Tympanostomy Tubes Versus Eustachian Tube Dilation
Status: | Not yet recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/24/2019 |
Start Date: | May 2019 |
End Date: | August 2021 |
Contact: | Jessica Campbell |
Email: | jc4353@cumc.columbia.edu |
Phone: | 212-305-2298 |
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.
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.
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)
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)
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
We found this trial at
1
site
New York, New York 10027
Principal Investigator: Ana Kim, MD
Phone: 212-305-2298
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