Distribution of Bacteria in OME After Radiotherapy For NPC.

Distribution of Bacteria in Otitis Media With Effusion After Radiotherapy For Nasopharyngeal Carcinoma.

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

Study Overview

• Status: Active, not recruiting
• Conditions: Nasopharyngeal Carcinoma; 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 Type: Observational
• Enrollment (Estimated): 234

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with OME and OME after radiotherapy for NPC, who are given the treatment of tympanostomy only, including outpatient and inpatient patients, were included in the study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
ON+; Patients with OME after NPC with a Positive Result of Bacteria Culture of Middle Ear Effusion.
ON-; Patients with OME after NPC with a Negative Result of Bacteria Culture of Middle Ear Effusion.
O+; Patients with OME with a Positive Result of Bacteria Culture of Middle Ear Effusion.
O-; Patients with OME with a Negative Result of Bacteria Culture of Middle Ear Effusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Positive Bacterial Culture Rate in Middle Ear Effusion	Up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Air Pressure (Tympanogram)	Tympanogram changed from type B to type A or type C.	Collected at 6, 12, 24 Weeks after Tympanocentesis
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.	Collected at 6, 12, 24 Weeks after Tympanocentesis

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Investigators: Principal Investigator: Hao Xiong, Sun Yat-sen Memorial Hospital，Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2024
• Primary Completion (Estimated): November 12, 2024
• Study Completion (Estimated): May 12, 2025

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): July 26, 2024
• Last Update Submitted That Met QC Criteria: July 23, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Bacteria; Nasopharyngeal Carcinoma; Otitis Media Effusion
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Ear Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma; Otitis; Otitis Media; Otitis Media with Effusion
• Other Study ID Numbers: SYSKY-2023-448-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No