Feasibility Study of Balloon Eustachian Tuboplasty (BET) for Grade 2 and 3 Pars Tensa Retractions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 2
- Primary Endpoint
- Acceptability
Study Overview
Brief Summary
This is a study that aims to evaluate the feasibility of undertaking a United Kingdom (UK) multi-centre randomised controlled trial of BET for the treatment of moderate (grade 2 or 3) retraction pockets (RPs). This future study will aim to address the question: Does BET improve symptoms scores, audiometry and otoscopic appearance of Grade 2-3 pars tensa RPs in adult patients?
Currently conservative treatments for this condition has been shown to be ineffective; there is a significant risk of progression to hearing loss or more serious complications in untreated retraction pockets; and the surgical treatments available to us in the UK not only have a number of risks and drawbacks, but also do not aim to treat the underlying cause (Eustachian Tube dysfunction (ETD)).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients over 18 years old with grade 2-3 retraction pocket of the tympanic membrane as assessed by study clinician.
Exclusion Criteria
- •Craniofacial abnormalities (assessed by history and examination)
- •Cholesteatoma (assessed by history, otoscopy, tympanogram, PTA)
- •Nasopharyngeal tumours (assessed by flexible nasendoscopy)
- •Adenoid hypertrophy (assessed by flexible nasendoscopy)
- •Patulous ET (assessed by history, otoscopy and tympanogram)
- •Previous middle ear surgery (assessed by history and otoscopy)
- •Concurrent use of anticoagulant medication
Arms & Interventions
Balloon Eustachian Tuboplasty
Balloon Eustachian tuboplasty = dilatation of the cartilaginous Eustachian tube with a balloon catheter device performed with endoscopic control under general anaesthetic
Intervention: Bielefeld balloon (Device)
Outcomes
Primary Outcomes
Acceptability
Time Frame: 6 months
Acceptability of the procedure, which will be assessed with pre- and post-procedure using the the seven-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7).
Patient Focus Group
Time Frame: 6 months
Thematic analysis of Patient Focus Group discussions. Standardised questions and focus group discussion with patients with (i) un-operated asymptomatic Retraction Pockets (RPs), (ii) un-operated symptomatic RPs, (iii) RPs treated with cartilage tympanoplasty, and (iv) RPs treated with BET. These will qualitatively assess (as appropriate) positive and negative aspects of patient experience, such as living with the RP, the procedure itself, their recovery, any after effects, and participating in the study. Focus groups will consist of 6 patients in each group.
Complications
Time Frame: 6 months
An assessment of the number of complications in the 20 participants undergoing BET will also be performed as a marker of safety of the procedure.
Secondary Outcomes
- Cost analysis of treatment(1 year)
- Comparison of otoendoscopy images(Assessed pre-intervention and post-intervention at 2 weeks and 6 months.)
- Demand(1 year)
- Tympanometry(Assessed pre-intervention and post-intervention at 2 weeks and 6 months.)
- Ability to perform Valsalva(Assessed pre-intervention and post-intervention at 2 weeks and 6 months.)
- pure-tone average (PTA) hearing loss(Assessed pre-intervention and post-intervention at 2 weeks and 6 months.)