However, the drainage port usually heals within 3-5 days, so it is often necessary to pierce repeatedly. The ventilation tube insertion is considered to achieve continuous drainage, but the risks of middle ear infection, slippage of ventilation tube, and permanent tympanic membrane perforation is high after the placement of tube. Therefore, the residence time of the ventilation tube is generally no more than 6-9 months.
At present, the treatments of OME following RT just deal with symptoms, instead of the cause--ETD, resulting in low cure rate, high recurrence rate and high complication rate. In recent years, balloon Eustachian tuboplasty (BET) has been performed successfully with encouraging results in patients with ETD by dilating (make larger) the cartilage segment of the Eustachian tube. However, ETD following RT used to be recognized as a contraindication to BET, possibly due to more complex pathogenesis, scruples for damage to the internal carotid artery in the lateral of the Eustachian tube, and Eustachian tube atresia. The above reasons are only speculation, and there have been already a few reports of BET being used in OME after RT for head and neck tumors.
The primary purpose of this study is to compare BET combined with tympanostomy tube insertion and simply tympanostomy tube insertion in the treatment of OME in post-radiotherapy patients on the improvement of subjective symptoms (ear fullness, etc.) and the tympanogram. The secondary purpose is to clarify the effects of BET on the incidence of middle ear infection and slippage of ventilation tube during tube retention, as well as to determine the difference of hearing improvement between the two management methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balloon Eustachian Tuboplasty with Tympanostomy Tube Insertion | Experimental | Procedure: Balloon Eustachian Tuboplasty with Tympanostomy Tube Insertion |
| Tympanostomy Tube Insertion | Other | Procedure: Tympanostomy Tube Insertion |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- patients clinically diagnosed OME after radiotherapy for NPC (diagnostic criteria: have fluid drained from tympanic cavity during tympanocentesis) , who had completed radiotherapy for ≥6 months, and had failed to respond after two or more times of tympanocentesis
- Eustachian Tube Dysfunction Questionnaire score greater than 14
- clinical findings of a retracted drum
- fluid behind the drum
- tympanometry type B or C results
Key exclusion criteria (10 listed)
- NPC recurrence or other malignant tumor after radiotherapy
- a perforated tympanic membrane
- the presence of a ventilation tube
- a period of less than six months following the final radiotherapy treatment
- clear diagnosis of Eustachian ostium atresia or nasal obstruction diseases, such as severe deviated nasal septum, nasal polyp, choanal atresia, osteoradionecrosis of skull base after radiotherapy, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balloon Eustachian Tuboplasty with Tympanostomy Tube InsertionUnder local or general anesthesia, insert a balloon into one Eaustachian tube and inflate it for up to two minutes. The balloon is then removed. Subsequently, pierce the tympanic membrane in the front and lower quadrants, suck the tympanic effusion, and then insert a tympanic ventilation tube. The tube will be removed 6 months later. | Procedure or surgery | Balloon Eustachian Tuboplasty with Tympanostomy Tube Insertion |
| Tympanostomy Tube InsertionUnder local or general anesthesia, pierce the tympanic membrane in the front and lower quadrants, suck the tympanic effusion, and then insert a tympanic ventilation tube. The tube will be removed 6 months later. | Procedure or surgery | Tympanostomy Tube Insertion |
Primary outcome
changes in air pressure (Tympanogram)
Time frame: collected at 1 month, 3 months, 6 months and 12 months after the ventilation tube removal
Tympanogram, which measures the movement of the tympanic membrane in response to changes in air pressure, is classified by types - Type A, B and C. Each classification indicates a range that falls between normal and abnormal.
4 secondary outcomes
Incidence of Otitis Media
Time frame: 6 months post-operatively during tube retention
Incidence of Slippage of Ventilation Tube
Time frame: 6 months post-operatively during tube retention
Eustachian Tube Dysfunction Questionnaire (ETDQ-7)
Time frame: collected at 1 month, 3 months, 6 months and 12 months after the ventilation tube removal
Hearing gap
Time frame: collected at 1 month, 3 months, 6 months and 12 months after the ventilation tube removal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- Individual participant dataSharing planned: Yes
Related trials for Otitis Media With Effusion After Nasopharyngeal Carcinoma
Not yet recruitingPhase 3
Intranasal Corticosteroid Spray for Preventing Otitis Media With Effusion After Radiotherapy in Nasopharyngeal Carcinoma
Otitis Media, Otitis Media With Effusion After Nasopharyngeal Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hao Xiong principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balloon Eustachian Tuboplasty with Tympanostomy Tube Insertion and Tympanostomy Tube Insertion in people with Otitis Media With Effusion After Nasopharyngeal Carcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hao Xiong (+8613725130384, xiongh7@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in air pressure (Tympanogram) (time frame: collected at 1 month, 3 months, 6 months and 12 months after the ventilation tube removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2022.