Cricopharyngeal peroral endoscopic myotomy (C-POEM) as a treatment for dysphagia in Parkinson’s disease: a multicentre randomised controlled trial

Not Applicable

Conditions: Parkinson's disease
dysphagia
Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Neurological - Parkinson's disease

Registration Number: ACTRN12624000568516

Lead Sponsor: St George Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 52

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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in dysphagia symptoms[Sydney Swallow Questionnaire Baseline and 12 weeks following treatment];Change in upper oesophageal sphincter integrated relaxation pressure[Swallow assessment with high resolution impendace manometry Baseline and 12 weeks following treatment]

Secondary Outcome Measures