None listed
Conditions
Brief summary
To compare the benefits of using a new dumbbell shaped balloon dilator to expand the upper esophageal sphincter compared with the traditional round shaped balloon. The rest of the procedure will be the same. The dumbbell shape is more similar to the physiological shape of the UES normally, and can reach further side to side to treat scar tissues that form at the edges of the sphincter.
Interventions
INTERVENTION: Balloon dilation of the upper esophageal sphincter using a new shaped dilator (dumbbell shaped, figure-of-8).
Participants with obstructive dysfunction of the upper oesophageal sphincter (UES) will be offered balloon dilation. They may choose from a standard round balloon or a new dumbbell shaped balloon. Under either local anaesthesia or general anaesthesia, a flexible endoscope will be used to site a guide wire through the UES into the stomach. This will be used to thread a ba
INTERVENTION: Balloon dilation of the upper esophageal sphincter using a new shaped dilator (dumbbell shaped, figure-of-8). Participants with obstructive dysfunction of the upper oesophageal sphincter (UES) will be offered balloon dilation. They may choose from a standard round balloon or a new dumbbell shaped balloon. Under either local anaesthesia or general anaesthesia, a flexible endoscope will be used to site a guide wire through the UES into the stomach. This will be used to thread a balloon dilator onto, and across the UES region. The balloon will be inflated for 60s and held, then deflated completely. A second inflation of 45-60s may be performed depending on the first response. Then all instruments and the balloon dilator are removed. This will take place largely in the operating room but some patients may opt for the procedure under local anaesthetic in the clinic. The procedure is performed by Dr Allen, an Otolaryngologist. Allocation of balloon shaped to each patient is by patient preference. Follow up videofluoroscopy will be performed to analyse opening of the upper esophageal sphincter.
Sponsors
Te Whatu Ora Waitemata
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Oropharyngeal dysphagia (with or without feeding tube) due to upper esophageal sphincter (UES) dysfunction, of greater than 3 months duration, as documented by fluoroscopic swallow study. 2) Age 18 years and over 3) Diminished upper esophageal sphincter (UES) opening defined as less than .55 cm for individuals less than 65 years of age and less than .40 cm for individuals over 65 years of age on lateral images of fluoroscopic swallow study. 4) Failure of dysphagia therapy prior to study enrollment. 5) Able to undergo a short general anaesthetic or willing to attempt dilation under local anaesthetic in the office. 6) Ability to understand the informed consent and comply with follow-up, as evidenced by appropriate questions, responses, and comments during the initial evaluations.
Exclusion criteria
1) Oropharyngeal dysphagia not related to upper esophageal sphincter (UES) dysfunction. 2) Esophageal phase dysphagia as defined through personal history and/or documented diagnosis of esophageal dysmotility, hiatal hernia, eosinophilic esophagitis, malignant esophageal disease, erosive peptic esophagitis, and/or systemic disease affecting the esophagus. 3) Normal UES opening, as evidenced by UES opening greater than .55 cm for individuals under 65 years of age and greater than .40 cm for individuals over 65 years of age on fluoroscopic swallow study. 4). Age less than 18 years 5) Not having received dysphagia therapy 6) Malignant disease present in the oropharynx 7) Active tumor involving the cricoid or laryngeal cartilage. 8) Patients with orocutaneous or pharyngocutaneous fistulae at the time of evaluation. 9) Patients with current, at the time of evaluation, and/or documented history of subglottic stenosis, as evidenced on endoscopy (airway issues should be addressed prior to general anaesthesia). 10) Patients with current, at the time of evaluation, and/or documented history of airway obstruction, as evidenced on endoscopy.
Outcome results
None listed