Feasibility Study of Balloon Eustachian Tuboplasty (BET)

Not Applicable

Withdrawn

• Conditions: Retraction of the Pars Tensa of the Tympanic Membrane; Retraction Pocket of the Tympanic Membrane; Eustachian Tube Dysfunction
• Interventions: Device: Bielefeld balloon

• Registration Number: NCT02631187
• Lead Sponsor: University Hospital Plymouth NHS Trust

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)).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-01
• Study First Submitted QC: 2015-12-15
• Study First Posted: 2015-12-16
• Study Start: 2016-03
• Status Verified: 2016-10
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Last Update Submitted: 2017-11-15
• Last Update Posted: 2017-11-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Balloon Eustachian Tuboplasty	Bielefeld balloon	Balloon Eustachian tuboplasty = dilatation of the cartilaginous Eustachian tube with a balloon catheter device performed with endoscopic control under general anaesthetic

Primary Outcome Measures

Name	Time	Method
Acceptability	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	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	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 Outcome Measures

Name	Time	Method
Cost analysis of treatment	1 year	Cost analysis of BET vs. cartilage tympanoplasty
Comparison of otoendoscopy images	Assessed pre-intervention and post-intervention at 2 weeks and 6 months.	Comparison of otoendoscopy images by two experienced observers and computer software (ImageJ). Assessed pre-intervention and post-intervention at 2 weeks and 6 months.
Demand	1 year	Demand assessed by recruitment rate
Tympanometry	Assessed pre-intervention and post-intervention at 2 weeks and 6 months.	Tympanometry (peak middle ear pressure and compliance, and Jerger grade (Improved, unchanged, worse)). 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.	PTA (air conduction at 0.25, 0.5, 1, 2, 3, 4, 6, 8kHz; bone conduction at 0.5, 1, 2, 3, 4 kHz) with calculation of air bone gap at 0.5, 1, 2, 3 and 4kHz. 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.	Ability to perform Valsalva measured as always, sometimes or never. Assessed pre-intervention and post-intervention at 2 weeks and 6.

Trial Locations

Locations (1)

Plymouth Hospitals NHS Trust; 🇬🇧 Plymouth, Devon, United Kingdom