Balloon Dilation of the Eustachian Tube in Children

Glue Ear Clinical Trial

Official title:

Balloon Dilation of the Eustachian Tube in Children: a Randomized Side-controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03499015
• Other study ID #: EK Nr: 1795/2017
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2018
• Est. completion date: October 1, 2020

Study information

• Verified date: November 2018
• Source: Medical University of Vienna
• Contact: Gerold Besser, M.D.
• Phone: 004314040033300
• Email: gerold.besser[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Otitis media with effusion (OME) is very common in children and characterized by fluid in the middle ear without signs or symptoms of acute ear infection. Treatment options are tympanostomy tubes and/or adenoidectomy. However OME often reoccurs after these procedures.

Goal of this study will be to evaluate the Balloon Eustachian Tuboplasty (BET) in children as an additional treatment option and to assess long-term effects of BET. Beside the standard procedure, children (4 to 10 years of age), with equal pathology on both ears, will be assigned for BET on side.

Description:

Introduction:

Otitis media with effusion (OME, "glue ear") is very common in children and characterized by fluid in the middle ear without signs or symptoms of acute ear infection. Fluid in the middle ear causes conducting hearing loss. OME has a large impact on health care costs and recurrent or persistent OME can effect the proper development of children. Frequently OME resolves itself, therefore guidelines strongly recommend watchful waiting for 3 months after which treatment options are tympanostomy tubes and/or adenoidectomy. However OME often reoccurs after these procedures. Furthermore there are various short and longterm side-effects of tympanostomy tubes.In Balloon Eustachian Tuboplasty (BET) a ballon catheter is used to dilate the cartilage part of the eustachian tube and is inserted through the nose to reach the opening of the tube, located in the nasopharynx. BET has recently been applied in children for therapy-resistant recurrent OME and inflammatory ear diseases with promising results. Risk and complications rates are very low.

Methods:

Goal of this study will be the evaluation of Balloon Eustachian Tuboplasty (BET) in children as a primary treatment of OME. Children between the ages of 4 and 10 years with OME and tympanometry type B on both ears, will prospectively be recruited and assigned for adenoidectomy and myringotomy. Parents then will be asked for participation in this trial and fully informed about purpose, technique and possible side effects. If consent is given, adenoidectomy, in case of large adenoids, and myringotomy will be performed on both sides. If necessary (very thick fluid) tympanostomy tubes are placed. One Eustachian tube of each patient is randomly assigned for BET.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

Inclusion Criteria:

• OME on both sides measured by flat tympanometry

Exclusion Criteria:

• Patients with cleft lip and/or palate and other severe craniofacial abnormalities

Related Conditions & MeSH terms

• Glue Ear
• Tube Disorders Eustachian

Intervention

Procedure:
• Balloon Eustachian Tuboplasty (BET)
A balloon catheter is used to dilate the cartilage part of the eustachian tube and is inserted through the nose to reach the opening of the tube, located in the nasopharynx.

Locations

Country	Name	City	State
Austria	Medical university of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (7)

Jenckel F, Kappo N, Gliese A, Loewenthal M, Lörincz BB, Knecht R, Dalchow CV. Endonasal dilatation of the Eustachian tube (EET) in children: feasibility and the role of tubomanometry (Estève) in outcomes measurement. Eur Arch Otorhinolaryngol. 2015 Dec;272(12):3677-83. doi: 10.1007/s00405-014-3443-2. Epub 2014 Dec 19. — View Citation

Maier S, Tisch M, Maier H. [Balloon dilation of the Eustachian tube in pediatric chronic obstructive Eustachian tube dysfunction patients]. HNO. 2015 Oct;63(10):686-8, 690-4, 696-7. doi: 10.1007/s00106-015-0050-5. German. — View 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. — View Citation

Popova D, Varbanova S, Popov TM. Comparison between myringotomy and tympanostomy tubes in combination with adenoidectomy in 3-7-year-old children with otitis media with effusion. Int J Pediatr Otorhinolaryngol. 2010 Jul;74(7):777-80. doi: 10.1016/j.ijporl.2010.03.054. — View Citation

Rosenfeld RM, Shin JJ, Schwartz SR, Coggins R, Gagnon L, Hackell JM, Hoelting D, Hunter LL, Kummer AW, Payne SC, Poe DS, Veling M, Vila PM, Walsh SA, Corrigan MD. Clinical Practice Guideline: Otitis Media with Effusion Executive Summary (Update). Otolaryngol Head Neck Surg. 2016 Feb;154(2):201-14. doi: 10.1177/0194599815624407. — View Citation

Tisch M, Maier S, Hecht P, Maier H. [Bilateral Eustachian tube dilation in infants: an alternative treatment for persistent middle ear functional dysfunction]. HNO. 2013 Jun;61(6):492-3. doi: 10.1007/s00106-013-2713-4. German. — View Citation

Van Roeyen S, Van de Heyning P, Van Rompaey V. Delayed-Start Study Design for Balloon Dilation of the Eustachian Tube: Alternative for a Randomized Controlled Trial. Front Surg. 2017 Feb 20;4:10. doi: 10.3389/fsurg.2017.00010. eCollection 2017. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	symptom-based side depended questionnaire	subjective scale side depended (zero to ten points - low to high disturbance by symptom). Symptoms asked for e.g. ear-fullness, pressure, pain, etc.	preoperatively and 9 months postoperatively
Primary	Tympanometry-Change (Middle ear effusion/eardrum mobility assessed with Tympanometry)	Tympanometry, an objective test of middle-ear function, uses variations of air pressure in the ear canal to assess for middle ear effusion / eardrum mobility.	up to 3 months preoperatively and change to 3, 6 and 9 months postoperatively;
Secondary	Otoscopy score	0= no effusion (Valsalva +/-, not feasible); retracted eardrum; Fluid or bubbles through eardrum visible; complete fluid blockage of middle ear	up to 3 months preoperatively and change to 3, 6 and 9 months postoperatively;