Clinical trial NCT03886740: Tympanostomy Tubes Versus Eustachian Tube Dilation
Official title: Tympanostomy Tubes Versus Eustachian Tube Dilation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Eustachian Tube Dysfunction
Eustachian Tube Dysfunction of Left Ear
Eustachian Tube Dysfunction of Right Ear (Diagnosis)
Eustachian Tube Dysfunction of Both Ears (Diagnosis)
Keywords: Eustachian Tube Dysfunction
Eustachian Tube balloon dilation
Eustachian Tube dilation
Tympanostomy
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2019-03-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One arm will be treated with tympanostomy with pressure equalization tube placement and the other with Eustachian tube (ET) dilation. Their Eustachian Tube Dysfunction Questionnaire-7 scores will be collected over time and compared.
Primary purpose: OTHER

Brief summary: The objective of this study is to determine whether tympanostomy with pressure equalization tube placement or Eustachian tube (ET) dilation is superior at reducing symptoms of patients with ET dysfunction.

Given the apparent promise of Eustachian tube dilation and the lack of head to head comparison to the more traditional tympanostomy tube, this study seeks to compare them in a head to head manner in order to assess superiority in regards to ETDQ-7 and tympanogram improvements.

Detailed description: The eustachian tube serves to ventilate and equalize middle ear pressure; clear secretions from the middle ear with mucociliary action; and protect the middle ear from sounds, pathogens, and secretions from the nasopharynx. First described anatomically by Eustachius in 1563 and with its exact function worked out a century later, Valsalva realized in 1703 that its opening was dynamic, not static, and described the namesake maneuver to expel pus from the middle ear into the external auditory canal. By the mid 18th century, multiple authors had attempted Eustachian tube catheterization and by the early 19th century, catheterization with irrigation and air insufflation had been described.(1) This shows how Eustachian tube dilation has been a known treatment for centuries, despite its relative obscurity prior to this decade. ET dysfunction is a common diagnosis many patients receiving care from an otologist or otolaryngologist receive. Dysfunction can be broken down into dilatory, which is caused by inflammation such as a virus, baro-challenge induced such as in scuba divers or those taking flights and patulous, which is of unclear etiology.(2) Symptoms are thought to include but are not limited to ear fullness, the sensation that the ear is underwater, otalgia, muffled hearing, tinnitus, autophony and ear popping amongst others. Clear diagnostic criteria are not present, though it is generally felt that a combination of symptoms and objective findings on otoscopy or tympanogram are enough to support the diagnosis. Many have resorted to using the Eustachian Tube Dysfunction Questionnaire-7 which is a validated symptom driven assessment, although it is only moderately associated with objective measures of ET dysfunction. (3,4) The only population-based study looking at prevalence used otoscopy, tympanogram and audiometry to estimate that it affects 0.9% of adults.(5) Unfortunately, there is currently no gold standard for treatment of ET dysfunction.

The only randomized control study of medical treatments showed no impact of nasal steroids on ET dysfunction.(6) The most common surgical option is a tympanostomy tube, which has been used since the 1950s for both middle ear effusions and ET dysfunction.(7) Tympanostomy tubes can alleviate tympanic membrane retraction, atelectasis and effusion, although they do not address the underlying etiology of the ET dysfunction. Numerous nonrandomized and or noncontrolled studies have showed improvement in symptoms with tympanostomy tube placement. Depending on the study and the definition, 70-100% improvement has been reported. Despite this, high-level evidence for tympanostomy tube efficacy in ET dysfunction remains lacking.(8) Adenoidectomy has also been proposed as a way to improve ET function, but not surprisingly, most studies have shown that it only helps if the adenoids are found to be abutting or obstructing the torus tubarii.(9,10) Furthermore, these studies focus on children, and the adenoid pad is not likely to be a contributing factor in most adults. Eustachian tube balloon dilation recently came back into the mainstream beginning with the 2010 study by Ockermann et al. which showed the procedure was safe and produced good results in a small cohort. Numerous studies since then have shown efficacy, including two separate multicenter randomized controlled trials published in 2017 and 2018. Both of these showed statistically and clinically significant superiority of ET balloon dilation over control as measured by improvement in ETDQ-7 and tympanogram type at up to 1 year. (11,12,13)

Eligibility criteria: Inclusion Criteria:

Determined to have chronic Eustachian tube dysfunction of at least 3 month duration based on a score of ≥ 14.5 on the Eustachian tube dysfunction questionnaire-7 (ETDQ-7), regardless of tympanogram status

Exclusion Criteria:

* Insurance that does reimburse for ET balloon dilation
* Patients with acute upper respiratory infection
* Tympanic membrane perforation
* Known middle ear disease such as cholesteatoma, acute otitits media, history of head and neck radiation, history of cleft palate, cystic fibrosis, ciliary dyskinesia, nasopharyngeal mass and patulous eustachian tube

Primary outcomes:
measure: ETDQ-7 score
timeFrame: Baseline
measure: ETDQ-7 score
timeFrame: 6-weeks
measure: ETDQ-7 score
timeFrame: 3-months
measure: ETDQ-7 score
timeFrame: 6-months
measure: ETDQ-7 score
timeFrame: 1-year
measure: Tympanogram
timeFrame: Baseline
measure: Tympanogram
timeFrame: 6-weeks
measure: Tympanogram
timeFrame: 3-months
measure: Tympanogram
timeFrame: 6-months
measure: Tympanogram
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Columbia University
name: Ana Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Feldmann H. [The Eustachian tube and its role in the history of otology. Images from the history of otorhinolaryngology, presented by instruments from the collection of the Ingolstadt German History Museum]. Laryngorhinootologie. 1996 Dec;75(12):783-92. doi: 10.1055/s-2007-997676. German.
citation: Schilder AG, Bhutta MF, Butler CC, Holy C, Levine LH, Kvaerner KJ, Norman G, Pennings RJ, Poe D, Silvola JT, Sudhoff H, Lund VJ. Eustachian tube dysfunction: consensus statement on definition, types, clinical presentation and diagnosis. Clin Otolaryngol. 2015 Oct;40(5):407-11. doi: 10.1111/coa.12475. No abstract available.
citation: McCoul ED, Anand VK, Christos PJ. Validating the clinical assessment of eustachian tube dysfunction: The Eustachian Tube Dysfunction Questionnaire (ETDQ-7). Laryngoscope. 2012 May;122(5):1137-41. doi: 10.1002/lary.23223. Epub 2012 Feb 28.
citation: Teixeira MS, Swarts JD, Alper CM. Accuracy of the ETDQ-7 for Identifying Persons with Eustachian Tube Dysfunction. Otolaryngol Head Neck Surg. 2018 Jan;158(1):83-89. doi: 10.1177/0194599817731729. Epub 2017 Sep 26.
citation: Browning GG, Gatehouse S. The prevalence of middle ear disease in the adult British population. Clin Otolaryngol Allied Sci. 1992 Aug;17(4):317-21. doi: 10.1111/j.1365-2273.1992.tb01004.x.
citation: Gluth MB, McDonald DR, Weaver AL, Bauch CD, Beatty CW, Orvidas LJ. Management of eustachian tube dysfunction with nasal steroid spray: a prospective, randomized, placebo-controlled trial. Arch Otolaryngol Head Neck Surg. 2011 May;137(5):449-55. doi: 10.1001/archoto.2011.56.
citation: Pappas JJ. Middle ear ventilation tubes. Laryngoscope. 1974 Jul;84(7):1098-117. doi: 10.1288/00005537-197407000-00004. No abstract available.
citation: Llewellyn A, Norman G, Harden M, Coatesworth A, Kimberling D, Schilder A, McDaid C. Interventions for adult Eustachian tube dysfunction: a systematic review. Health Technol Assess. 2014 Jul;18(46):1-180, v-vi. doi: 10.3310/hta18460.
citation: Nguyen LH, Manoukian JJ, Yoskovitch A, Al-Sebeih KH. Adenoidectomy: selection criteria for surgical cases of otitis media. Laryngoscope. 2004 May;114(5):863-6. doi: 10.1097/00005537-200405000-00014.
citation: Bluestone CD, Cantekin EI, Beery QC. Certain effects of adenoidectomy of Eustachian tube ventilatory function. Laryngoscope. 1975 Jan;85(1):113-27. doi: 10.1288/00005537-197501000-00009.
citation: Poe D, Anand V, Dean M, Roberts WH, Stolovitzky JP, Hoffmann K, Nachlas NE, Light JP, Widick MH, Sugrue JP, Elliott CL, Rosenberg SI, Guillory P, Brown N, Syms CA 3rd, Hilton CW, McElveen JT Jr, Singh A, Weiss RL Jr, Arriaga MA, Leopold JP. Balloon dilation of the eustachian tube for dilatory dysfunction: A randomized controlled trial. Laryngoscope. 2018 May;128(5):1200-1206. doi: 10.1002/lary.26827. Epub 2017 Sep 20.
citation: Meyer TA, O'Malley EM, Schlosser RJ, Soler ZM, Cai J, Hoy MJ, Slater PW, Cutler JL, Simpson RJ, Clark MJ, Rizk HG, McRackan TR, D'Esposito CF, Nguyen SA. A Randomized Controlled Trial of Balloon Dilation as a Treatment for Persistent Eustachian Tube Dysfunction With 1-Year Follow-Up. Otol Neurotol. 2018 Aug;39(7):894-902. doi: 10.1097/MAO.0000000000001853.
citation: Anand V, Poe D, Dean M, Roberts W, Stolovitzky P, Hoffmann K, Nachlas N, Light J, Widick M, Sugrue J, Elliott CL, Rosenberg S, Guillory P, Brown N, Syms C, Hilton C, McElveen J, Singh A, Weiss R, Arriaga M, Leopold J. Balloon Dilation of the Eustachian Tube: 12-Month Follow-up of the Randomized Controlled Trial Treatment Group. Otolaryngol Head Neck Surg. 2019 Apr;160(4):687-694. doi: 10.1177/0194599818821938. Epub 2019 Jan 8.