Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05998356 |
| Other study ID # |
RECHMPL22_0551 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2023 |
| Est. completion date |
January 1, 2027 |
Study information
| Verified date |
September 2023 |
| Source |
University Hospital, Montpellier |
| Contact |
Julia Korchagina, PhD |
| Phone |
+33 4 67 33 61 56 |
| Email |
julia.korchagina[@]chu-montpellier.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
To date, more than 130 000 Balloon Eustachian Tuboplasty (BET) procedures have been performed
worldwide. This procedure is proposed in case of Obstructive Eustachian Tube Dysfunction
(OETD) with or without chronic otitis media. However, the effectiveness of this procedure is
still discussed amongst otolaryngologist. Most of studies,were open label prospective studies
comparing Eustachian tube function before and after surgical treatment. A recent
meta-analysis suggests that BET procedure improves postoperative Eustachian tube function,
but high-level evidence is still lacking. In this project, the investigators propose to
perform the first blinded randomized controlled trial procedure to assess the changes of
Eustachian tube function after BET in a population of subjects with chronic OETD with or
without chronic otitis. Prognosis factors of efficacy will be also investigated during the
study.
Description:
Obstructive Eustachian Tube Dysfunction (OETD) is a common medical condition whose prevalence
is estimated to be 4.6% in the general population. Subjects suffering from OETD display
various symptoms such as ear fullness, hearing loss, muffled hearing, pain, especially during
pressure changes (airplane, diving, mountain experience…), tinnitus, ticking or popping
sounds, autophony, or balance disorders. Failure to treat OETD can lead to chronic otitis
media with cholesteatoma which is a severe medical condition requiring multiple surgeries and
frequently associated with a permanent hearing loss and several major complications including
meningitis, facial palsy and labyrinthitis. OETD medical management (pressure equalization
device, in addition to medical treatment of rhinosinusitis and GERD) can be used in adults.
However, high level evidence of effectiveness of such a treatment is still lacking and the
success rates are unknown.
Surgical treatment such as grommets (tympanostomy tube) is only a temporary solution that
might work in children, but is less effective in adults, requiring multiple surgeries during
the patients lifetime for their repeated. Grommets are treating only the consequences but not
the cause of OETD.
In 2010, the team of Prof. Sudhoff in Bielefeld, Germany, proposed for the first time the
Balloon Dilatation of the Eustachian tube as an alternative treatment of OETD. To date, more
than 75 000 Balloon Eustachian Tuboplasty (BET) procedures have been performed worldwide.
However, the effectiveness of this procedure is still discussed amongst ENT physicians.
Indeed, no blinded controlled randomized clinical trial was performed to address the effects
of BET on Eustachian tube function. Only one randomized clinical trial using objective
measures as outcomes was published so far and compared the effect of BET in addition to
medical management versus medical management alone in an open label study. Knowing that the
success rates of medical management are not clearly established and probably depend on the
medical treatment used, the effect of the surgical procedure remains uncertain with this
design of study. Another randomized controlled study used a quality-of-life questionnaire as
main outcome measure 6 weeks after surgery. No objective assessment was performed as major
outcome and follow-up was not sufficient for the main outcome measure. Most of published
studies so far were open label prospective studies comparing Eustachian tube function before
and after surgical treatment.
In this project, the investigators propose to perform the first blinded randomized controlled
trial versus control procedure to assess the changes of Eustachian tube function after BET in
a population of subjects with chronic OETD with or without chronic otitis, and after medical
treatment failure. Prognosis factors of efficacy will be also investigated during the study.
The control procedure will consist in the insertion of an Eustachian tube catheter, causing
no dilation of the Eustachian tube. This procedure will allow to evaluate the effect of the
balloon inflation itself on tubal function, compared to the insertion of catheter tube for
probing and flushing in the Eustachian tube only. The literature reports very low rates of
complication of BET surgery making this control procedure acceptable in terms of risks. The
use of this type of control procedure is justified by the fact that no other reference
treatment can be proposed as a reference group, and blinding the patient to the
investigational arm is needed to ensure the methodological validity of the study.
Simplified study calender:
Visit 0: Selection Visit During this visit, investigators will inform patients of the study.
Visit 1: Inclusion Visit (14 days - 3 months after V0):
The subject consent will be obtained. Medical and demographic data will be collected and
study examinations will be performed. Patients will be also received for an anesthesiology
consultation and after randomized the in the intervention or the control group arm.
Visit 2: 2 days-3 months after V1 Intervention under general anaesthesia: ETD or control
procedure.
Visit 3: 2 months (±15 days) after V2 Medical data collection and study examinations as well
as ETDQ-7 questionary (Eustachian Tube Dysfunction Questionary).
Visit 4: Final Visit - 6 months (±15 days) after V2 Medical data collection and study
examinations as well as ETDQ-7 questionary. End of the study for the participant.
Unscheduled visits If subject gets in contact with the site between regular visits due to
acute disorders, an unscheduled visit will promptly be performed at the site. During this
additional visit a physical examination, a systematic interview for recording of Adverse
Event should be performed.
