A Prospective, Randomized, Controlled Clinical Study of BET Combined With Tympanostomy Tube Insertion in the Treatment of Intractable OME After Radiotherapy for NPC

NCT05449184 | Unknown

• 1 other identifier: 2020-KY-123
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Otitis Media With Effusion After Nasopharyngeal Carcinoma

Keywords

Balloon Eustachian Tuboplasty; Tympanostomy Tube Insertion; Otitis Media With Effusion; Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• changes in air pressure (Tympanogram)

  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.

  collected at 1 month, 3 months, 6 months and 12 months after the ventilation tube removal

Secondary Outcomes (4)

• Incidence of Otitis Media

  6 months post-operatively during tube retention

• Incidence of Slippage of Ventilation Tube

  6 months post-operatively during tube retention

• Eustachian Tube Dysfunction Questionnaire (ETDQ-7)

  collected at 1 month, 3 months, 6 months and 12 months after the ventilation tube removal

• Hearing gap

  collected at 1 month, 3 months, 6 months and 12 months after the ventilation tube removal

Study Arms (2)

Balloon Eustachian Tuboplasty with Tympanostomy Tube Insertion

EXPERIMENTAL

Procedure: Balloon Eustachian Tuboplasty with Tympanostomy Tube Insertion

Tympanostomy Tube Insertion

OTHER

Procedure: Tympanostomy Tube Insertion

Interventions

Balloon Eustachian Tuboplasty with Tympanostomy Tube Insertion PROCEDURE

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.

Balloon Eustachian Tuboplasty with Tympanostomy Tube Insertion

Tympanostomy Tube Insertion PROCEDURE

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.

Tympanostomy Tube Insertion

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, 广东 (Guǎngdōng), 510120, China

RECRUITING

MeSH Terms

Conditions

Otitis Media with Effusion; Nasopharyngeal Carcinoma

Interventions

Middle Ear Ventilation

Condition Hierarchy (Ancestors)

Otitis Media; Otitis; Ear Diseases; Otorhinolaryngologic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Ostomy; Surgical Procedures, Operative; Otologic Surgical Procedures; Otorhinolaryngologic Surgical Procedures

Study Officials

• Hao Xiong

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Xiong

CONTACT

+8613725130384; xiongh7@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: July 8, 2022
• Study Start: June 14, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: July 8, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)