None listed
Conditions
Brief summary
Failure of the upper oesophageal sphincter (UOS) relaxation is frequently observed in Parkinson's Disease. It contributes to swallowing dysfunction which has enormous impact on quality of life and is an important risk factor for life-threatening aspiration pneumonia. The randomized controlled trial aims to determine the efficacy of a novel, minimally invasive endoscopic myotomy of the cricopharyngeus muscle (C-POEM) as a treatment for swallowing dysfunction attributable to failed upper oesophageal sphincter relaxation. Participants will undergo baseline assessments including pharyngeal high-resolution impedance-manometry (P-HRM-I) to confirm a diagnosis of UOS dysfunction. Participants with P-HRM-I features of failed UOS relaxation will be randomised to receive either: 1) C-POEM (treatment group) or 2) swallow therapy guided by a speech pathologist (control group). At 12 weeks following randomisation and completion of assigned treatment, participants from both arms will undergo repeat evaluation, including: patient-reported outcome questionnaires, P-HRM-I, videofluoroscopic swallow study and clinical outcomes. Participants in the control group who do not respond to dysphagia therapy will be offered a cross-over to undergo C-POEM.
Interventions
Cricopharyngeal peroral endoscopic myotomy (C-POEM) is a minimally invasive endoscopic procedure performed under general anaesthesia by an interventional endoscopist. The procedure is performed in a left lateral position. An initial submucosal bleb is followed by a longitudinal 1-2cm incision into the mucosa in the hypopharyngeal wall . Next, a short (5-6cm) submucosal tunnel is created extending into the proximal oesophageal wall thereby exposing the horizontal fibres of the cricopharyngeus. F
Cricopharyngeal peroral endoscopic myotomy (C-POEM) is a minimally invasive endoscopic procedure performed under general anaesthesia by an interventional endoscopist. The procedure is performed in a left lateral position. An initial submucosal bleb is followed by a longitudinal 1-2cm incision into the mucosa in the hypopharyngeal wall . Next, a short (5-6cm) submucosal tunnel is created extending into the proximal oesophageal wall thereby exposing the horizontal fibres of the cricopharyngeus. Full thickness dissection of the cricopharyngeus muscle (3-4cm in length) is then performed using the electric surgical knife. Lastly, the initial mucosal incision is closed with X-Tack Endoscopic HeliX Tacking System or through-the-scope endoscopic clips. The procedure duration is approximately 1 hour and entire procedure is video-captured and report documented in electronic medical record. Postoperatively, patients receive 24 hours of prophylactic intravenous antibiotics and analgesia on an as required basis. Essential medications (including Parkinson's Disease-specific medications) are permitted with sips of water after recovery.
Sponsors
St George Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Diagnosis of Parkinson’s disease Self-reported symptoms of oropharyngeal dysphagia Abnormal Sydney Swallow Questionnaire (SSQ) score (>234) Manometric evidence of failed upper oesophageal sphincter relaxation defined as an abnormally raised Integrated Relaxation Pressure
Exclusion criteria
Deep brain stimulator (DBS) – monopolar diathermy is contraindicated in DBS. Severe oropharyngeal dysphagia that had led to a previous or current recommendation to stay completely nil-by-mouth. Significant co-morbidities and/or advanced Parkinson’s Disease where risk of general anaesthesia is deemed unacceptably high. Hypopharyngeal structural disorders known to cause pharyngeal dysfunction (e.g., Zenker’s diverticulum, radiotherapy-related CP stricture) Oesophageal disorders known to cause dysphagia (e.g., achalasia cardia, peptic oesophageal stricture, eosinophilic oesophagitis etc). Insufficient cognitive capability to follow clinicians’ instruction or to provide informed consent (e.g., dementia).
Outcome results
None listed