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Clinical study on the improvement of eustachian tube function in patients with otitis media with effusion after radiotherapy of nasopharyngeal carcinoma by balloon eustachian tuboplasty combined with eustachian tube inflation

Clinical study on the improvement of eustachian tube function in patients with otitis media with effusion after radiotherapy of nasopharyngeal carcinoma by balloon eustachian tuboplasty combined with eustachian tube inflation

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080621
Enrollment
Unknown
Registered
2024-02-02
Start date
2024-02-02
Completion date
Unknown
Last updated
2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secretory otitis media

Interventions

Control group:Balloon eustachian tuboplasty was performed.
Treatment group:Balloon eustachian tuboplasty combined with eustachian tube inflation.

Sponsors

The Third Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.18-80 years old; 2.The diagnosis was confirmed by pathology as nasopharyngeal carcinoma; 3.Receiving radiation therapy for the first time; 4.Secretory otitis media was confirmed by otoscopy, pure tone threshold audiometry, tympanogram, eustachian tube function examination, etc. 5.Patients who had used any nasal steroid spray for at least 4 consecutive weeks daily or completed at least one course of oral steroid conservative treatment in the 90 days prior to admission, and had failed to respond to repeated tympanocentesis; 6.Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1.History of head and neck surgery during follow-up after enrollment; 2.Active chronic or acute otitis media; 3.Tympanic membrane perforation; 4.Acute upper respiratory tract infection; 5.Active temporomandibular joint disorder; 6.History of cleft palate or cleft palate repair; 7.History of Crouzon syndrome; 8.History of ciliary dyskinesia syndrome; 9.Previous surgical intervention of eustachian tube; 10.Middle ear malformation; 11.Hearing loss before radiotherapy; 12.Failure to return to the hospital for follow-up visits according to the research plan; 13.Other reasons deemed unsuitable for inclusion by the researchers.

Design outcomes

Primary

MeasureTime frame
ETS score;

Secondary

MeasureTime frame
ETDQ-7 score;Tympanogram;Pure tone threshold audiometry;TheChineseversionoftheChronicEar Survey;

Countries

China

Contacts

Public ContactPeng Li

The Third Affiliated Hospital of Sun Yat-sen University

lp76@163.net+86 137 1066 5889

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026