Distribution of Bacteria in OME After Radiotherapy For NPC.

Active, not recruiting

• Conditions: Otitis Media Effusion; Nasopharyngeal Carcinoma

• Registration Number: NCT06523933
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary

To observe the prognostic difference of tympanocentesis in different kinds of otitis media effusion.

Detailed Description

This study is a prospective, observational clinical study to observe the difference in prognosis of tympanocentesis in different kinds of otitis media effusion (OME), especially OME after radiotherapy for nasopharyngeal carcinoma (NPC). A total of 234 patients diagnosed with OME who are given the treatment of tympanocentesis only, including outpatient and inpatient patients, were included in the study. The middle ear effusion collected during the tympanocentesis is sent for bacterial culture. The positive rate of the effusion and the recurrence rate within 24 weeks will be compared in order to figure out whether bacterial infection is an important influencing factor for some kinds of OME in addition to eustachian tube dysfunction, which is acknowledged.

Study Timeline

• Study Start: 2024-05-12
• Status Verified: 2024-07
• Study First Submitted: 2024-07-10
• Study First Submitted QC: 2024-07-23
• Last Update Submitted: 2024-07-23
• Study First Posted: 2024-07-26
• Last Update Posted: 2024-07-26
• Primary Completion: 2024-11-12
• Study Completion: 2025-05-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 234

Inclusion Criteria

• patients clinical diagnosis of OME or OME after radiotherapy for NPC (Diagnostic criteria: fluid visible in the middle ear and a type B tympanogram).
• patients volunteered to participate in the study and signed the informed consent

Exclusion Criteria

• NPC recurrence or other malignant tumor after radiotherapy.
• clear diagnosis of Eustachian ostium atresia or nasal obstruction diseases, such as severe deviated nasal septum, choanal atresia, osteoradionecrosis of skull base after radiotherapy, etc.
• pregnant and lactating women.
• patients with severe underlying diseases or with severe liver and kidney dysfunction.
• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Positive Bacterial Culture Rate in Middle Ear Effusion	Up to 24 weeks

Secondary Outcome Measures

Name	Time	Method
Eustachian Tube Dysfunction Questionnaire (ETDQ-7)	Collected at 6, 12, 24 Weeks after Tympanocentesis	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.
Changes in Air Pressure (Tympanogram)	Collected at 6, 12, 24 Weeks after Tympanocentesis	Tympanogram changed from type B to type A or type C.

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China