Clinical trial · Interventional
A Prospective, Randomized, Controlled Clinical Study of BET Combined With Tympanostomy Tube Insertion in the Treatment of Intractable OME After Radiotherapy for NPC
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Otitis Media With Effusion After Nasopharyngeal Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Balloon Eustachian Tuboplasty with Tympanostomy Tube Insertion | Procedure | — | UNRESOLVED |
| Tympanostomy Tube Insertion | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Balloon Eustachian Tuboplasty with Tympanostomy Tube Insertion
- interventionNames
- Procedure: Balloon Eustachian Tuboplasty with Tympanostomy Tube Insertion
- type
- OTHER
- label
- Tympanostomy Tube Insertion
- interventionNames
- Procedure: Tympanostomy Tube Insertion
Primary outcomes (1)
- measure
- changes in air pressure (Tympanogram)
- timeFrame
- collected at 1 month, 3 months, 6 months and 12 months after the ventilation tube removal
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * 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
References
Publications (0)
Data not yet available