NCT05449184

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 208 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 15 Years – 70 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Otitis Media With Effusion After Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Balloon Eustachian Tuboplasty with Tympanostomy Tube Insertion	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.
PROCEDURE	Tympanostomy Tube Insertion	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.

Timeline

• Start date: 2022-06-14
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2022-07-08
• Last updated: 2022-07-08

Locations

1 site across 1 country: China